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S.No TITLE DOCUMENT NO REVISION Page Nos

1 Concept note on API Project of 00
GULF OIL Corporation
Limited
2 Concept note on Process
Design Basis
3 Concept note on cGMP
requirements of equipments
4 Concept note on Civil and
Architectural designs
5 Concept note on Anti termite
treatment
6 Concept note on room finishes
7 Concept note on Ware house
8 Warehouse sizing calculations
9 Concept note on Sampling and
Dispensing
10 Concept note on Garment
change and procedure
11 Concept note on HVAC Design
basis
12 Concept note on HVAC System
13 Concept note on AHU zoning
14 Concept note on air handling
unit
15 Concept note on Pressure
Differentials in the HVAC
system
16 Concept note on Electrical
design
17 Concept note on Lighting
fixtures
18 Concept note on Piping design
19 Concept note on Process
systems, Process support
systems and Utility systems
20 Concept note on Room
numbering system
21 Concept note on Equipment
numbering
22 Concept note on numbering of
Utility lines
23 Concept note on AHU
numbering system
24 Concept note on Document
initiation, approval and
authorization
25 Annexures
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1.1 SITE LOCATION & LAY OUT

GULF OIL Corporation Ltd. (GOCL) is a pharmaceutical manufacturing company based at

Hyderabad, India. GOCL is India’s leading exporter of of various APIs. GOCL has
manufacturing facilities in three locations.

The state of the art facility, for API constructed at Pashamylaram is to cater to the regulatory
markets like USA, European Union & Australia. GULF OIL Corporation Ltd process to t.
The site for the construction of the new API manufacturing facility is located at Pashamylaram
Village, approximately 35 Km from Hyderabad in India.

The entire project will be designed in such a manner that it compiles with the cGMP
requirements/guidelines of US Food & Drug Administration (FDA), UK Medicines Control
Agency (MCA), World Health Organization (WHO), European Union and other relevant
regulations and standards both National and International.

The production buildings are at one end of the site. The Central Engineering, Utilities and
Waste disposal areas are located at a remote corner away from the site entrance and the rest of
the buildings. A large area at the front of the site is left clear for the future development when
needed.

The site will have well laid out Concrete roads with storm water drains on either sides. The
rainwater drainpipes will be provided as needed and they will be camouflaged with the
elevation of the buildings. All the open areas will be landscaped to prevent soil erosion and
dust generation in the site. Under ground sprinkler system will be considered.

Segregation of vehicle access and movement, and personnel access and movement is achieved
both at the site entrance gate and along the internal roads and designated pedestrian foot paths.

1.11 Facilities

The facilities contain 2 production streams. Stream #1 for Paracetamol and Stream #2 for
----------------------. (Refer MWZI/GOCL/S – 3143/001,002, 003 & 004 for Floor Plans,
material movement and personal movement)

Each stream at any stage will be dedicated line and only one product will be produced. The
production scheduling will permit adequate time for equipment and, facility cleaning.

The manufacturing area will be kept clean to keep the area free from extraneous contamination.

Stream #1 consists of a reaction area, a dedicated room for final crystallization, a centrifuge
room for separation process, Drier and Blender rooms for powder processing with a common
personnel change area. The stream #2 will have the same arrangements of rooms.
Page 3 of 53
1.12 API product Building

This will include the areas listed below, together with their necessary support areas:-

 Raw material warehouse with 6 pallet high racking (i.e.: ground plus 5 above) for storage
of starting materials including Incoming goods area and Quarantine
 Finished goods Warehouse (6 Pallet high racking).
 Dispensing area
 ------------------------- manufacturing area.
 ------------------------- manufacturing area.

1.13 Building Design Philosophy

The API manufacturing facility is intended to have separate production blocks to manufacture
-------------------- and -------------------.

The production building has been configured in a straight line to enable the flow of materials to
start from RM Ware house and finish in FG warehouse.

The building is conceptualized in two tiers for both manufacturing areas. The material transfer
will be either by gravity or by vacuum.

The proposed building concept layout provides a logical flow of personnel, materials and
equipment, minimizing movements throughout the process cycle.

It has been designed that the corridors and manufacturing areas be provided with glazed wall
panels to enable good visibility to the operators with in the manufacturing rooms, and also
enable visitors to view the operations from corridors without the need to access the
manufacturing environments.

The production building is designed as a controlled area, within which there will be two
categories:-

 Areas where product is not exposed (i.e. Wear houses.)

 Areas where product is exposed to the processing environment (eg: dispensing and
manufacturing).

All these areas are provided with appropriate finishes and air quality to comply with the cGMP
guidelines relevant to the stage of the process. In the areas where the product is exposed during
operations, the environment (both air quality and air finishes) will be of the highest standard
appropriate to the product and process stage. Instead, where the product is in its final packing
(eg: warehouse), provision is required simply to endure that storage conditions are sufficient to
prevent degradation of the product, which will reduce its shelf life.

In terms of environmental finishes and air quality, each change area and airlock into it, are
designed and maintained to the level of the higher standard area that it gives access to.
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1.14 Internal finishes

Appropriate standards of internal finishes are provided in each area of the production building
to meet the relevant GMP Guidelines.

Classified areas

Classified area defines an ISO 8 Class confirming to a class 100,000 environment at rest and is
recommended for non – sterile processing e.g: Dispensing, Powder processing and packing
areas.

These conditions are achieved by the use of a Terminal HEPA filter near to the room, a
minimum of 40 air changes per hour, and a minimum of 1.5 mm of Wg pressure differentials
from an area of lower classification. ISO 8 Class areas are protected by air lock and personnel
change common for entry and exit.

Walls – Brick work plastered both sides and painted with Polyurethane / Epoxy on prepared
wall substrate: coved at junctions and corners or Modular GI powder coated clean room wall
panels.

Ceilings – Coved at wall junctions, painted with Polyurethane / Epoxy paint on prepared
ceiling substrate to underside of concrete slab above; or modular panel false ceiling system.

Floors and coving – PVC with integral coving on prepared substrate;

Doors – Special factory produced “Pharmaceutical type” integral door and frame sets;

Integral glazed panels – GI Powder coated or Aluminum framed double glazed flush or near
flush with wall surfaces and silicone bead around.

Non - Classified areas – (e.g.: Technical manufacturing areas, Quarantines, Warehouse,

Corridor areas etc)

Walls – Suitable quality Emulsion paint on prepared, cement plastered brick walls, no coving at
junctions and corners.

Ceilings – Suitable quality paint on prepared substrate;

Floors and coving – Epoxy paint on prepared screed substrate with Coving.

Doors – Appropriate quality door and frame sets.

Internal glazed panels – GI Powder coated or Aluminum framed single glazed panels with
sloped sills.

1.15 Internal designed conditions

The internal environmental conditions provided by the various HVAC systems particularly in
the powder processing areas will be subjected to appropriate levels of monitoring and
qualification to confirm that they remain within the predefined compliant operational
range continuously 24 hours/day, 7 days/week.
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Within the areas of the production building where quantities of powders are handled, there are
concerns of airborne cross – contamination via the HVAC system. Therefore, careful
consideration is given in the HVAC systems zoning and control measures.

Local dust extract points will be provided to remove dust from certain equipment within the
manufacturing area and ducted to a dedicated dust extraction unit fitted with suitable grade
filters and dust collection units prior to the exhaust air being discharged to the external
atmosphere. The removal of this dust from the collection units and its transport to the disposal
area is under taken according to appropriate ‘ safe change’ standard operating procedures.

Appropriate levels of lighting are to be provided throughout the facilities in accordance with
local regulations; however the lighting levels stated below is the minimum recommended in the
specific areas listed:

 Dispensing, Manufacturing and packing 400 lux at working plane

areas
 Laboratories and Write Up areas 400 lux at working plane
 Corridors 250 lux at floor level
 Ware house 250lux at working plane

1.16 Drainage and Effluent treatment

Separate drains will be provided for the Process Effluents, Sanitary, Storm water, Boiler blow
down and RO reject. Inspection chambers of suitable sizes will be provided at regular intervals.

Process effluent will flow through underground HDPE pipes to Effluent treatment plant. The
effluent will be preliminarily treated in ETP located at one corner of the site and this treated
effluent will be sent to common effluent treatment plant for further processing. However it is
also proposed to isolate the Lean effluent (i.e: effluent generated during Personnel wash) which
shall be treated and can be reused for Gardening and for cooling towers.

1.17 Safety

The project has a responsibility for safety. The facility will have a well – developed safety
program. This program will be in place room early site work. Good safety practices will be
applied to construction site, which shall be modified as each phase is completed, minimize
injuries to personnel and damage to equipment and the environment. All personnel working
within the facility will be made aware of potential hazards and training will be imparted to
address specific safety issues.

Special safety precautions will be considered which include:

 A “Changed Lines” board.

 Look out and tag out enforcement.
 Providing spill kits
 Making burning / cutting permits mandatory.
 Providing safety showers and eye wash stations.
 Providing confined space entry training.
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 Providing training on tools and equipment utilized in a classified (electrical)
location.
 Maintaining a readily accessible file within the facility containing the
Manufacturers safety Data Sheets (MSDS) for all chemicals, fluids and compounds stored
or present within the facility.
In addition to above, facility will be equipped with

 Fire hydrant system.

 Smoke detection & Fire alarm system.
 Fire extinguishers.

OPERATIONS

2.0 Process and Production Forecasts

The process and equipment for the production facilities have been defined from analysis of the
product list and volume forecasts supplied by GULF OIL Corporation Ltd. The data was
analyzed to confirm the actual number of items o process equipment that need to be
accommodated in the layouts and the processing technologies suggested in the Basis of Design.

2.1 ------------------- manufacturing

The manufacturing of Paracetamol involves the following stages, as indicated in Product

details, Process Block diagrams and process flow diagrams ( as per Annexure 1A, 1B & 1C)
a) Acetylation
b) Separation
c) Purification
d) Separation
e) Drying & size reduction.
f) Blending
g) Metal detect
h) Ion
i) Packing

a) Acetylation:

This reaction step takes place in 16 KL capacity SS 316 L reactor. Para Amino phenol reacts
with Acetic Anhydride to give Paracetamol (Technicial). The completion of the reaction is
tested for the presence of Para Amino Phenol to below 0.45 %. The material is cooled to 15ºC
to facilitate the Crystallization of the product

b) Separation:

The reaction mass from the reactor will be centrifuged in a Pusher Centrifuge, of 4tones/hr
capacity, with continuous solids and mother liquor discharge. The cake is washed with purified
water. The mother liquor from centrifuge is further processed for acetic acid recovery.

c) Purification:

The centrifuge cake is transferred to the purification Reactor of 24 KL capacity, where it is

dissolved by heating to 95ºC in purified water for carbon treatment. The mass is agitated for 30
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minutes after activated carbon is added. The mass is filtered through a Leaf, Line followed by
micron filters. The filtered material is collected in a 24 KL SS 316L Reactor or crystallization.
The mass is cooled to 15 - 20ºC by circulating chilled water in the jacket. However an option of
going for continuous crystalliser shall also be looked into.

d) Separation & Drying

The separation will take place in a continuous Pusher Centrifuge of 4tones/hr capacity and
drying and size reduction will be done in a Spin flash drier of 3tones/hr capacity.

e) Blending:

The dried material is transferred to 18 KL capacity SS 316 Ribbon Blender/or Nauta Mixer for
blending the entire mass to uniformity. The Blended material shall pass through a metal
detector before it is packed for dispatch confirming Quality checks.

