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HEALTH BIOTECH LIMITED

Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 1 of 55

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CC

PERFORMANCE QUALIFICATION
EQUIPMENT NAME: AIR HANDLING UNIT
EQUIPMENT NUMBER:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

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Sr. No. ITEM DESCRIPTION PAGE NO.


1.0 PROTOCOL APPROVAL 3
2.0 OVERVIEW 4
2.1 Objective 4
2.2 Purpose 4
2.3 Scope 4
2.4 Responsibility 4
2.5 Execution Team 5
3.0 PREREQUISITES 6
4.0 SYSTEM DESCRIPTION 6
5.0 REVALIDATION CRITERIA 7
6.0 TEST PROGRAMME 7
6.1 AIR FLOW VELOCITY TEST& NUMBER OF AIR CHANGES 8
6.2 INTEGRITY TESTING OF HEPA FILTERS 10
6.3 AIR PRESSURE DIFFERENTIAL TEST 11
6.4 AIR FLOW PATTERN TEST 12
6.5 TEMPERATURE AND RELATIVE HUMIDITY CONTROL TEST 13
6.6 NON-VIABLE AIR BORNE PARTICLE COUNT TEST 15
6.7 MICROBIAL MONITORING 17
6.8 SOUND LEVEL TEST 19
7.0 TEST INSTRUMENT DETAILS 20
8.0 DISCREPANCIES AND CORRECTIVE ACTION TAKEN 21
9.0 ANNEXURES 22
10.0 ABBREVIATIONS SHEET 22
11.0 SUMMARY AND CONCLUSION 23
12.0 FINAL REPORT APPROVAL 24
12.1 to ANNEXURE 1 TO 8 25-58
12.8
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1.0 PROTOCOL APPROVAL:

Signing of this approval page of Protocol indicates agreement with the qualification
approach described in this document. If modification to the qualification approach
becomes necessary, an addendum shall be prepared and approved .The protocol cannot
be used for execution unless approved by the following authorities.
This Performance Qualification Report of Air handling unit has been reviewed and
approved by the following persons:

FUNCTION NAME DEPARTMENT SIGNATURE DATE

PREPARED BY QUALITY
ASSURANCE

REVIEWED BY PROJECTS /
ENGINEERING

REVIEWED BY QUALITY
CONTROL

REVIEWED BY PRODUCTION

APPROVED BY QUALITY
ASSURANCE
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2.0 OVERVIEW:
2.1 OBJECTIVE:
The objective of this protocol is to demonstrate and provide documented evidence,
that the Air handling unit consistently provide and maintain an environmental condition
suitable for carrying out the respective operations. The performance qualification of Air
handling unit is a proof that the entire Air handling unit performs as intended under
actual production conditions. It is the beginning of the ongoing verification that the
system meets acceptance criteria for carrying out process validation.

2.2 PURPOSE:
The purpose of this protocol is to establish documentary evidence to ensure that the
installed Air handling unit will operate reproducibly and consistently within its full
dynamic range of operation according to manufacturer’s specifications.
2.3 SCOPE:
The Performance Qualification protocol describes the procedure, documentation,
references, acceptance criteria & revalidation criteria to be used for proving the
Qualification of Air handling unit installed.
2.4 RESPONSIBILITY:
The following shall be responsible;

Quality assurance officer/Executive – For Preparation of Protocol /Execution


Projects / Engineering Head – For execution

Production Head – For execution support

Quality Control Head-For analytical support

Quality Assurance Head – For adequacy and final approval


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2.5 EXECUTION TEAM:


The satisfactory operation of the Air handling unit shall be verified by executing the
qualification studies described in this protocol. The successfully executed protocol
documents that the Air handling unit is operational and is satisfactorily working.

Execution team is responsible for the execution of operation of air handling unit. All
executors involved with this protocol shall sign within the prescribed format given
below:

DEPARTMENT DESIGNATION
NAME SIGNATURE DATE

PROJECTS /
ENGINEERING

QUALITY CONTROL

PRODUCTION

QUALITY ASSURANCE
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3.0 PREREQUISITES:
 Installation and operational qualification shall be successfully completed before
starting performance qualification.
 Ensure that all equipment used in Validation activity are duly calibrated with
national / international traceability certificate. And copy of calibration certificates
shall be enclosed.
 All the personnel involved in the validation activities shall be trained on the
operational and documentation aspects of the HVAC validation.

