Article Wjpps 1386003302

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
P.Ramasubramaniyan et al. World Journal of Pharmacy and Pharmaceutical Sciences

Volume 2, Issue 6, 4698-4718. Review Article ISSN 2278 4357
EQUIPMENT QUALIFICATION ON BLISTER PACKING MACHINE
Ramasubramaniyan.P*, Palanichamy.S, Srinag.T,Sharanya.N ,Lakshmi.M, Solairaj.P
Department of Pharmaceutics, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi,

Tamil Nadu, India.
Article Received on ABSTRACT

16 August 2013, This article discusses about the equipment qualification on blister
Revised on 15 Sept 2013, packing machine which covers different types of qualification like
Accepted on 12 November
2013
design, installation, operational and performance qualification and re-
qualification. It also includes the process involved in the blister
*Correspondence for
packing machine and detail description of equipment parts like
Author: unwinding station, forming station, sealing station, heating station,
cooling station, feeder, lidding material and labeling through
* Dr. P. Ramasubramaniyan,
packaging. It also covers the details of packaging importance and its
Professor, Department of
Pharmaceutics, Sankaralingam types.
Bhuvaneswari College of Keywords: Equipment, Qualification, Blister Packing Machine,
Pharmacy, Sivakasi, Tamil Packaging.
Nadu, INDIA.
ramskit@yahoo.com
INTRODUCTION
Equipment
The collective analytical measurement instruments, in conjunction with firmware, assembled
to perform a mechanical process. In a computerized system, the equipment is controlled by
the computer system. The computer collects measurement data from the equipment. A device
or collection of components that perform a process to produce the result. ([1])
Qualification
1. Action of proving that any premises, systems and items of equipment work correctly and
actually lead to the expected results. The meaning of the word validation is sometimes
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extended to incorporate the concept of qualification.

2. The action of providing that any equipment or process works correctly & consistently
and produces the expected results. Qualification is part of, but not limited to, a validation
process.
Types of Qualification
1. Design Qualification (D.Q)
2. Installation Qualification (I.Q)
3. Operational Qualification (O.Q)
4. Performance Qualification (P.Q)
5. Re-Qualification. ([2])
History of Validation
The concept of validation was first proposed by two Food and Drug Administration (FDA)
officials, Ted Byers and Bud Loftus, in the mid 1970s in order to improve the quality of
pharmaceuticals. ([3]) It was proposed in direct response to several problems in the sterility of
large volume parenteral market. The first validation activities were focused on the processes
involved in making these products, but quickly spread to associated processes including
environmental control, media fill, equipment sanitization and purified water production. The
concept of validation was first developed for equipment and processes and derived from the
engineering practices used in delivery of large pieces of equipment that would be
manufactured, tested, delivered and accepted according to a contract. ([4] The use of validation
spread to other areas of industry after several large-scale problems highlighted the potential
risks in the design of products. ([5])
Reason for Validation

Validation is "Establishing documented evidence that provides a high degree of assurance
that a specific process will consistently produce a product meeting its pre-determined
specifications and quality attributes. A properly designed system will provide a high degree
of assurance that every step, process, and change has been properly evaluated before its
implementation. Testing a sample of a final product is not considered sufficient evidence that
every product within a batch meets the required specification FDA (1987). ([6])
Design Qualification (DQ)

It is the documented verification that the proposed design of the facilities, systems and
equipment is suitable for the intended purpose.
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Installation Qualification (IQ)

It is the documented verification that the equipment or systems, as installed or modified,
comply with the approved design, the manufacturers recommendations and/or user
requirements.
Operational Qualification (OQ)

It is the documented verification that the equipment or systems, as installed or modified,
perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ)

It is the documented verification that the equipment and ancillary systems, as connected
together, can perform effectively and reproducibly based on the approved process method
and specifications.
User Requirements Specification