Note: i) A separate facility with 250Kg fluid bed drier and 1000 Kg/hr Pulveriser will be
provided to cater to the specific needs of the customers.

ii) ML (Technical) – It is proposed to recover Acetic Acid.

iii) ML (Pharma) – It will be separately distilled by using multiple effect evaporator /

will be recycled to Acetylation stage.

iv) It is also proposed to consider a system for recovering the product from the solid
waste, if it meets the quality parameters.

The list of Equipments and capacities considered as per Annexure 2.

Metformin HCl manufacturing:

The manufacturing of Metformin HCl involves the following stages as indicated in product
details, Product block diagram and process flow diagrams (as per Annexure 3A, 3b & 3c)

a) DMF Dehydration
b) Condensation reaction
c) Separation
d) Purification
e) Separation
f) Drying
g) Milling
h) Blending
i) Metal detector
j) Packing

a) DMF Dehydration

DMF De hydration teaks place in 6 KL SS316 L Reactor. The dehydrated mass is used as a
medium in the condensation reaction.

b) Condensation reaction
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This reaction step takes place in a 9 KL capacity SS 316 L Reactor. Dicyandiamide reacts with
Dimethylamine HCl to form Metformin HCl (Technical). The reaction mass is cooled to 15ºC
using cooling water and chilled water.

c) Separation

The reaction mass from the Reactor will be centrifuged in a Pusher Centrifuge of 3tonnes/hr
capacity. Washing of wet cake is with DMF. The mother liquor from centrifuge is further
processed for DMF recovery.

d) Purification

The technical Metformin HCl from Centrifuge is dissolved in 70 % Methanol by heating to

reflux in a purification vessel of 17 KL capacity. Activated carbon is added to decolorize the
reaction mass. The mass is filtered through a leaf, line followed by micron filters. The mass is
cooled to the 5 – 10ºC temperature for crystallization.

e) Separation & Drying

The crystallized solid is separated in a 13 KL Agitated nustche filter with a facility for drying.
The product is washed with Methanol.

f) Milling

The dried material is milled to the required particle size in a Multi mill of 600 Kgs/hr capacity.
The material of construction of Multi mill will be SS 316L.

g) Blending

The milled material from Multi mill and transferred to 18 KL SS 316L Ribbon Blender/ Nauta
mixer for blending the entire mass to uniformity.

The blended material shall pass through a metal detector before it is packed for dispatch
confirming Quality checks.

Note: ML from purification stage will be taken for recovery of solvent in a multiple effect
evaporator.

The list of Equipments and capacities considered are as per Annexure 4.

2.2 Capacity Calculations

The equipment needs and capacity calculations are based on the following assumptions.

 312 working days per annum, based on 52 weeks and 6 days per week.
 8 Hours per shift
 Three shifts / day

2.3 Storage Requirements

 Raw materials
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 Primary Packing materials
 Fiber board / HDPE drums / HDPE bags

In addition, space has been provided for the receipts, marshalling and sampling and Dispensing
of materials, and for the picking and packing of finished goods orders for delivery to
customers.

The warehouse dimensions have been based on estimated pallet quantities required to hold the
stock levels.

2.4 Transfer of samples etc to QC Laboratories

Various items need to be transferred from the production buildings to the QC Laboratory
buildings:

 Raw material samples from the sampling area.

 Packaging components samples from Goods Receipt area.
 Samples from production processes/bulk finished product.

2.5 Laboratory Requirements

The laboratory requirements will be provided:

 Quality Control Analytical Testing Laboratories;

 Quality Control Microbiology Laboratory Support Functions.

The QC lab will be designed to meet international standards with reference to Good
Laboratory practices. The lab will be equipped with state of the art equipments like HPLCs,
GLCs, UV visible spectrometer, FTIR, Autoclaves, Ovens, and Incubators. The lab facility will
be designed to have Wet Chemical lab, Instrument lab, Microbiology lab, Stability rooms,
control samples room etc. The environmental conditions of the Micro lab will be similar to that
of the manufacturing area.

Separate Documentation storage room will be provided where all the documents related to the
facility will be stored. The access shall be for authorized personnel only.

2.6 Product segregation and Containment

The design provides separate facilities for Paracetamol and Metformin HCl in order to
provide the level of segregation expected by regulatory authorities.

To further prevent the risk of cross – contamination, the following points are planned:

The design of building is made to ensure that dedicated systems exist for HVAC systems and
that stringent controls exist to control personnel movements to avoid contamination being
carried into other areas. Personnel working within the area are adequately protected from dust
emissions generated during manufacturing activities. This protection may also take the form of
personal protective equipment, in addition to the special features designed to contain dust,
which will be included in the chosen process machinery.
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Appropriate measures are taken to ensure that Powders are contained within the building and
do not escape to the external environment. In the areas which are open to their operating
environment (e.g.: dispensing), the design is made to provide measures for containing in the
following ways:-

 Dust control and collection

 Filters on air discharged to the external atmosphere.

 Personal garment change when entering during exit

 Air locks where materials exit and enter.

2.7 Manpower and working Pattern

The facility will be operational on a continuous production basis. This is based on a 24 hour,
three-shift system. The staffing numbers per shift are as under:

Suite - 1 Suite - 2
Shift – 1
Process 15 10
Engineering 6 (Common for both suites)
Others 4 (Common for both suites)

Shift - 2 Process 15 10
Engineering 6 (Common for both suites)
Others 4 (Common for both suites)

Shift - 3 Process 15 10
Engineering 6 (Common for both suites)
Others 4 (Common for both suites)

General Shift
Process 8 8
Engineering 8 (Common for both suites)
Others 15 (Common for both suites)

The change facilities shall be designed to service the personnel as estimated above with an
additional allowance for visitors.

2.8 Personnel, Product, Raw material and waste flows:

The movement/flow of personnel, product, raw materials, waste, etc., shall be unidirectional
flow to the extent possible with minimum criss-cross or mix up. The building layout shall
facilitate achieving of he above.

2.9 Access and Garment Regime

All personnel entering the production buildings will do so via an appropriate garment changing
regime.
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The Garment regime enforced is designed to give, to both product and operator, appropriate
protection against contamination. Therefore, variations in garment will be needed in production
areas where there are differing product risks. Additional garments or items of personnel
protection may be required for particular hazards associated with certain process steps.

All personal will be provided with a personal locker where they can securely leave the outer
clothing and shoes as hey arrive at work, along with any other personal items.

Personnel are expected to change into a general factory uniform collected from dedicated
lockers and put on their “factory shoes” kept in the change room. The general factory uniform
will provide personnel with access to the general circulation corridors, warehouse, Technical
manufacturing areas etc.

These garments shall be transferred from the in house laundry to the appropriate change rooms,
which shall then be taken to designated lockers by the working personnel. A dedicated pair of
shoes will be issued to each person and shall be collected back at an appropriate interval either
disposal or for cleaning, which shall be reissued again to the working personnel.

Further change, or donning of over-garments (e.g.: Boiler suits / aprons) will be required when
personnel enter their respective work area (e.g.: dispensing, Powder processing areas, Packing
areas, etc).

Visitors will be expected right from their arrival at the building to use the change facilities
provided exclusively for them. Before visitors enter manufacturing area they will change to
over gown with a disposal garment, which will be of similar standard that of garment
designated for that area.

Smoking is not allowed anywhere within the premises.

2.10 CIP Concept

Cleaning is an extremely important issue in a pharmaceutical facility with regard to product

and QA requirements.

There are two classes of equipment subject to cleaning cycle : fixed equipment that will be
cleaned in place (CIP Concept) and equipment that will be cleaned in the washing area. The
Crystallizers, Pusher Centrifuge, Blender etc. are clear examples of the first group whereas the
Scoops, Meshes, Filter bags etc. belong to second group.

Appropriate systems will be selected based on the above concept.

2.11 Documentation

A well-planned road map defined, as validation master plan will be prepared to compile the
documents required for the facility. The documents will include design reviews, layout
drawings for execution, as built drawings, etc. A list of documents required to be prepared will
be made to ensure that all required documents are prepared and kept as documented evidence
for all activities. A comprehensive documentation package consisting of the following
documents will be prepared:

 User Requirement Specification (URS)

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 Validation Master Plan (VMP)

 Design Qualification (DQ)

 Installation Qualification (IQ)

 Operational Qualification (OQ)

 Performance Qualification (PQ)

 Process Validation (PV)

2.11 Validation

This facility will comply with the EU and US FDA GMP regulations, be able to successfully
sustain GMP regulatory inspections and be able to export its products to the markets regulated
by these authorities. Therefore the facility, its utilities and equipment need to be qualified, and
the process validated.

Successful qualifications demonstrate that the facilities, utilities and equipment are fit for
purpose and can repeatable perform to the required parameters. To ensure a successful
qualification to EU and FDA requirements, the necessary tasks have been planned from an
early stage of the project and to inter\grate them with the design and construction program.

Appropriate requirements for this have to be written and included in the detail design and
technical specifications of the facility, utilities and equipment packages, so that the necessary
documentation needs are defined and incorporated into their purchase orders.

2.12 Production Start - Up

The facility start-up has been planned as a project in its own right and it will run in parallel to
the design, construction, installation and qualification of the facility.

Start-up planning will need to encompass:

 Preparation of recruitment plan

 Writing of production, engineering and QA/QC SOPs

 Set-up of site documentation e.g. Site Master File, Batch

Manufacturing documents, QC Testing documents, etc.

 Procurement of test materials such as blank packaging

materials, etc for equipment testing during vendors
Factory Acceptance Tests (FATs) and on-site
commissioning and qualification testing.

 Set-up of purchasing and planning systems to ensure raw

materials and packaging components with the correct
artwork are available on time.
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 Start-up of QC laboratories in advance of production
facilities to meet commissioning and qualification testing
requirements.

HO NHCOCH3

TABLE to be drawn here

Annexure - 2

S. No Equipment Capacity Qty MOC

1 Reactor 16 KL 1 SS 316 L
2 Crystallizers 16 KL 2 SS 316 L
3 Charcoliser 24 KL 2 SS 316 L
4 Crystallizer (Pharma) 24 KL 2 SS 316 L
5 Pusher Centrifuge (Technical) 4 Tonnes/Hr SS 316 L
6 SS 316 L
7 SS 316 L
8 SS 316 L
9 SS 316 L
10 SS 316 L
11 SS 316 L
12 SS 316 L
13 SS 316 L
14 SS 316 L
15 SS 316 L
16 SS 316 L
18 SS 316 L
19 SS 316 L
20 SS 316 L
21 SS 316 L

S. No Equipment Capacity Qty MOC

1 Reactor 16 KL 1 SS 316 L
2 Crystallizers 16 KL 2 SS 316 L
3 Charcoliser 24 KL 2 SS 316 L
4 Crystallizer (Pharma) 24 KL 2 SS 316 L
5 Pusher Centrifuge (Technical) 1 SS 316 L
6 1 SS 316 L
7 1 SS 316 L
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8 1 SS 316 L
9 1 SS 316 L
10 1 SS 316 L
11 2 SS 316 L
12 2 SS 316 L
13 2 SS 316 L
14 4 SS 316 L
15 2 SS 316 L
16 2 SS 316 L
17 2 SS 316 L
18 2 SS 316 L
19 2 SS 316 L
20 3 SS 316 L
21 1 SS 316 L

PROCESS DESIGN BASIS

1.0 INTRODUCTION

M/S GULF OIL Corporation Limited. Is getting a bulk API facility for the production of
Paracetmol and Metformin HCl. The plant is to be located at Pashamylaram in Medak.