4.0 SYSTEM DESCRIPTION:

The detail of the AHU is as follows,


This AHU 1 belongs to ISO 8.

Sr.No. DESCRIPTION SPECIFICATION

1) Equipment No

2) Services to
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5.0 REVALIDATION CRITERIA:


The Air handling unit has to be revalidated if
 There are any major changes in system components which affect the
performance of the system
 After major breakdown maintenance is carried out.
 As per revalidation date and schedule
 At the normal revalidation schedule i.e. Once in a year

6.0 TEST PROGRAMME


 Air Velocity and Air Changes
 Filter Integrity test
 Differential pressure test
 Airflow Pattern test
 Temperature and RH
 Non- Viable Particle count test
 Viable Particle counts
 Sound level test
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6.1 AIR VELOCITY TESTS AND NUMBER OF AIR CHANGES


6.1.1 Objective
To demonstrate that the air system is balanced and capable of delivering air velocities and
providing number of air changes as per requirement when calculated as per the respective
room volumes. Also calculate the number of air changes considering the air velocities
obtained from the terminal grill filters.

6.1.2 Equipment Used Fan type Anemometer.

6.1.3 Method Applied


Ensure that the blowers are switched “ON” prior to the start of the observations.
Ensure the Calibration status of the Anemometer.
Measure the air velocity 2 inches below the grill, at 5 locations (Four Corners and center)
with the Anemometer and record.
Calculate the average velocity of the air coming from Supply Grill.
Calculate the airflow by multiplying the average velocity with the effective filter area.
Air flow = Average Velocity x Face Area of the Air Inlet Grill / Filter
= Ft / Min. X Ft 2
= Ft 3 / Min. or CFM
Calculate the airflow for all the Supply Grill in the room and add values to get the total
airflow in the room (CFM).
Calculate the number of air changes per hour in the room by using the formula:
Air Changes / hour = Total air flow in the room (CFM) x 60
Room Volume (Ft 3 )

1 2
5

3 4
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6.1.4 Acceptance Criteria


Minimum and maximum velocity and subsequent airflow across the HEPA filter should be
within the design specification range to achieve the specified range of Air changes and
Differential pressure of the clean room.

The variation among the average velocity across the terminal grill supplying to the same
room should not be more than ±20%.

6.1.5 Result Recording


Raw data shall be collected in the data sheet. Measure and Record the air velocity at five
points of each Supply Grill. Recording shall be done in Annexure # 1 for respective rooms.
Calculate the average velocity and record it in the same Annexure # 1 average velocity
shall be used to calculate the air supply to each room and air change rate. Calculation is
given in the same Annexure # 1. Attach the calibration certificate of anemometer with the
report.

6.1.6 Evaluation of result:


The result complying with the specification range of individual velocity of the HEPA filter
shall achieve the desired airflow of the room and air change rate.
If velocity is not within the specified limit, damper should be regulated and if the minimum
velocity is not achievable, filter should be changed, irrespective to other test complying
with the acceptance criteria.
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6.2 INTEGRITY TEST OF HEPA FILTERS


6.2.1 Objective
To check the installed HEPA Filter integrity of terminal HEPA filters.

6.2.2 Equipment Used


Cold DOP smoke generator Aerosol photometer, duly calibrated with national /
international traceability certificate.

6.2.3 Method Applied


Position the smoke generator and introduce DOP smoke into the air stream, ahead of the
HEPA filters, at the concentration of 20 - 80g per liter of air at the filter’s designed airflow
rating and set the instrument at 100% concentration. Scan the downstream side of the
filter with an appropriate photometer probe at a sampling rate of at least 1 ft 3 / min. The
probe should scan the entire filter face and frame at a position about 1 to 2 inches from
the face of the filter. Scanning shall be done at the rate of maximum 2 feet per minute.

6.2.4 Acceptance Criteria


During scanning percentage of the DOP penetration shown by photometer should be less
than 0.03% through the filter media and should be ‘zero’ through mounting joints.