The User Requirements Specification should be treated as a contractual document avoiding
conflicts with other technical specification documents. The URS should not be considered a
mere part of the validation documentation but rather the main and possibly only specification
document for the equipment.
The URS should as a minimum, cover all mandatory parts including those necessary to
guarantee the final product quality and achieve compliance with the rules.
Ideally, the requirements should be independent from the suppliers product and express the
customer needs without addressing specific design solutions. ([7])
URS Scope
User Requirement Specifications (URS) Scope includes but is not limited to;
Level-1, full details of end user operability.
Level-2, full details of functionality.
Level-3, software functionality interface.
A full description of the required system performance.
Performance criteria, critical parameters and operating range.
Cleaning and maintenance requirements.
Appropriate regulatory requirements.
Documentation requirements.
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Training requirements.
All none industry standard testing that may be required. ([8])

Design qualification is the documentation of the planning phase, including the decision
making for the equipment. Design qualification takes place before the equipment is
constructed. With the design qualification, the conformity of the equipment or facility
planning with certain requirements is reviewed. To this end, the requirements laid out in the
user requirements are compared with the specifications compiled by the supplier (technical
specifications) and confirmed in writing. ([9])

The (IQ) execution; verifies that the equipment, and its ancillary systems or sub-systems have
been installed in accordance with installation drawings and or specifications. It further details
a list of all the GMP requirements that are applicable to this particular installation
qualification.
These requirements must all be satisfied before the IQ can be completed and the qualification
process is allowed to progress to the execution of the Operational Qualification.
Installation Qualification Scope (IQ)

The scope of the IQ testing/inspections will cover the under listed subjects, but is not
restricted to them alone.
Verify all components parts.
Verify installation is as specified.
Insert a brief description of the validated product process.
Insert a brief description of the operational function.
Verify supplied voltages.
Verify whether the electrical installation qualification (IQ) complies.
Verify all alarms and visual displays.
Confirm the issue level of software.
Identify and verify the serial & model numbers.
Review all calibration certificates.
Verify signal continuity.
Verify the ambient conditions.
Verify the documentation provided for the maintenance of the system. ([10])
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Before installation
Obtain manufacturer's recommendations for installation site requirements.
Check the site for the fulfillment of the manufacturer's recommendations (utilities such as
electricity, water and gases plus environmental conditions such as humidity, temperature,
vibration level and dust). Allow sufficient shelf space for the equipment itself, related
SOP's, operating manuals, logbooks and software. ([11])
The most important aspects to consider during IQ

Provide as-built documentation.
Check training reports.
Check that documentation is complete.
Check calibration reports.
Identify piping and instrumentation. ([12])
Operational Qualification (OQ)

Operational qualification is defined as Documented verification that the system or sub-
system performs as intended throughout all anticipated operating ranges. ([13])
OQ demonstrates that an instrument will function according to its operational specification in

the selected environment.
Operational Qualification (OQ) is the process of demonstrating that a instrument will

function according to its operational specification in the selected environment. Before OQ
testing is done, one should always consider what the instrument will be used for. Testing may
be quite extensive if the instrument is to be used for all types of applications and where some
of these place great demands on the performance of the system. ([14])
OQ should include, but not be limited to the following

(a) Tests that have been developed from knowledge of processes, systems and equipment;
(b) Tests to include a condition or a set of conditions encompassing upper and lower
operating limits, sometimes referred to as worst case conditions.
The completion of a successful Operational qualification should allow the finalization of
calibration, operating and cleaning procedures, operator training and preventative
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maintenance requirements. It should permit a formal "release" of the facilities, systems and
equipment. ([15])
Typical tests in the OQ include the following:
Alarm tests
Behavior of the system after energy breakdown
Accuracy of filling lines
Transportation speed in a sterilization tunnel
Temperature distribution in an autoclave
Performance of a washing machine, accuracy of a weighing system([16])
Performance Qualification
PQ demonstrates that a balance or instrument consistently performs according to a
specification appropriate to its routine use.
Performance Qualification (PQ) is the process of demonstrating that an instrument
consistently performs according to a specification appropriate to its routine use. The test
frequency is much higher than for OQ. Another difference is that PQ should always be
performed under conditions that are similar to routine sample analysis PQ should be
performed on a daily (or at least a weekly) basis, or whenever the instrument is used.
The test frequency depends not only on the stability of the equipment but also on everything
in the system that may contribute to the analysis results.
1. Define the performance criteria and test procedures.