All facilities will be designed to meet the requirements of USA – FDA, UK – MCA
standards.

2.0 PLANT OPERATION

The plant will operate for 312 days per annum based on 52 weeks and 6 days per week, on
a three shift per day basis. Working time per shift will be 8 hours.

3.0 PRODUCTION CAPACITIES

Plant will be designed to meet the capacity requirements as follows:

PARACETMOL:

Total production: 600 Tonnes / Month

Metformin. HCl:

Total production: 150 Tonnes / Month

4.0 PRODUCTION FACILITIES

Paracetamol and Metformin HCl facilities will be independent of each other with separate
buildings, manpower etc. However utilities like steam, comp. & inst. Air etc. and
warehouse will be common for both plants.
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4.1 Raw Material, Finished Goods & Packaging material Storage.

Raw materials warehouse and Finished goods/Primary packing material warehouse are
separated.

4.2 PROCESSING FACILITIES

Reaction, Separation, Purification, Filtration, Drying, Milling and Blending areas are
considered.

Flame proof areas to be considered for Metformin HCl manufacturing.

Appropriate level of equipment is maintained in packing area.

4.3 PACKAGING

Highly controlled environment is maintained in packaging area.

4.5 LABORATORY

All QC/QA facilities for both products will be in a common building with separate suites
for sample testing of products of different categories.

5.0 UTILITIES

Utilities will be common for both the plants. New facilities will be provided for each
utility, requirements for which have to be worked out. Following utilities will be provided.

1. Steam
2. Compressed air
3. DM Water
4. Purified Water
5. RT Water
6. Chilled Water
7. Chilled Brine
8. HSD : For D. G set
9. Coal : For Boiler
10. ETP
11. Fire Hydrant Water
12. Drinking Water : UV Sterilizer to be provided at end use point for
providing drinking water from filtered water
13. Nitrogen
Page 16 of 53

cGMP REQUIREMENTS FOR

PHARMACEUTICAL EQUIPMENT

1.0 TECHNICAL INFORMATION

1.1 Scope of supply will be for following API manufacturing sections:

a. PARACETAMOL
b. METFORMIN HCl

1.2 The capacity of these sections will be:

a. PARACETAMOL

Paracetamol :600 MT / Month

Total production : 600 MT / Month

b. METFORMIN HCl

Metformin HCl : 150 MT / Month

Total Production : 150 MT / Month

Note: The above capacities are based on Three shift operation per day and 312
working days per year based on 52 weeks and 6 days per week.

1.3 The Paracetamol Section will consist of minimum of following:

a) Acetylation
b) Separation
c) Purification
d) Separation
e) Drying & Size reduction
f) Blending
g) Metal detector
h) Packing

1.4 The Metformin HCl section will consist of minimum of the following:

a) DMF Dehydration
b) Condensation reaction
c) Separation
d) Drying
e) Milling
f) Blending
g) Metal Detector
h) Packing

All the equipments will be as per cGMP Standards.

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Besides the above manufacturing facility, raw material and finished product
handling storage facilities are also to be considered as applicable.

1.5 The following tag nos. and the equipment list is based on the following process flow

a) Process flow of {aracetamol manufacturing

b) Process flow of Mtformin HCl manufacturing

1.6 The dimensions of the room where the equipment to be installed are as indicated
on the drawings.

2.0 SCOPE OF SERVICES

scope of services include Design, manufacture, supply, installation, supervision and

commissioning assistance for complete manufacturing lines.

Design of equipment will meet with US FDA Guide lines.

Commissioning assistance include supervision of erection of equipment & their

alignments, trail run of equipment with and without dummy materials as per
specified capacities as shop and after installation.

To submit DQ/IQ/OQ validation protocols based on URS and to fill up the same
during Factory Acceptance test (FAT), installation and Site Acceptance Test (SAT)
documents and submit the same.

Vendors offer will be complete with literature and catelopue of all the items offered,
process flow diagrams, equipment and piping ducting layout (with dimensions), the
information required on the equipment specs such as dimensions, electrical details,
utility requirement, utility hook – up details, installation drawings, P&Ids, etc.

The installation will meet the highest standards of cGMP and international standards
of construction.

Exclusions from scope of supply.

 All civil work

 Utility like water, compressed air, steam supply up to one point in the room,
wherever required

 Electric supply up to one point in the room, wherever required.

 HVAC systems.

3.0 TECHNICAL REQUIREMENTS

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All the equipment to be of cGMP construction. It will comply with validation
requirements of US FDA or any other international regulatory authority and easily
accessible for through cleaning. The same to be maintained in the offer.

 Equipment and machinery will be subject to inspection and factor acceptance

tests at vendor’s shop prior to dispatch.

 Interphasing / integration/ line balancing of all items of process equipment

will be the responsibility of supplier. For this purpose, if additional
equipment is required, same will be specified by vendor. This will include:-

 Working Heights
 Process speeds
 Emergency stops

Required interlocks between the machines to be provided by vendor.

 Vendor will ensure necessary synchronization of line as per requirements.

 Vendor will specify requirements of associated civil works for the equipment
offered including cutouts, inserts, foundation, etc.

 All parts in contact with product materials are of SS 316 unless otherwise
specified.

 All external finishes to be uniform 180 grits satin (matt finish) and internal
finishes to be mirror polished (320 grits) for metal surfaces in product
contact.

 All welds in contact surface to be crevice free, ground smooth and

passivated. Passivation certificates should be provided

 All instruments including electronic controls should be calibrated and

calibration certificates to be provided (traceably to National Standards to be
informed by vendor).

 Certificates for the following should be provided wherever applicable.

M.O.C., Pressure Test, Dynamic Balancing, Performance test, Vibration Test,
Noise Level Test, Cleaning.

 The equipment will be designed & constructed to suit its intended use and to
facilitate maintenance as well as easy and thorough cleaning.

 The equipments offered should comply with internationally approved GEP

standards and the contactor should specify the standards to which each
equipment compiles with.

 Welding certificate and weld logs to be provided.

 All valves in the equipments will be in accordance with process requirement

and will be Hygienic/sanitary design.
Page 19 of 53

 All asbestos Free insulation wherever applicable will be suitably clad with
S.S. – 304 unless otherwise specified with uniform satin finish.

 All connections will be tri – clamps type and not screw type.

 Equipments will be with hygienic/sanitary design.

 All jacketed reactors shall be designed as per the ASME codes for pressure
vessels.

 The Reactors are to be equipped with heating/cooling jacket in the cylindrical

and bottom dish.

 Insulation cladding shall be of tank in tank type.

 The sealing system at flange joints shall be PTFE / EPDM or other

pharmaceutical grade material.

 Design pressure considered for vessel shall be –1 / +5 Kg/Cm2.

 Design pressure considered for jacket / limpet coil shall be –1 / +6 Kg/Cm2.

 Design temperatures for reactor and jacket shall be 150 C.

 Suitable nozzles should be provided on top dish for installation of pressure

gauges temperature measuring devices.

 All flanges should be ANSI rated according to pressure vessel code.

 The agitator assembly should be designed and constructed in such a way to

facilitate the complete removal of material from the designated reactor.

 Mechanical seals should be used to seal the stirrer shaft to the reactor.

 Every power supply feeder to the equipment will be protected using

MCB/Fuse Unit.

 Separate and dedicated arrangement will be made for the power and
electronics earthing network connections in the panels.

 All drive motors to be TEFC / Flame proof (Wherever needed), suitable for
440 V  5% 3 Ph 50 HZ  3% supply having IP 55 enclosure. Flame proof
motors and enclosure to be considered as mentioned in URS.

 All the equipment to be provided with DOL / Star-Delta starter with overload
relay for protection against single phasing and low voltage.

 All elect. Items will be with IP 55 enclosures, unless otherwise specified.

Page 20 of 53
 All bought out items should be of reputed make meeting international
standards. The make should be specified in the quotation.

 Any changes in the given specifications should be highlighted in the

quotation.

 All equipment offered should be guaranteed for workmanship and quality of

materials for a minimum period of one year from the date of commissioning.

 Design Qualification (DQ), Installation Qualification (IQ), Operational

Qualification (OQ), Performance Qualification (PQ) Protocols will be
submitted for approval with in 2/3 Weeks on receipt of Valid Purchase order.
These protocols will be completed during FAT, installation & SAT.

 Operation & Maintenance manuals will be submitted for recr\ords in

triplicate.

 The service requirement for each equipment will be clearly indicated. The
service hook-up details to be provided .

 The detailed equipment layout drawing with dimensions within the specified
room to be provided.

 Commissioning methods and commissioning tests/ Qualification /

Acceptance criteria will be specified either in operation manual or in
commissioning document to be submitted prior to delivery of equipment, at
the earliest.

 Construction certificates will be provided

 The type and number of filter will be specified. The filter housing will be
cleanable.

 The thermocouples, provided, will be in accordance with process

requirements.

 Mechanical seal, in case provided, will be in accordance with process

requirements.

 Noise level – The noise level will not extend 75 DB (A) up to around 1Mtr.

 Training to operators to be carried out and documented evidence to be

submitted.

1.0 CONSTRUCTION TYPE, METHOD OF DESIGN AND MATERIALS

1.1 CONSTRUCTIN TYPE:

Columns are to be cast-in-situ concrete with isolated footings of grade not less than M20.
Superstructures of monolithic construction of beams and columns Cast-in-situ of Min. M20
grade along with Plinth Beams. Exterior alls are of brick masonry with CM 1:6.
Page 21 of 53

All the cement plastered surfaces of inner walls to be Painted Polyurethane aliphatic paint. All
cement plastered surface of outer walls are to painted with cement plant i.e.; snowcem or
equivalent grade. Flooring is of smooth VDF flooring to carry out the epoxy tapping of 2mm
thick. Doors are made of galvanized steel sheet press formed to double rebate proof of suitable
size with all accessories. While windows are of double glazed type.

1.2 METHOD OF DESIGN

Based on the soil investigation report, a cast-in-situ concrete spread footing and concrete
columns and beams for structures shall be proposed. Structures and structural elements shall
normally be designed by limit state method with the following loads considering safety and
serviceability requirements as per clause 35 IS 1456 – 2000 with safety factors (Table 18 page
68 of IS 1456). Isolated RCC footings will be at 2.5m to 3m depth. The building is designed as
monolithic 3 floors RCC framed structures made of R.C.C with external brick walls.