6.2.5 Result Recording


Record the results in the Annexure # 2. Record the details of the instruments used
including its calibration status filter identification number, location and upstream and
downstream concentration of DOP.
Attach the calibration certificate of the photometer with the report.
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Evaluation of result

Results, complying with the acceptance criteria, shall establish the integrity of the HEPA
filter suitable for clean area.
If any leakage is observed from the mounting, it has to be rectified through, adjustment
and application of food grade silicone sealant.
If leakage is observed from the Filter media more than the acceptable limit, filter shall be
replaced with new one and qualified.

Accepted limit for filter leakage

Any leakage greater than 0.03% of the upstream challenge aerosol concentration is
considered unacceptable and wants repairs and resetting.

6.3 AIR PRESSURE DIFFERENTIAL TEST


6.3.1 Objective
To demonstrate the capability of the air system to provide pressure gradient among the
different rooms.
6.3.2 Equipment Used
Magnehelic gauges
6.3.3 Method Applied
All HVAC systems shall be in continuous operation.
To avoid unexpected changes in air pressure and to establish a baseline, all doors in the
facility must be closed and no man movement to be allowed during the observations.
Observe the differential pressure through Magnehelic gauge.
Differential pressure of the room shall be recorded once in an hour for 72 hours.
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Acceptance Criteria
Pressure differentials across the two rooms of different class should be more than 1.5 mm
WG
Pressure differentials across the two rooms of same class should be more than 0.5 mm
WG
Pressure differentials should be maintained as indicated in the design conditions under
standard operating condition.

6.3.4 Result Recording


Measure and record differential Pressure in the Annexure # 3.

6.3.5 Evaluation of Results


Results, complying with the acceptance criteria and design requirement shall indicate the
correct balancing of Air Handling System. In case of failure, to meet the specifications,
adjustment in the return damper shall be done. Transient drop in differential shall be
recorded and investigation shall be done to find out the reason. Corrective action shall be
taken if required.

6.4 AIRFLOW PATTERN TEST


6.4.1 Objective
To demonstrate that the air system is balanced so that airflows through out the process
area to corridor and the airflow is uniform under terminal grill.
6.4.2 Procedure
Take a glass stick with cotton or sponge tied to it. Dip it in Titanium Tetrachloride solution
(TiCl4) and check for airflow direction in the rooms, under terminal grill, return filter or grill.
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6.4.3 Acceptance Criteria


 The air should flow towards the return air filter or grill.
6.4.4 Observations and Result Recording
Observe the air flow pattern as per the procedure mentioned above and record in the
Annexure # 4.
6.4.5 Evaluation of Result
Analyzing the airflow pattern, recorded in the test report, it can be concluded that the
airflow pattern, follows the acceptance criteria.
6.5 TEMPERATURES AND RELATIVE HUMIDITY CONTROL TEST

6.5.1 Objective
To demonstrate the ability of the HVAC system to provide temperature and Relative
Humidity within the specified range.

6.5.2 Equipment Used:


6.5.3 Method Applied
Air conditioning system shall be in continuous operation for at least 24 hours prior to
performing these tests. All lights in the critical area and controlled clean area to be ON
during the testing as well as during the 24 hours pre-conditioning period.
Place instruments near the return grill, keep it for a minute for stabilization and record the
observation.
6.5.4 Acceptance Criteria

The system shall be considered acceptable if the temperature and RH monitored during
72 hours at all locations falls within the specified temperature range.
The temperature of the area should be 25 ± 2OC and the Humidity should be 50±5%.
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6.5.5 Results
Measure and record temperature and RH at the locations, specified for every room in the
drawing attached as Attachment. Record the observations in the Annexure # 5 at an
interval of 120 minutes for a period of 72 hours in each location, which includes both static
and dynamic conditions.
At rest condition: Room with lights on and no machine in operation. Only operator will be
present in the area for recording.