1.2.1 LOADS

a) DEAD LOAD

Dead Loads Calculated on the basis of unit rate of material I.S. 875
as given below.,
Unit Rate of concrete .. .. .. .. 25 KN/m3
Unit of Brick masonry .. .. .. .. 20 KN/m3
Unit of stone masonry .. .. .. .. 20 KN/m3

b) IMPOSED LOAD (I.L) (IS 875)

Imposed load on the floors shall be taken as UDL .. 5 KN/m2

Besides equipment loads – Concreted load .. 4.5 KN

C) WIND LOAD (W.L) (IS 875)

The buildings are to be designed for basic wind speed for plant site Vb = 44 m/s

As per IS 875

VZ = K1 K2 K3 Vb
Vb = Basic wind speed
K1 = Probability factor or Risk coefficient for 50 Years 1.00
K2 = Terren, Height, & Structure Cat I group A factor 1.12
K3 = Topography factor 1.1
VZ = 1.00 x (1.12) x 1 x 44 = (49.28)
0.006 x (49.28)2 = 1.45 KN / m2 or 145 Kg/m2

1.2.2 EARTH QUAKE LOAD

Earthquake force shall be calculated in accordance with IS 1893 with the following parameters.

a). Sesmic coefficient Method

Page 22 of 53

Buildings are to be designed taking into account of Zone 3 with

Horizontal sesmic coefficient .. .. .. .. 0.04

And importance factor .. .. .. .. 1.00
Permissible increase in the Bearing capacity of soil for medium soil 25 %
N > 15 for isolated RCC footings with tie beams

b). Temperature effects

Expansion and contraction due to changes in temperature of the materials of a structure shall be
considered in design. Provision shall be made either to relieve the stress by provison of
expansion/contraction joints in accordance with IS: 3414 – 1968 or design the structure to carry
additional stress due to temperature effects as appropriate to the problem.

Maximum Temperature .. .. .. + 45C

Maximum Temperature .. .. .. + 5C

c). Load combinations

The following load combinations whichever combination produces the most unfavorable effect
in the building, foundation or structural member concerned may be adopted.

a) DL
b) DL + IL
c) DL + WL
d) DL + EL
e) DL + TL
f) DL + IL + WL
g) DL + IL + EL
h) DL + IL + TL
i) DL + WL + TL
j) DL + EL + TL
k) DL + IL + WL + TL
l) DL + IL + EL + TL

LEGEND:

DL – Dead Load
IL – Imposed Load
WL – Wind Load
EL – Earthquake Load
TL – Temperature Load

1.3 MATERIALS

GENERAL: a) All materials shall be best of their kind and shall conform to the latest Indian
standard.
b) All materials shall be approved quality as per samples and from origins.

1.3.1 CEMENT
Page 23 of 53

Ordinary Portland cement of grade 53 shall be used for all the workers where as Sulphate
resistant Portland cement shall be used for foundations confirm to latest IS 8112

1.3.2 COARSE AGGREGATE

Coarse aggregates shall conform to IS 383. If required aggregates shall be washed and screened
and sampling and testing shall be as per IS 2386. It shall consists of crushed broken stones 25%
of each shall be retained on 4.75mm IS test Sieve. Coarse aggregate shall be chemically INERT
when mixed with cement and shall be angular in shape and free from flakey pieces. It shall be
free form dust or other foreign matters.

1.3.3 FINE AGGREGATES

Sand G-97 conforms to IS 383 and shall be from natural source. It shall pass through IS
4.75mm test sieve leaving a residue not more than 5%.

The fineness of the modules shall range between 2.6 to 3.2.

1.3.4 WATER

Water used shall be portable quality fresh, clean, free from oil, salty acids, alkaline or shall be
in accordance with clause 5.3 of IS 456. Permissible limits shall be as follows.

S.No Particulars Tested as per Permissible Limit (Max)

1). Organic IS 3025 (Part 18) 200mg/l
2). Inorganic IS 3025 (Part 18) 300mg/l
3). Sulphates (as SO) IS 3025 (Part 24) 400mg/l
4). Chlorides (as Cl) IS 3025 (Part 32) 2000 mg/l
(For concrete not containing
embedded steel)
500mg/l (For reinforced
concrete work)
5). Suspended matter IS 3025 (Part 17) 2000mg/l

1.3.5 REINFORCEMENT

Reinforcement shall be high strength deformed steel bars confirming to IS 1786. All
reinforcement shall be free from loose mill scales, loose rust coats of paints, oil mud or any
other substances, which may destroy or reduce, bond sand blasting or other treatment as
recommended to clean reinforcement.

1.3.6 STONES

Stones shall be the type specified and shall be of hard granite be salt or trap stone of uniform
colour and texture. It shall be hard, sound, durable and free from flaws, cracks injurious veins,
decay and weathering and shall be freshly quarried from and approved quarry. Discolored or
Page 24 of 53
distorted stones with boulders skin or earth or porous matter or stones with round surface shall
not be used.

The crusting strength of the rubble for use in the stone masonry should not be less than
150Kg/Cm2.

1.3.7 BRICKS

Bricks shall conform to the requirements of IS 1077. Bricks of normal size 8-3/4 “x2-3/4” shall
be used. All bricks shall be chamber burnt and of first class quantity sound, hard, well burnt but
not over burnt, of regular uniform size, shapes and colour (generally deep red of copper)
homogeneous in texture and free from flaws and cracks. Bricks shall be of crushing strength of
not less than 70 Kg/Cm2.

1.3.8 GLAZING GLASS

Shall be of the best quality plain or ground glass, free from flaws, specks bubbles, of approved
make.

1.3.9 MOSAIC TILES

The tiles shall be between 20 to 25mm thickness and 250 x 250 mm and shall confirm to I.S.
1237-1957. The chips used shall be of approved colour and must be marble chips. The size of
the chips shall be 6 to 3 mm. The top layer of mosaic tiles shall not be less than 6mm thickness,
and must be permanent and fast to the action of light, alkali and weather and shall be
chemically inert and free from adulterants likely to cause chemical action on cement. The
weight of 250 x 250mm mosaic tiles shall be 3Kg per tile approximately.

1.3.10 STEEL WINDOWS AND DOORS

Shall be made from mild steel sections, free form roling defects. All steel doors and windows
shall confirm to IS: 1038 – 957 unless otherwise specified. Steel sections should be cold
straightened and such as to be easily punched and welded.

1.3.11 ALUMINUM WINDOWS, DOORS AND GLAZED PANELS

Shall be made from extruded Aluminum sections and shall be of approved manufacturers.

1.3.12 PAINTS

These shall be of standard manufacture conforming to the latest Indian Standards for various
paints.

1.3.13 TESTING OF MATERIALS AND WORKS

All the materials are to be tested as per the relevant ISI standards.

1.3.14 ANTI – TERMITE TREATMENT

Page 25 of 53
prevention of the termite from reaching the super-structure of the building and its contents can
be achieved by creating a chemical barrier between the ground from where the termites come
and other contents of the building which may form food for the termites. This is achieved by
treating the soil beneath the building and around the foundation with a suitable insecticide.

Concentration (%)
Dieldring emulsifiable concentrates (IS 1054 – 1962) 0.5
Aldrin emulsifiable concentrates (IS 1307 – 1958) 0.5
Heptachlor emulsifiable concentrates 0.5
Chlordane emulsifiable concentrates 1.0

1.4 DEFINITION OF FINISHES.

1.4.1 CEMENT CONCRETE FLOORING

Cement concrete flooring shall be laid in thickness and with cement concrete as specified in the
schedule of quantities laid in panels either made by fixing A.C. or glass – strips or any class of
strips as specified in the schedule of quantities or with wooden removable forms. Before laying
floor concrete, the sub-grade shall be properly cleaned, trimmed to give required thickness of
floor and neat cement slurry applied to give proper bond of floor with subgrade, the cement
concrete shall be laid and finished with trowels and finished with a coat of neat cement on top
to give a smooth and homogeneous surface. No extra mortar shall be laid over the concrete to
make the floor level or for drying the concrete for applying the cement slurry.

1.4.2 CEMENT PLASTER

The cement & fine sand shall be mixed in the ratio specified in the schedule of quantities.
While plastering RCC surfaces shall be roughened with steel chisels, cleaned of dust, washed
and kept wet prior to plastering.

1.4.3 20mm THICK SAND PLASTER

i) Scaffolding: Double scaffolding shall invariably be provided having two sets of vertical
supports.

ii) Preparation of surface: The surface shall be raked out, cleaned, washed and kept dried
before plastering is commenced.

iii) Mortar:

Under coat: This shall consist of cement mortar 1:2 (1 cement , coarse sand/stone dust/marble
chips of sizes) as mentioned in the schedule of quantities.

Top Coat: This shall consist of cement mortar 1:2 (1 Cement, 2 coarse sand dust/marble chips
of sizes) as mentioned in the schedule quantities
be added to white wash.

1.4.5 COLOUR WASH

Required Colouring pigment shall be added to the white wash. The primary coat shall be White
wash. The finished surface shall be of even tint. Any blotchy or bad surface shall be re – done.
Other specifications shall be the same as for white washing.
Page 26 of 53

1.4.6 DISTEMPERING

The distemper shall be mixed in clean water using ½ pint for 1b of distemper as per
manufacturer’s specifications and shall be stirred till the mixture attains an even consistency.

The surface shall be cleaned. All irregularities and inequalities shall be sand papered and wiped
clean to present a fine smooth surface and shall be completely dried before distempering is
started.

The mixture shall be applied with a brush in long parallel strokes evenly so as not to leave any
visible brush marks. The treated surface shall be allowed to dry and harden. Then the second
coat shall be applied on the first coat. If a uniform surface is not achieved then the 3 rd coat shall
be applied.

1.4.7 OIL BOUNDED DISTEMPERING

All plaster surfaces shall be thoroughly cleaned and shall receive 4 coats. First coat of premier
s\hall be applied after the primary coat of white lime is properly scrapped off. The second coat
and third shall be of oil bound distemper of approved colour shade.

1.4.8 EPOXY SELF LEVELLING 2mm THICK FLOOR TOPPING

The epoxy floor laid on a prepared substrate shall have good resistance to wide range of
chemicals. It shall be laid on an epoxy primed concrete surface.

1.4.9 EPOXY COVING

The application of a high strength epoxy screed at 0.3 mm tk. shall be on prepared cement
coving. It shall be applied on the surface primed with an epoxy primer. The top surface of the
coving shall be applied with epoxy putty, for making necessary surface preparation, and floor
coating shall be extended.

1.4.10 PVC FLOORING

Vinyl flooring material is normally used for covering floor from cleanliness point of view in
clean room areas. This material gives a resilient and non-porous surface, which can be easily
cleaned with wet mop, as dust and grime do not penetrate the surface.

It shall be laid on a base that is finished even and smooth such as concrete. Normally vacuum
dewatered floor is recommended incase the area is in ground floor to avoid damage to the vinyl
tiles by moisture ingress. Vinyl tiles finish depends on the floor evenness and will follow the
same contour of the base floor.

The Vinyl flooring material shall confirm to IS: 3462. It may be in the form of Tiles or rolls as
specified. It shall consist a thoroughly bended composition of the thermoplastic binder, filler
and pigments. The thermoplastic binder shall consist substantially of one or both of the
following:

a) Vinyl Chloride Polymer

b) Vinyl Chloride Copolymer
Page 27 of 53
The polymeric material shall be compounded with suitable plasticizers and stabilizers. The
special composition and structure of the tiles ensure a permanent protection against Electro
Static Discharge.

The preferred thickness of Vinyl tiles for the normal floor covering shall be 2 and 3 mm for
Static dissipative and Static dissipative industrial floors respectively and 2.0mm for
Electrostatic conductive floor.

Rubber based or PVA based adhesives shall be used for fixing PVC flooring over concrete.

1.4.11 Properties of PVC flooring materials

S. Description Static Dissipative Static Dissipative Electrostatic

No floor Industrial Floor conductive floor
1 Thickness 2 3 2
(in mm)
2 Dimensional Length wise / cross Length wise / cross Length wise / cross
stability wise 0.05% wise 0.05% wise 0.05%
3 Residual 0.035 mm exceeds 0.035 mm exceeds 0.035 mm exceeds
identation 1500 Pounds/sqi 1500 Pounds/sqi 1500 Pounds/sqi
4 Wear Resistance 0.17 mm 0.17 mm 0.17 mm
5 Fire resistance Difficult to ignite Difficult to ignite Difficult to ignite /low
/low smoke /low smoke smoke development
development development
6 Heat resistance 0.011M2 K/W 0.016M2 K/W 0.011M2 K/W
7 Resistance to Offers good Offers good Offers good resistance
chemicals resistance to acids, resistance to acids, to acids, alkalies, oils,
alkalies, oils, petrol, alkalies, oils, petrol, petrol, alchol, and
alchol, and white alchol, and white white sprit.
sprit. sprit. When applied for
When applied for When applied for longer periods (>24
longer periods (>24 longer periods (>24 Hrs) less resistance to
Hrs) less Hrs) less resistance certain other solvents
Resistance to to certain other such as aromatics
certain other solvents such as (Brnzene, Toulene),
solvents such as aromatics Ester (Ethyl Acetate),
aromatics (benzene, (Benzene, Toulene), Ketones (Acetones)
Toulene), esters ester (ethyl acetate), and Chlorinated
(ethyl acetate), Ketones (Acetones) Hydrocarbons
Ketones (acetone) and Chlorinated
and Chlorinated hydrocarbons
hydrocarbons
8 Ease of Excellent Excellent Excellent
decontamination

ANTI – TERMITE TREATMENT shall in general be in accordance with IS 6313, code of

practice for anti-termite measures in buildings. The chemical used shall be chloropyrifos20 %
EC dilution of 1 part with 19 parts of water.

Chemicals shall be brought to site in sealed original containers.

Page 28 of 53
A pressure pump shall be used for uniform spraying of the chemical. To have proper check,
graduated containers shall be used.

Soil treatment should start when foundation is ready to take mass concrete Laying of mass
concrete should start when the chemical emulsion has been absorbed by the soil and the surface
is dry. Treatment should not be carried out when the soil is wet with rain or sub-soil water.

The bottom surface and sides (Up to a height of 300 mm) of the excavation made for masonry
foundations and basements shall be treated with chemical at the rate 5 Liters per Sq.M of the
surface area.

After the masonry foundations and the retaining walls of the basement come up, the back fill in
immediate contact with the foundation structures shall be treated at the rate of 7.5 Liters per
Sq.M of the vertical surface of the sub-structure for each side.

In the case of R.C.C foundations, the treatment shall start at the depth of 500 mm below ground
level. From this depth, the back fill around columns, beams, and R.C.C foundations shall be
treated at the rate of 7.5 Liters per sq.m of the vertical surface.

The top surface of the filled earth with in plinth walls shall be treated with chemical emulsion
at the rate of 5 Liters per sq.m of the surface befor the sand / sub grade is laid.

To achieve continuity of the vertical chemical barrier on inner wall surfaces from the ground
level, small channel 30 x 30 mm shall be made a the junction of the wall and columns with the
floor and red holes made in the channel and the chemical emulsion poured along the channel at
the rate of 7.5 Liters per sq.m of the vertical wall or column surface.

After the building is complete, the chemical emulsion at the rate of 7.5 Liters / sq.m of the
vertical surfaces shall be filled providing holes in the soil at 15 cm intervals.

Treatment shall also be supplemented when pipes conduits enter the soil inside the area of
foundation.

When pipes, drains and conduits enter the soil inside the area of the foundation, the soil
surrounding the point of entry must be loosened around each such pipe, drain or conduit and
treated with chemical emulsion at the rate of 1 Liter per linear meter to create a chemical
barrier
3

Sno
Stair cases

Ware houses

Ceramic tiles
Kota stone /

Flooring
 The drier outlet room, Powder processing area and packing area are connected to a single

------------- and ------------- finished goods storage areas are connected to two different
Walls Ceilings Painting Coving Doors
Masonry brick Masonry block, Masonry concrete, Polyurethane Polyurethane No coving MS/GI Powder
walls internal facing of gypsum board, coated
exterior insulated FRP or Steel
finish systems panels
(E.I.F.S) and fiber
glass
VDF floor Masonry brick Masonry block, Masonry block, Acrylic / Acrylic / MS/GI Powder
with admix work internal facing of concrete gypsum Enamel Enamel coated

The AHU zoning in HVAC is done on the following guide lines.

exterior insulated board
finish systems

AHU each for ------------- and ---------------- Products.

(E.I.F.S.) and fiber

AHU’s to maintain different temperature conditions.

glass
Kota stone Masonry block, Masonry block, MS/GI Powder
concrete, gypsum internal facing of coated
board exterior insulated
finish systems
(E.I.F.S.) and fiber
glass

44 th Page Pending
MS/GI Powder
coated
Page 29 of 53

1.

2.
Page 30 of 53

3. Raw material recipt area, Quarantine, Rejected material stores, Ware house office, Raw
material Sampling and Dispensing areas are connected to a single AHU.

4. Crystallizer, Drier area and wash area are connected to separate AHU each for -------------
and ------------- Prod

5. Personal and Material access corridors are connected to separate AHU each for
------------- and ------------- Prod.

6. Powder charging areas are connected to individual AHUs for both ------------- and
------------- Prod.

7. Change rooms and surrounding corridors are connected to a single AHU.

8. Technical areas (of both ------------- and ------------- Prod ) are connected to individual
AHU’s.

The following legends are used in this concept

AHU denotes Air Handling Unit

TI denotes With terminal HEPA
TII denotes With terminal 5 Micron filter
TIII denotes With Plenum 5 micron filter
PA denotes Paracetamol block
ME denotes Metformin HCl block
WH denotes Ware House
AD denotes Amenties
XX denotes AHU no. for the department
XXX denotes Cumulative AHU no.

The concept note for t I type AHU Is as follows :

1 T I type AHU

This AHU contains 20 micron filter in fresh air, 10 and 5 micron filters in AHU, terminal
HEPA filter, 20 micron filter in return air.

The return air, from rooms, mixes with fresh air in the mixing box and passes over 10 micron
Pre filter, Cooling coil, Mist eliminator (to remove the condensate from the air), & Heating coil
(for necessary reheating of air depending upon the RH requirement). It then mixes with the
bypass air in the mixing section, after the heating coil section. This air is drawn by the blower
and is discharged to the connected areas through the microvee filter (5 micron) section through
perforated sheet to get a uniform distribution through out the filter bank and a terminal HEPA
filter.

The HEPA filters are located in the inlet to the individual rooms. The HEPA filter is housed in
the filter box, which is accessible from the process room.

The air gets distributed in the room and then passes to the return air duct through return air
raises i.e; Bottom extract. The return air extracts are located at a height of 15o mm from floor
Page 31 of 53
level, in the walls. A 20 micron filter is provided in the return air riser to have a pre filtration in
the starting of the return air stream to avoid the powdewr accumulation in the ducts.

A Fire sensor is provided in the return air duct.

A predetermined quantity of air is vented out and is connected to common exhaust section, for
each module, from the return air duct. The amount of air getting vented is dependent on the
room leakages and pressure gradient across the rooms which was mentioned in the attached air
flow diagrams for the individual AHUs.

Minimum of 10 % of the fresh air will be added in the mixing section before it passes through
cooling coil.

The blower shall be designed to supply not less than 40 air changes / hour in the rooms.

Controls:

1. A DP Switch id provided across the microvee filter section in the supply air stream to
monitor the pressure difference across the five micron filter section. Two set points have
been provided for setting Operating and Alert levels.

2. A provision is made in the Filter box to check the integrity of the HEPA filters, to be
tested periodically by passing DOP aerosol.

3. The fire damper in return air duct of AHU shall close immediately, on signal from fire
alarm sensor.

4. The AHU shall also trip on fire signal from fire alarm sensor.

5. Air flow switch will give run status of AHU fan. It will give alarm when motor is running
and there is no air flow and trips Fan motor.

6. Two way control valve on chilled water line will open only after Air flow switch is “ON”
with time lag i.e.; after the air flow is established.

7. Two way control valve on chilled water line shall be controlled by return RH sensor and
temperature sensor after coil (for ADP), which ever activates first.

8. The two way control valve on Hot water line shall be controlled by the return air
temperature.

9. The room pressure gradient and room temperature will be displayed in the critical process
rooms

10. VED of AHU fan motor shall vary the speed of the motor based on the supply air flow
transmitter’s signals to maintain constant air flow to the rooms compensating the increase
in pressure drop across Supply air & Return air filters.

11. List of AHUs (AHU Numbers)

-------------------------------------
-------------------------------------
-------------------------------------
-------------------------------------
Page 32 of 53
-------------------------------------
4. Air flow switch will give run status of AHU fan. It will give alarm when motor is running
and there is no Air flow and trips Fan motor.

5. The room pressure gradient will be displayed in the critical process rooms.

List of AHUs (AHU Numbers)

-------------------------------------
-------------------------------------
-------------------------------------
-------------------------------------
-------------------------------------

The pressure differentials in HVAC system are maintained on the following guidelines:

1. In Technical manufacturing areas :

 All the manufacturing rooms will be negative to corridor.

 PAP changing room is negative to adjacent areas.

 Personal change room to PAP will be negative to the adjacent area.

2. In Pharma areas

 All areas are negative to the clean corridor.

 FG Quarantine area will be Negative to packing rooms

 PM area is negative to the packing hall.

3. In ware house area

 Dispensing area will be Negative to surrounding areas.

 Raw material ware house and FG warehouse will be Positive to atmosphere.

 Finished goods area (------------------------------) and primary packing material storage

area are positive to the adjacent areas.