6.5.6 Evaluation of Result


On the basis of the observations recorded in the test reports, it can be concluded that the
HVAC system is capable of consistently maintaining the required temperature and relative
humidity in the controlled areas.
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NON –VIABLE AIR BORNE PARTICLE COUNT TEST


6.6.1 Objective
To establish that in critical work locations within critical and non-critical area meets the
requirement for cleanliness class as per ISO 14644-1standard.
6.6.2 Equipment Used
Air borne particulate counter, duly calibrated with national / international trace ability.
6.6.3 Method Applied
Air conditioning system shall be in continuous operation for at least 24 hours prior to
performing these tests. Particulate count for all pre decided location in each location take
3 readings at the working height, shall be taken. Number of sampling location will be
decided as per the ISO 14644-1.
Number of sampling locations: A
Where A is area of cubicle in sq meters
FORMULA
Calculate the reading as per the formula mentioned below
a 1  a 2  .....  a i (a 1 - M) 2  (a 2 - M) 2  .....  (a i - M) 2
(M)  (SD) 
n (n - 1)
SD
(SEM) 
n
Upper Confidence limit (UCL)
UCL = M + (UCL Factor X SEM)

Where, n = number of observations.


UCL factor for 95% upper confidence limit for different number of locations is indicated in the
Following table.

UCL Factor for 95% upper confidence limit


No. of locations (L) 2 3 4 5-6 7-9 >9*
95% UCL Factor 6.3 2.9 2.4 2.1 1.9 NA
* When the number of locations is greater than 9, the calculation of a UCL is not required.
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6.6.4 Acceptance Criteria


The clean room or clean zone shall meet the acceptance criteria for an air borne
particulate cleanliness if
01.The average of the particulate count measured at each location falls at or below the
class limit
02. The mean of these averages falls at or below class limit with a 95% confidence limit
(as referred in standard ISO 14644-1).
The particle count of the area should not be more than 3520000 ( 0.5  size) and 29300
( 5.0 size) per cubic meter “at rest condition”.
The particle count of the area is Undefined “in operation condition”.

6.6.5 Result Recording


Data shall be collected in the data sheet. Measure and Record the particulate count at
various locations. Recording shall be done in Annexure # 6. Calculate the average count
for each location / zone and record it in the same data sheet.
Average count at each location / zone shall be used to calculate 95% upper confidence
limit (UCL) for each area. Calculation is given in the 6.6.3 with reference to standard ISO
14644-1. Produce the calculated data in the worksheet.
Attach the calibration certificate of Particle Counter with the report.
6.6.6 Evaluation of result:
The calculated UCL count should be as per the specified class range for individual areas.
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6.7 MICROBIAL MONITORING:


PASSIVE AIR SAMPLING

6.7.1 Objective:
To determine the viable air borne microbial contamination level in air for the Process
rooms.
6.7.2 Procedure
SCDA / SDA plates shall be exposed on the working plane in the area at the designated
locations as per layout /sampling plan attached . Plate exposure shall be done under
dynamic condition. Plate shall be exposed for 4 hours. Exposed plate shall be incubated
for 30 to 35°C for 48 Hrs followed by 20 to 25°C for further 72 Hrs. Plates shall be
observed for any microbial growth after 5 days.
In dynamic condition, normal man movement shall be there.

The Sampling shall be done in seven consecutive working days.

6.7.3 Acceptance Criteria

Sr.No Classification CFU/4 HOURS 90 mm Plate


01 ISO 5 <1
02 ISO 6 <3
03 ISO 7 <5
04 ISO 8 <50
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ACTIVE AIR SAMPLING

6.7.4 Procedure

Operate the Air sampler as per the SOP and collect air samples of 1000 L volume at the
designated locations as the sampling plan attached. Sampling shall be carried out in
dynamic condition. After sampling to remove the plate from the sampler aseptically. Label
the location number, block and date on plate. Exposed plates shall be incubated at 30 to
35°C for 48 Hrs followed by 20 to 25°C for further 72 Hrs.
In dynamic condition, normal man movement shall be there.

The Sampling shall be done in seven consecutive working days.

6.7.5 Acceptance Criteria

Sr.No Classification CFU/ 1000 L


01 ISO 5 <1
02 ISO 6 <7
03 ISO 7 <10
04 ISO 8 <100

6.7.6 Evaluation of Result


All microbial result complying with the acceptance criteria will establish the microbial
environment suitable for operation. Any microbial found in the sample shall be identified
and investigated for the source of contamination and decision on the HVAC System
qualification shall be taken.
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6.8 SOUND LEVEL TEST.