4. All the above pressure differences are indicated with following denotations.

Denotation Room static Pressure

(+) : 0.5 to 1.5 mm of Wg.
(++) : 2.0 to 3.0 mm of Wg
(+++) : 3.5 to 4.5 mm of Wg
(++++) : 5.0 to 6.0 mm of Wg
 Page 33 of 53

S. Particulars Details
No
1 ELECTRIC POWER LICENCEE ANDHRAPRADESH ELECTRICITY BOARD
2 SUPPLY SYSTEM 11 KV, 3PH, 50 HZ
3 VARIATION
-VOLTAGE 415  10 %
-FREQUENCY 50 HZ  5 %
4 ELECTRICAL LOAD AS PER ELECTRICAL LOAD LIST
TOTAL LOAD 1400 KW
5 POWER DISTRIBUTION

A) SCHEME

OUT DOOR INSTALLATION

B) (NEAR PLOT BOUNDARY)

(a) INCOMING FEEDER BY APSEB

-LINE DETAILS 1 NO. 11 KV, 500 MVA OVER HEAD HT LINE.
-ISOLATION
(a) MANUAL OF LOAD GANG OPERATED DEVICE
(GOD) VERTICAL ISOLATOR
(b) FAULT ISOLATION HORN GAP FUSES
METERING CLASS 1.0 CT AND PT UNITS
(b) INCOMING ISOLATION
BY CUSTOMER (OHC)
i) OUT DOOR SWITCH YARD GANG OPERATING DEVICE (G.O.D)
WITH HORN GAP FUSES.
ii) INDOOR SUBSTATION FLOOR MOUNTED CUBICLE, 11 KV SF6
BREAKER

(C) TRANSFORMER 1 NO. 11 KV /433 V, 1600 KVA

C HV CONNECTION
D LV INSULATION
E LV CONNECTION
OUT DOOR TYPE WITH ONLOAD TAP
CHANGER, ON AIR COOLED, DOBLE
WOUND COPPER WINDING
(ON LOAD TAPPING RANGE – 15 % TO + 5%
IN STEPS OF 1.25%), 50 HZ,
DYN – 11, Z = 6.25 % & WITH
HV CABLE BOX, LV BUS DUCT
THROUGH HV, XLPE, AL
CABLE SUITABLE TO WITH – STAND THE
FAULT LEVEL CURRENT ENCOUNTERED IN
THE AREA OF THE INSTALLATION FOR 1
SECOND.
LV 3600 AMPS BREAKER PANEL
() A BUSDUCT WITH ALUMINUM
BUSBARS (TPN)
PAINTING: INTERIOR - BLACK
: EXTERIOR - LIGHTGREY
 Page 34 of 53
F MAIN L.T. SWITCH
BOARD (MLSB) COMPARTMENTALISED SHEET STEEL
(CRA) FLOOR MOUNTED FREE
STANDING CUBICLE, USING DRAW OUT TYPE
ACB AS INCOMER AND OUT GOING – SWITCH
FUSE UNITS (FIXED TYPE)/
CIRCUIT BREAKERS (DRAW OUT TYPE)
BOARD IS WITH DOUBLE BUS BAR
ARRANGEMENT – ONE FOR APSEB AND ONE
FOR DG.
CABLE ENTRY WILL BE FROM BOTTOM.
FACILITY WILL BE PROVIDED TO MOUNT
LOAD
MANAGERS ON INCOMERS IN FUTURE. FO
ALL OUT GOING FEEDERS, CTS SHALL BE
PROVIDED WITH PROVISON FOR FIXING
LOAD MANAGER IN FUTURE
G BUS BARS ELECTROLYTIC GRADE COPPER DOUBLE
BUSBAR SYSTEM WITH HEAT SHRINKABLE
TYPE COLOR CODED PVC
SLEEVES AND SMC BUSBAR SUPPORTS.

H MOTOR CONTROL FIXED COMPARTAMENTALISED SHEET

STEEL (CRCA) FLOOR MOUNTED, FREE
CENTERS (MCC) STANDING SWITCH BOARD.
CABLE ENTRY WILL BE FROM TOP.
ALL MCCs ARE LOCATED IN THE SERVIECE
FLOOR OF THE PROCUCTION UILDING.
MOTOR TERMINAL VOLTAGE – 415  10 %
FREQUENCY 50 HZ  5 %
FOR MOTOR STARTERS. MPCBs WITH
OVERCURRENT AND SHORT CIRCUIT
FEATURES WILL BE USED. ALL COMPONENTS
ON STARTERS WILL BE WITHTYPE – 2
COORDINATION
+

J LIGHTING PANELS MCB OPERATED, WALL / STRUCTURE

MOUNTED CUBICLES, INCOMERS WITH MCB +
RCCB. O/G WITH MCB (DP) AND CONTACTORS
WHERE EVER APPLICABLE
ELECTRONIC TYPE ENERGY METER WILL BE
PROVIDED IN THE INCOMER OF LIGHTING
FEEDER
 Page 35 of 53
6 POWER FACTOR
7 AREA CLASSIFICATION
AN UNCOMPENSATED PF OF 0.80 WILL BE
IMPROVED TO 0.98 USING PF IMPROVEMENT
CAPACITORS CONNECTED TO MAIN LT
SWITCH BOARD, OF 100 KVAR CAPACITY. 50 %
OF THE CAPACITORS WILL BE PERMANENTLY
IN CIRCUIT AND THE BALANCE 50 % WILL
CONTROLLED USING AUTOMATIC PF
CORRECTION RELAY / CONTROL.CAPACITORS
WILL BE OF MIXED DIELECTRIC DESIGN
NON HAZARDOUS (SAFE AREA)

TANK FARM AND -------------------------

MANUFACTURING AREA ARE CLASSIFIED AS
HAZARDOUS AREAS. (ZONE II, GROUP IIA / II B,
TEMP CL. T4.) FLP MOTORS, LIGHTING AND
ENCLOSURES SHALL BE CONSIDERED FOR
THESE AREAS.

8 EARTHING - EARTHING PIT WITH COPPER PIPE / TREATED

ELECTRODE

- MAIN EQUIPMENT EARTHING WITH

PREINSULATED COPPER CABLE.

- TRANSFORMED NEUTRAL EARTHING WITH 2

Nos. COPER PLATE ELECTRODE / STRIP

- EARTHING WILL BE CARRIED OUT, AS PER IS

3043 USING COPPER WIRE OF SIZE AS
GOVERNED BY THE ABOVE STANDARD.

- EQUIPMENT EASRTHING AND DIVE

EARTHING WILL BE SEPARATE.

9 LIGHTING AREA LUX LEVEL TYPE OF FITTINGS

A) MANUFACTURING 400 AROUND 3 X 36 WATTS FLOURESCENT TUBE CLEAN
AREA EQPT. ROOM LIGHTING FITTINGS
MAINTAINABLE FROM – TOP.
TO BE INSTALLED IN THE ROOF SLAB.
B) LABORATORIES 400 AROUND 3 X 36 WATTS FLOURESCENT TUBE CLEAN
AND WRITE UP EQPT. ROOM LIGHTING FITTINGS
AREA
C) MANUFACTURING 300 IN 3 X 36 WATTS FLOURESCENT TUBE CLEAN
AND PACKING OPERATION ROOM LIGHTING FITTINGS
AREA CORRIDORS AREAS
D) WAREHOUSE 250 IN 400 W METAL HALIDE MEDIUM BAY
OPERATION FITTINGS
AREA
E) SERVICE FLOOR 250 IN 250 W METAL HALIDE MEDIUM BAY
OPERATION FITTINGS
 Page 36 of 53
AREA
F) TYPE OF CHOKES FOR
FLUOROSCENT FITTINGS
G) AUTOMATIC CONTROL OF LIGHT
H) TYPE OF TRANSFORMER (IF
REQUIRED) USED FOR LIGHTING
SYSTEM
10 A WIRING
- TYPE OF CABLE
- POWER WIRING
- CONTROL WIRING
- LIGHTING WIRING
a) PLANT AREAS /
SUBSTATION / ETP / UTILITY
ETC.
b) STREET / ROAD / YARD
B CABLE TERMINATION
11 STREET / FLOOD / LIGHT POLES
ELECTRONIC BELLAST / COPPER
BALLAST
WILL BE PROVIDED IN :
i) CHANGE ROOM
DRY TYPE
650V/1100V GRADE ARMOURED PVC
CABLE
COPPER CONDUCTOR ARMOURED CABLE
WILL BE USED FOR SIZES UPTO 6 SW.MM..
FROM 16 SQ.MM AND ABOVE, ALUMINUM
CONDUCTOR ARMOURED CABLEWILL BE
USED. HOWEVER, COPPER CABLES WILL
BE USED WHERE LARGE NUMBER OF
BENDS IS INVOLVED.
CABLE IZE WILL BE SELECTED TO SUIT
VOLTAGE DROP OF 2 % OF 415 V FROM
MCC TO DRIVE
3 % OF 415 V FROM MLSB TO MCC. MIN
IMUM SIZE OF POWER CABLE WILL BE 2.5
SQ.MM COPPER
WITH COPPER CONDUCTOR (MIN. 1.5
SQ.MM) ARMOURED CABLE
WITH 3 C, 2.5 SQ. MM YWY CABLE /
SURFACE GI CONDUCT, WITH 2.5 SQ. MM
COPPER WIRES.
WITH 4 C X 16 SQ.MM AYFY CABLE.
WITH DOUBLE COMPRESSION – FOR
ERQUIPMENT
WITH SINGLE COMPRESSION – FOR
OTHERS TYPE CABLE GLANDS
10.3 MTR. HEIGHT (8.3 ABOVE FINISHED.
ROAD LEVEL) SWAGED TYPE POLE.
a) STRAIGHT FOR FLOOD LIGHT
b) CURVED FOR STREET LIGHT.
 Page 37 of 53
12 EMERGENCY LIGHTING SYSTEM EMERGENCY LIGHTING FITTING WILL BE
PROVIDED IN CRITICAL PRODUCTION
ROOMS AND OTHER OPERATIONAL
AREAS WITH BATTERY BACK-UP.
BATTERY BACK-UP TIME WILL BE 30
MINUTES.
13 EMERGENCY D.G. SET WILL BE PROVIDED TO MEET THE POWER
REQUIREMENTS DURING PERIODS OF
POWER SUPPLY INTERRUPTION.
DOUBLE BUSBAR SYSTEM WILL BE
ADOPTED TO ENSURE FLEXIBILITY IN
CHOOSING ANY GROUP OF LOADS ON
D.G. SET

LOADING OF DG WILL BE CONTROLLED

MANUALLY.
DG SET WILL HAVE AMF FACILITY TO
ENSURE AVAILABILITY OF STANDBY
POWER WITH MINIMUM INTERRUPTION
OF POWER SUPPLY.
14 BATTERY & BATTERY CHARGER SEALED MAINTENANCE AND FREE LEAD
ACID TYPE 24 V BATTERY TO SUIT ‘AH’
REQUIREMENT AS PER SYSTEM.
15 CODES & STANDARDS IE RULES
RELEVANT ‘IS’ AND LOCAL STATUTARY
REQUIREMENT.
16 CABLE LAYING CABLE WILL BE LAID ON GI LADDER
TYPE PREFABRICATED CABLE TRAYS.
CABLES FROM SUBSTATION WILL BE
TAKEN OUT THROUGH TRENCHES.
PROPER SEALING ARRNGEMENT AND
DEWATERING FACILITY WILL BE
PROVIDED IN SUBSTATION / PRODUCTION
FACILITIES WHERE THE CABLES ENTER
THE BUILDING.
17 SOCKET OUTLET (3 PHASE) SAFE AREAS WILL BE PROVIDED WITH
SOCKETS SUITABLE FOR CLEAN ROOM
APPLICATION & FOR HAZARDOUS AREA,
FLAME PROOF SOCKETS WILL BE
PROVIDED.
18 EXIT SIGN BOARD PHOTO LUMINISCENT TYPE O BE
PROVIDED.
19 INSECT KILLER TO BE PROVIDED WHREEVE NEEDED.
20 AIRLOCK / DOOR INTERLOCKING TO BE PROVIDED FOR DOORS IDENTIFIED
21 TELEPHONE & COMPUTER WILL BE PROVIDED IN THE ROOMS
SYSTEM IDENTIFIED.
 Page 38 of 53

TECHNICAL SPECIFICATION OF CLEAN ROOM LIGHT FITTINGS

1.0 Design requirements:

1.1 General:

1.1.1 The luminary should withstand repeated cleaning of water, detergent and common
disinfecting materials used in the Pharmaceutical Industry.

1.1.2 The fitting shall be with top opening or Bottom opening to enable maintenance to be done
from the service from the service floor or from ground floor.

1.1.3 The luminaries shall be totally enclosed while maintaining the thermal cycling necessary for
enhancing the life of the control gear.

1.1.4 The material of construction shall be non-corrosive in nature. Suitable surface treatment shall
be done to prevent oxidation. Powder coating of the fitting is recommended.

1.1.5 Packing materials like gaskets shall be non-hygroscopic and shall not support mould growth.
XLPE. EPDM are the approved materials for this purpose.

1.1.6 The design shall ensure minimum horizontal areas to minimize settling of dust particles on
the fitting.

1.1.7 The luminaries shall have a One way switch to control the power to the lightings.

1.1.8 The luminaries shall be of Flame Proof construction for the --------------------------
manufacturing and Tank farm areas.

1.2 TOP OPENING CLEAN LUMINAIRE

1.2.1 The lamp and control gear shall be accessible from the top of the luminaries, i.e., from the
service floor.

1.2.2 The design shall be of recess mounting type.

1.2.3 The luminaries shall consist of precisely manufactured bottom frame cum housing The
housing cover, reflector & control gear tray shall be white and powder coated. The surface
shall be scratch resistant.

1.2.4 A clear acrylic diffuser shall be sealed with the bottom frame by non-hygroscopic gaskets to
ensure dust proofing. The diffuser shall be non-yellowing, long lasting and ensure high light
transmittance.

1.2.5 The ballast shall be mounted on removable gear tray and shall be pre-wired up to the terminal
block. The complete control gear shall be mounted on a removable tray to enable easier
maintenance. The mounting arrangement shall ensure faster installation / maintenance.

1.2.6 Starters shall be easily accessible for faster replacement when required.
 Page 39 of 53

1.2.7 The fitting shall be provided with a pre-anodized reflector of high purity aluminum to ensure
excellent light distribution.

1.2.8 The fitting shall be supplied with a top frame / cover with suitable gaskets to prevent settling
of dust on top surface of the fitting.

1.2.9 The general construction shall be user-friendly and shall enable the maintenance of the fitting
by one person.

1.3 BOTTOM OPENING LUMANIARE

1.3.1 Luminaries shall comprise of a bottom frame, CRCA housing, reflector & Control gear tray
duly powder coated white. The surface shall be scratch resistant.

1.3.2 Bottom frame shall be fixed with captive screws without any of the fastening components
projecting from the surface and hampering the cleaning of the fitting.

1.3.3 A clear acrylic diffuser shall be sealed to the bottom frame with non-aging and chemically
inactive rubber gasket.

1.3.4 The ballast shall mounted on a removable gear tray and pre-wired up to the terminal block.

1.3.5 A high purity aluminum reflector shall form part of supply.

1.4 LAMPS

1.4.1 Lamps shall be Fluorescent / compact type.

1.4.2 Fluorescent lamps shall be of ‘LUMILUX’ or equivalent type and shall have a lumens output
of 3250 or higher. Further the lamp shall have a very high color-rendering index.

1.4.3 Compact Fluorescent lamps shall have high luminous efficacies, long life, low power
consumption and a good color rendering properties.

1.5 BALLASTS

1.5.1 The ballast shall be energy efficient, low loss type.

1.5.2 The fitting shall be supplied with electronic ballast. The design shall be with IC based
technology and shall include an out put control electronic circuit. Further the design shall
ensure energy saving, longer life and good out put light quality. The ballast shall ensure
highest safety and reliability.
 Page 40 of 53

2.0 TYPE OF FITTING USED

Type of fitting used Area

Top opening, clean room fitting with All manufacturing areas including clean
fluorescent lamps maintainable from service circulation corridors.
floor

Bottom opening, clean room fitting with Change rooms

fluorescent lamps

Non-Integral metal halide fitting Ware house

 Page 41 of 53

1.0 AREA CLASSIFICATION

Hazardous in the following:

i) -------------------------Manufacturing area.

ii) Diesel oil and Furnace oil storage area.

1.1 PIPE MATERIAL CLASSIFICATION

S. Service Max Base Piping class Valve Insulati

No Press. Op. piping ANSI Spec Type on Type
Kg/Cm2 Temp Material Range
(g) C
1 Raw Water 6 Amb. CS 150 # A1a B,G,GL, -
C,BF

2 Filter Water (FW)/ 6 Amb. CS/GL/ 150 # A1d/ B,G,GL, -

Process Water (PW) SS-304 A1e/ C,BF
A2a

3 Purified Water 10 90 SS-316L Triclover A2d B,C,D Sterile

(USP) (Refer Note) Electro- Fitting Service
Polished Hot Ins.

4 D.M. Water (DMW) 6 Amb SS304 150 # A2a B,G,GL,

C,D
5 Cooling Water (CW) 6 40 CS 150 # A1a B,G,L,C
,BF
6 Chilled Water 6 7to20 CS 150 # A1d B,G,GL, Cold
(CHW) C,BF Ins.

7 Chilled Brine (CHB) 6 -20 to CS 150 # A1d B,G,GL, Cold

0 C,BF Ins.

8 Comp. Air (CA)/ 8 45 GI/SS-304 150 # A1e/ B,G,GL,

Inst. Air (IA) A2a C

9 Process Fluid (P) 5 Amb SS316 / 150 # / A2b B,G,GL,

SS316L Triclover C
Fitting

10 Hot Water (HW) 6 95 SS-304 150 # A2a B,G,GL, Hot Ins.

C
 Page 42 of 53

S. Service Max Base Piping class Valve Insulati

No Press. Op. piping ANSI Spec Type on Type
Kg/Cm2 Temp Material Range
(g) C
11 High Pr. Steam / 10.5 200 CS/SS304 300 # A1c GL,C,P, Hot Ins.
High Pr. Condensate G
(HPS/HPC)

12 Medium Pr. Steam/ 8.0 175 CS/SS304 150 # A1c GL,C,P, Hot Ins.
Medium Pressure G
condensate
(MPS/MPC)

13 Low Pr. Steam/Low 3.5 145 CS/SS304 150 # A1d/ G,GL,P, Hot Ins.
Pr. Condensate A2a C
(LPS/LPC)

14 Furnace Oil (FO) 4 Amb- CS 150 # A1d G,GL,C Hot Ins.

70

15 Diesel (HSD) 4 Amb. CS 150 # A1d G,GL,C

16 Powder Transfer SS316/ Triclover A2d C,D Nil.

SS316L EP Fitting

LEGEND:

B – Ball Valve BF – Butterfly Valve G – Globe Valve P – Piston Valve

G – Gate Valve D – Diaphragm Valve C – Check valve

Note: USP SHALL BE O.D BASED

2.0 DESIGN CRITERIA:

2.1 All pipe work will be routed to effect the shortest path (with out infringing 4.3) thus eliminating
excessive or complex runs and reducing to the minimum number of fittings.

2.2 In the plant Buildings utility headers shall run on service floor & sub-headers over Technical
space. The utility headers from utility block to -----------------------&-----------------------------
blocks shall be on pipe rock.

2.3 As far as possible, pipe work will be routed parallel or at right angles to the building lines.

2.3a For Non-plant buildings, pipe work will be routed suitably in consultation with client.

2.4 The purified Water to Pharma equipments shall be of SS 316L, seamless tubes, electro polished
inside 320 grit & out side 180grit finish. All weld joints shall be with orbital welding with
100 % record, 100% Boroscopy, ground & polished. Tubes to be passivated after welding.
Zero dead lag valves with sanitary construction to be considered.
 Page 43 of 53

2.5 Purified water joints shall be through Triclover joints. Specification break for all other utilities
shall be through flanged joints and in production area to SS – 304 materials.

2.6 Individual utility tapping to rooms shall be from Utility Headers/Sub headers to elevation as per
machine connection requirement from the technical space provided.

Utility tapings to rooms wherever technical space has not been provided shall be through the
wall/partition wall of individual rooms. In exceptional cases wherever wall/partition wall has
not been provided utility tappings shall be through SS service console installed at a
convenient location depending upon pharma machinery location. Final connection to be
through flexible hose as per pharma machine supplier connection type.

2.7 Suitably braided hose shall be used for air, filtered water wherever required that are not used
directly either in the production of for washing & cleaning of product vessels, tanks etc.

2.8 Inner PTFE (Food Graded) smooth tube for steam / USP Water & PVC Nylon braided for
Air/FW, reinforced with single braid SS 304 steel wire flexible hose shall be used for utilities
that are used directly in production for washing & Cleaning of product vessels, tanks, etc.

2.9 No asbestos containing material shall be used in any form in the plant.

2.10 Pipe supports in production area are of SS, electro-polished to 180 grit finish.

2.11 DESCRIPTION FOR PIPING OUTSIDE PRODUCTION AREA

Piping class Detail

(Service)
A1a : A1a – ERW, CS
(RW, CW) Pipe Type : A1c – SMLS, CS (IBR)
: A1d – SMLS, CS
A1c Pipe to pipe joint : 40 NB & Below; Socket welded
(HPS, HPC, MPS, : 50 NB & Above; But Welded
MPC)

A1d Flange Type : 40 NB & Below; Socket Welded

(FW, CHW, CHB, : Raised face (SWRF), C.S.
FO)
PW, HSD, LPS, LPC 50 NB & Above slip on raised face
(SORF) C.S.

Gasket : PTFE
A1e Pipe Type : CS, GI
(FW, PW, CA, IA) Pipe to Pipe joint : Threaded coupling

Flange type : Threaded RF

Gasket : PTFE

A2a Pipe type : SMLS, SS304

 Page 44 of 53

(FW, DMW, HW, Pipe to pipe joint : Butt welded

LPS, PW, LPC, CA,
IA)

Flange type : Weld neck Raised Face (WNRF),

SS304
Gasket PTFE

A2b Pipe type : SMLS, SS 316

(Process)
Pipe to pipe joint : But welded

Flange Type : Welded neck Raised Face (WNRF),

SS 316

Gasket : PTFE
A2d
Purified Water Pipe type : SMLS, SS 316 L, Electro-polished Tube

Pipe to pipe joint : Orbital Welding

(Tubes)

Jointing : Triclover clamp fittings

Gasket : Virgin PTFE

3.0 GENERAL PAINTING AND INSULATION SPECIFICATION

3.1 Painting

As the plant being setup in normal Industrial Environment at Hyderabad, following Painting System
is proposed:-

Surface Preparation - Manual / Mechanical

Primer - 2 Coats of Zinc Chromate Primer
Finish coat - 2 Coats of epoxy paint
Total DFT - 100 Microns (Min.)
Color coding - BS 1710 (1991)/IS 2379 (1990)

3.2 Insulation

3.2.1 Hot Insulation

Insulation material shall be resin bonded mineral wool (fire retardant wuality) performed pipe
section in 2 halves conforming to IS 8183 at a max. bulk density of 120-160 Kg/m3.

Preference shall be given to rock wool.

Carbon and alloy steel piping operating at high temperatures shall be protected against
corrosion by painting with a Zinc chromate primer suitable for that temperature.
 Page 45 of 53

Primer coat will not be applied on S.S. and other non-ferrous alloy piping but 0.1 mm
aluminum foil shall be wrapped around it before application of insulation.