6.8.1 Purpose:
To Measure the air borne sound pressure levels produced by operating AHU.

6.8.2 Instruments used:


Digital Sound level meter

6.8.3 Conditions for testing:


All the noise/sound making system in the proximity of the area shall be switched off.

6.8.4 Testing procedure:


The instrument is to be set for the following values:
i) 65 db,
ii) Fast response mode.
ii) Keep of the probe of the sound level meter at 1 meter from the unit.
iii) Note down the values at the test spots.

6.8.5 Acceptance criteria:


i) The sound level should be less than 65 db at the working area.
ii) Data sheet for sound level monitoring shall be attached with the protocol as Annexure – 8.
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7.0 TEST INSTRUMENT DETAILS

Sr. No. Name of instrument Identification No. Make Calibration Checked


/Model valid up to by
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8.0 DISCREPANCIES AND CORRECTIVE ACTION TAKEN.

Discrepancies:

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Corrective action taken:

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Reviewed by:

Date:
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9.0 Annexure (s):

Sr.No. Annexure No. Title of Annexure

10.0 ABBREVIATIONS SHEET

SR. NO ABBREVIATION DESCRIPTION.

1. PQ Performance qualification.

2. AHU Air Handling unit

3. CFM Cubic feet per minute

4. NLT Not Less than

5. CFU Colony forming units.

6. NMT Not more than

7. RH Relative humidity.

8. FPM Feet per minute

9. IPC In process container

11.0 SUMMARY AND CONCLUSION


Summary:

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Conclusion:

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12.0 FINAL REPORT APPROVAL


It has been verified that all tests required by this protocol are completed, reconciled and attached
to this protocol or included in the qualification summary report. Verified that all amendments and
discrepancies are documented, approved and attached to this protocol.
Signature in the block below indicate that all items in this performance qualification report of air
handling unit have been reviewed and found to be acceptable and that all variations or
discrepancies have been satisfactorily resolved and the system is qualified for its routine use.

NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PROJECTS/
ENGINEERING

PRODUCTION

QUALITY
ASSURANCE
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12.1 ANNEXURE - 1

AIR VELOCITY MEASUREMENT AND CALCULATION OF AIR CHANGES

AHU No.: __________ Specified Air Changes per Hour: _______________

Test Condition: Room At Rest Name of the Instrument : Anemometer

Calibration certificate No:


Avg Supply Air Flow
Sample Locations Total Room Air Changes
Filter Velo Terminal F=
CFM Volume per Hour
No. (V) Area VxA
L1 L2 L3 L4 L5 (T) Ft3 (R) N =T x 60/R
fpm Ft2 (A) CFM
Room No Room Name: Air Lock

Room No Room Name: Clean IPC store

Room No Room Name: Dispensing material hold area

Room No Room Name: Equipment clean store


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Comments:

Reviewed By: Date:

Approved By: Date:


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12.2 ANNEXURE - 2

INTEGRITY TESTING OF HEPA FILTERS

AHU. No: __________ Location Name:

Name of the Instrument: Aerosol Photometer

Calibration certificate no:

Upstream Downstream
Checked
Sr.No. Room Name Filter No. Concentration Concentration
By
% %
1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.
Comments:
Reviewed By: Date:

Approved By: Date:

12.3 ANNEXURE - 3 DIFFERENTIAL PRESSURE TEST


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AHU no: ______________ Date of Test: From:_______To_______


Name of the Instrument: D.P. gauge Operating range: __________
Acceptance criteria:______________ Room No:_________________
Room Name:___________________ With respect to:_______________________

PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL

Comments

Reviewed By: Date:

Approved By: Date:


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12.3 ANNEXURE - 3 DIFFERENTIAL PRESSURE TEST


AHU no: ______________ Date of Test: From:_______To_______
Name of the Instrument: D.P. gauge Operating range: __________
Acceptance criteria:______________ Room No:_________________
Room Name:___________________ With respect to:_______________________
PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL

Comments:

Reviewed By: Date:

Approved By: Date:


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12.3 ANNEXURE - 3 DIFFERENTIAL PRESSURE TEST


AHU no: ______________ Date of Test: From:_______To_______
Name of the Instrument: D.P. gauge Operating range: __________
Acceptance criteria:______________ Room No:_________________
Room Name:___________________ With respect to:_______________________
PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL

Comments:

Reviewed By: Date:

Approved By: Date:


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DATE:

12.3 ANNEXURE - 3 DIFFERENTIAL PRESSURE TEST


AHU no: ______________ Date of Test: From:_______To_______
Name of the Instrument: D.P. gauge Operating range: __________
Acceptance criteria:______________ Room No:_________________
Room Name:___________________ With respect to:_______________________
PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 34 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 35 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Comments:

Reviewed By: Date:

Approved By: Date:

12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST

AIR FLOW Passed Checked by


From To /Fail
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 36 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Comments:

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 37 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST

AIR FLOW Passed Checked by


From To /Fail

Comments:

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 38 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST

AIR FLOW Passed Checked by


From To /Fail

Comments:

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 39 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.4 ANNEXURE - 4

AIR FLOW PATTERN TEST

AIR FLOW Passed Checked by


From To /Fail

Comments:

Reviewed By: Date:

Approved By: Date:

12.5 ANNEXURE - 5

TEMPERATURE AND RELATIVE HUMIDITY CHECKS


AHU No ______________ Calibration certificate no: ______________
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 40 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Date of Testing: _______________ Specified Class: ISO 8

Name of the Instrument:________________

Limit of temperature: 25 2°C Limit of RH: 50±5%.

Table No: 1 Environmental control recording chart

Checked
Time
Air Lock Clean IPC store By
(Hrs)
Sign/Date
Temp RH Temp RH
(°C) (%) (°C) (%)
Date Day

Time Air Lock Clean IPC store Checked By


(Hrs) Sign/Date
Temp (°C) RH (%) Temp (°C) RH (%)
Date Day
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 41 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Date Day

Time Dispensing mat. hold area Equipment clean store Checked By


(Hrs) Sign/Date
Temp (°C) RH (%) Temp (°C) RH (%)
Date Day
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 42 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Date Day

Dispensing mat. hold


Time Equipment clean store Checked By
area
(Hrs) Sign/Date
Temp (°C) RH (%) Temp (°C) RH (%)
Date Day
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 43 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Comments:

Reviewed By: Date:

Approved By: Date:

12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 44 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

Test Conditions: Static Acceptance limit:

Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 45 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Static Acceptance limit:

Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL
Comments

Reviewed By: Date:

Approved By: Date:

12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 46 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

NON -VIABLE PARTICLE COUNT TEST


ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Static Acceptance limit:


Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5
6
7

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:

12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 47 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

NON -VIABLE PARTICLE COUNT TEST


ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Static Acceptance limit:


Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:

12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 48 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

NON -VIABLE PARTICLE COUNT TEST


ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Dynamic Acceptance limit:


Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 49 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Dynamic Acceptance limit:


Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:


HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 50 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:

Date of Testing: _______________ Specified Class : ISO - 8

Name of the Instrument: Laser Based Air Borne Particulate Counter.

Period of Sampling: 1 Minute Calibration certificate no:

Test Conditions: Dynamic Acceptance limit:


Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5

Mean (M) of all locations


Standard Deviation (SD)
Standard error (SEM)
UCL

Comments

Reviewed By: Date:

Approved By: Date:

12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 51 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

PASSIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

ACTIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 52 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

PASSIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

ACTIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 53 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

PASSIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

ACTIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 54 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.7 ANNEXURE - 7

PASSIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:

ACTIVE AIR SAMPLING

Refer Report No: Room Name:

Date: From________To____________

Comments

Reviewed By:

Approved By:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi

HVAC VALIDATION PROTOCOL CUM REPORT Page No. 55 of 55

PROTOCOL NO.:
EFFECTIVE REVIEW DATE:
DATE:

12.8 ANNEXURE - 8
SOUND LEVEL TEST

Limit: 1) For Sound level: NMT 65 db

Sr. No. Location Reading

Sound level
(db)

2.

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