3.2.2 Cold Insulation

Indoor Services

All materials used for Insulation, fixing and protection shall conform to the details given
below

All Insulating materials shall be non-corrosive to the surface insulated. Insulation material
shall be Elastomeric nitrile rubber foam with min. bulk density 50 Kg/m 3 for temperature
from –40C to 105C.

The material used shall not disintegrate, settle, change its form of composition, in a
determinal way, at the service conditions.

The insulating material shall be chemically inert, moisture free, rot and vermin proof.

Performed half sections and slabs shall be provided with their longitudinal and
circumferential faces flat and smooth xo as to mate with the mating sections of the whole
face area. Ends of the performed half sections shall be flat and perpendicular to the
centerline.

A primary coat of Zinc Chromate will be applied on all carbon steel and alloy steel piping,
before application of cold insulation. S. S. and non-ferrous alloys shall not be painted but
shall be wraped with 0.1 mm aluminum foil, before application of cold insulation.

Outdoor services

All materials used for insulation, fixing, sealing and protection shall confirm to the details
given below. All insulating materials shall non-corrosive to the surface insulated. Insulated
material shall be rigid preformed cellular polyurethane foam of self extinguishing type, in
accordance with ASTM C 591, Type II Grade 2.

Dimensions of perforated sections for piping insulation shall be defined by the outside
diameter and insulation thickness. Tolerances for preformed sections shall be as under

Out side Diameter +/- 3 mm

Concentricity +/- 3 mm

Bore +/- 2 mm

Length, Width and thickness +/- 2 mm

The material used shall not disintegrate, settle, change its form of composition, in a
determinal way, at the service conditions.

The insulating material shall be chemically inert, moisture free, rot and vermin proof.
 Page 46 of 53
Performed half sections and slabs shall be provided with their longitudinal and
circumferential faces flat and smooth so as to mate with the mating sections of the whole face
area. Ends of the performed half sections shall be flat and perpendicular to the center line.

A primer coat of Zinc Chromate will be applied on carbon steel and alloy steel piping, before
application of cold insulation. S.S and non-ferrous alloys shall not be painted but shall have
wrapped with 0.1 mm aluminum foil, before application of cold insulation.

The density of finished foam shall be with 36.0 Kg/cubic metre and shall be determined in
accordance with ASTM C-302. Compression strength min. 1.75 Kg f/centimeter square.

Joint Sealer to be used for sealing Polyurethane insulation joints and at flashing of insulation
shall be Foster Foam Seal Sealer 30-45

A complete vapor seal shall be provided over the insulation by a continuous vapor barrier
jacket or coating.

Aluminum cladding will be used as a weather protection over the insulation.

4.0 APPLICABLE STATUTORY REQUIREMENTS AND CODES/STDS.

1 ANSI B 31.3 Chemical plant And Petroleum Refinery Piping.

2 Factory Inspectorate / CGMP as per Rules and Regulations/Current Good manufacturing

USFDA Practices as per Food & Drug Administration (U.S)

3 Dimensional Stds. ANSI/BS/IS/ Manufacturer’s Std.

4 Material Specifications ASTM/BS/IS

5 Steam and condensate line As per IBR.

This concept gives guidance on the GMP requirements for Process, Process support and Utility
systems based on the concepts of product exposure, level of protection, and critical parameters and
systems.

 Process systems are systems which are:

- In contact with the drug substance in its purified or unpurified state.
- In contact with materials which ultimately will become, or be in contact with, a drug
substance
- In contact with a surface which will come into contact with the product.

 Process support systems are systems which directly support the process operations. These
systems do not come into contact with the drug substance, but affect process operations,
such as heating, cooling or vacuum, or they deal with side effect of the process, such as
an air emission or a waste liquid.

 Utility systems do not come into contact with drug substance, They generally are site or
building wide systems which are not tailored for specific process.
 Page 47 of 53

Base support and utility systems do not come into contact with drug product they are not considered
critical and therefore require routine commissioning and application of Good engineering practice
(GEP) rather than validation. The control of the critical parameters which these support systems
affect, however, should be validated.

Process, Process support and Utility systems

Nitrogen P C Enhanced 0.2 
Instrument air U NC GEP 5
Process air P C Enhanced 0.3 
Heating/Cooling PS NC GEP N/A
Steam/Hot Water U NC GEP N/A
Process Water P C Enhanced N/A
Non Process Water U NC GEP N/A
Process Vacuum PS NC GEP N/A
Mechanical seal fluids U NC GEP N/A
Solvent recovery PS C GEP N/A
Brine solution U NC GEP N/A
CIP P C Enhanced N/A
Solvent supply P C Enhanced N/A

System Type: Critical / Documentation / Filter requirements

(P,PS,U) Non Commissioning
Critical
Vents PS NC GEP N/A
Drain PS NC GEP N/A
Power U NC GEP N/A
Cooling Towers U NC GEP N/A
RT Water PS NC GEP N/A

Note: P – Process
PS – Process support
U – Utility
C – Critical
NC – Non critical
GEP – Good engineering practice

Design considerations:

a) Nitrogen

- The Nitrogen quality will have to meet the product specifications.

- The material of construction shall be SS 304, SS 316, Plastic or plastic lined steel and
copper (With point of use filter).
Page 48 of 53
- One micron filtration is typically needed, al though 0.2 microns units are used where
product purity necessitates. Fibrous materials, such as cotton, should not be used as
filtration media.

- Nitrogen distribution system design should not allow for sampling the nitrogen steam
for validation and operational reasons.

b) Instrument air

- It is unlikely that instrument air would be indirect contact with the product. These
systems are designed in accordance with Good engineering practices.

c) Process air

- In typical applications, process air comes into contact with the product, for instance
when plant air is used for product pressure transfer or to purge a product pipeline. The
air system shall meet the same requirement as Nitrogen. The consequence of exposing
the product to oxygen shall also be considered.

- The construction shall also be as same as Nitrogen.

d) Heating and Cooling systems:

- Heating and cooling systems, including cooling and chilled water, brine and heat
transfer fluid systems typically will not contact the product and, therefore will be
designed in accordance with Good engineering practice.

It is assumed that the equipment used for indirect heat transfer will not leak into
atmosphere or the product. Heat transfer media will so be selected considering potential
risk of leakage. Provision will be made to monitor system leakage.

e) Steam and
- Hot water systems

- Steam and hot water systems typically would not be used in applications where there is
exposure to the product. These systems are usually classified as Level 1 and will be
designed in accordance with Good engineering practice.

f) Process Vacuum systems:

- Vacuum systems will not be used to more than one process system.

- The system shall be designed so as to monitor vacuum level constantly.

- Protection shall be provided against back flow in case of power failure.

g) Non Process water, Plumbing, and Drain

- These systems typically are classified as Level 1 and should be designed in accordance
with Good engineering practice and applicable code requirements.

h) Mechanical seal Fluids

Page 49 of 53
- Food graded materials will be considered. If the seal fluid is likely to leak into the
product during a critical step, its impact on product quality should be assessed.

i) CIP/SIP

- The materials of construction should be consistent with the quality specification.

Typical acceptable materials are SS 304 and SS 316.

- The CIP distribution system design will allow the sampling of the CIP Stream for
validation and operational purposes.

j) Solvent Supply

- The material of construction shall be consistent with quality specification. Typical

acceptable materials are SS 304 and SS 316.

- The solvent distribution system design will allow the sampling of solvent stream for
validation and operational purposes.

k) Vents

- Vents will be dedicated to one process only with appropriate filters.

l) Power

- The facility will be equipped with 11 KV supply from APSEB. It is also provided with
the backup generator of suitable capacity for 100 % backup. These systems are
designed in accordance with Good engineering practice and applicable code
requirements.

- Emergency lighting systems will be provided wherever needed.

m) Cooling towers:

- Cooling towers of suitable capacities are planned for both air conditioning and
refrigeration systems. Sufficient care shall be taken to ensure optimum heat transfer and
energy efficient systems while designing the same

n) RT Water

- RT water systems including cooling towers typically will not come into contact with the
product and therefore will be designed in accordance with Good Engineering practice.

It is assumed that the equipment used for indirect heat transfer will not leak into the
product. Heat transfer media will so be selected considering potential risk of leakage.
Provision will be made to monitor system leakage.
Page 50 of 53

1.0 The room numbering is done on the following guide lines.

1st character denotes : Block code

2nd & 3rd Characters denote : Area code
4th Character denotes : Floor code (0 for ground floor, I for first floor and
2 for second floor.)
Last two characters denote : Room number

2.0 The total factory is divided into five blocks

The following are the details

1.0 --------------------------------- BLOCK

BLOCK CODE DEPARTMENT FLOOR CODE SEQUENTIAL NO.

CODE
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X

2.0 --------------------------------- BLOCK

BLOCK CODE DEPARTMENT FLOOR CODE SEQUENTIAL NO.

CODE
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X

3.0 --------------------------------- BLOCK

BLOCK CODE DEPARTMENT FLOOR CODE SEQUENTIAL NO.

CODE
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
Page 51 of 53

4.0 --------------------------------- BLOCK

BLOCK CODE DEPARTMENT FLOOR CODE SEQUENTIAL NO.

CODE
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X

5.0 --------------------------------- BLOCK

BLOCK CODE DEPARTMENT FLOOR CODE SEQUENTIAL NO.

CODE
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X
------------------- ------------------- X X X

1.0 The equipment numbering is done on the following guidelines:

1st to 6th character denotes : Room number

7th character denotes : E for Equipment

Last two characters denotes : Equipment number for specification room.

For example:

PAC-101-R-01 indicates

PAC – 101 indicates room number.01 of -----------------------------------------Area in first floor

i.e.; Reactor

Room

R indicates equipment reactor.

01 indicates Equipment number for that room i.e.; Reactor 1.

Page 52 of 53

The utility lines numbering is done on the following guidelines:

- The utility line number shall have 8 characters. (EX: PAC-001-CA)

“ 1st to 6th “ characters denotes room number

“ 7th to 8th ”characters denote ‘UTILITY CODE’

CA - COMPRESSED AIR

ST - STEAM

PT - POTABLE WATER

VC - VACUUM

CW - CHILLED WATER

HW - HOT WATER

PD - PROCESS DRAIN

DC - DUST COLLECTOR

VP - VACUUM POINT

PW - PURIFIED WATER

LT - LIGHTING

1P - SINGLE PHASE

3P - THREE PHASE

The AHU numbering is done on the following guide lines

1 The AHU number will have 12 characters

1st, 2nd & 3rd character denotes : System code

4th & 5th characters denotes : Type of filtration
6th & 7th characters denotes : Block code
8th & 9th characters denotes : AHU. No. in respective department
10th, 11th & 12th characters denotes : Cumulative AHU No. for the facility.
Page 53 of 53

2 The legend details area as follows

AHU denotes Air Handling Unit

TI denotes With terminal HEPA
T II denotes With Terminal 5 Micron Filter
T III denotes With Plenum 5 micron filter
PA denotes Paracetamol Block
ME denotes ----------------block
WH denotes Ware House
AD denotes Amenities
QC denotes Lab area
XX denotes AHU no. for the department
XXX denotes Cumulative AHU No.

An example for the above denotion is as follows

AHU T I PA 01 001

Where

AHU denotes Air handling unit

TI denotes With terminal HEPA Filter
PA denotes Paracetamol Block
01 denotes AHU no. of Paracetamol block
001 denotes Cumulative AHU No. for the API facility.
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