2. Select critical parameters.
3. Define the test intervals
PQ should include, but not be limited to the following:
(a) Tests, using production materials, qualified substitutes or simulated product, that have
been developed from knowledge of the process and the facilities, systems or equipment;
(b) Tests to include a condition or set of conditions encompassing upper and lower operating
limits. ([17])
The following technical systems need to be performance-tested and qualified:

High purity water systems (monitoring of the quality parameters: pH, Total Organic
Carbon, conductivity, Central processor unit, temperature)
Heating, ventilation and air conditioning systems (temperature, pressure, humidity)
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Complex connected systems (e.g., filling line, BPI production line; performance
parameters) ([18])
Requalification
Requalification is the repetition of the qualification effort or a selected portion of it. ([19])
Packing
Packaging is defined as the collection of different components which surround the
pharmaceutical product from the time of production until its use.
Background
Two basic types of pharmaceutical blister packages exist. In one variety the cavity is
constructed of clear, thermoformed plastic, and the lid is formed of clear plastic or a
combination of plastic, paper, and/or foil. The other type of package contains foil as an
essential component of both webs and its cavity is created by cold stretching. ([20])
Types of Packaging
1. Thermoforming
2. Cold forming
Importance of Packaging
Protects against all adverse external influences that can alter the properties of the
product.
Protects against biological contamination.
Protects against physical damage.
Carries the correct information and identification of the product.
Tamper evident / Child resistance/ Anti counterfeiting.
Functions of Packaging
1. Containment
-Not to leak, nor allow diffusion and permeation
-Strong enough to hold the contents during handling
2. Protection
-Light
-Moisture
-Oxygen
-Biological contamination
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-Mechanical damage
-Counterfeiting
General properties of blister packaging material:

- Tensile strength
- Tear strength
- Impact resistance
- Stiffness
- Temperature resistance
- Moisture resistance
Factors Affecting Blister Thickness

A. Material: The nature of material e.g. softening temperature, hardening time, elasticity etc.
B. Process: Pressure and plug system usually produce forming produces thicker top section
while in vacuum forming, it is thicker near the base and thinner at the top.
C. Essential machine operation:
1. Heating and thermoforming.
2. Cold forming.
3. Feeding and filling.
4. Heat sealing of the bidding material.
5. Punching out or guillotining the tray from the web.
6. Printing of the lidding web.
7. Batch marking.
Advantages of Blister Packaging

1. Blisters are very inexpensive to produce.
2. Can be used for promoting products.
3. Protects and holds the product securely.
4. Many sizes available, from small unit-dose.
5. Allows products to be seen, but not touched.
6. Product is very visible.
Disadvantages of Blister Packaging

1. Blisters require some type of a card to seal the blister.
2. Requires heat sealing the blister to the card.
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Blister Packaging Components

The four basic components of pharmaceutical blister packages are the forming film, the
lidding material, the heat-seal coating, and the printing ink. Forming films account for
approximately 8085% of the blister package, and lidding materials make up 1520% of the
total weight of the package. Since the forming film and the lidding material form an
integrated package, they must match precisely.
Forming film
The forming film is the packaging component that receives the product in deep drawn
pockets. One key to package success is selecting the right plastic film for the blisters in terms
of its property type, grade, and thickness. Consideration must be given to the height and
weight of the product, sharp or pointed edges of the final package, and the impact resistance,
aging, migration, and cost of the film. The plastic also must be compatible with the product.
Factors influencing package production and speed of assembly must be taken into account,
including heat sealing properties and the ease of cutting and trimming formed blisters.
Lidding materials
The lidding material provides the base or main structural component upon which the final
blister package is built. It must be selected according to the size, shape, and weight of the
product as well as the style of the package to be produced. Lidding materials range in caliper
or thickness from 0.36 to 0.76 mm, but 0.460.61 mm is the most popular range. The surface
of the lidding material must be compatible with heat-seal coating process. Clay coatings are
added to the lidding material to enhance printing. Heat-sealing and printability are both
important considerations in blister packaging, and the lidding material must offer the best
workable compromise.
Printing inks
Printing inks provide graphics and aesthetic appeal. They can be applied to the lidding
material by letterpress, gravure, offset, flexographic, or silk-screen printing processes.
Printing inks must resist heat sealing temperatures as high as 300 C without showing any
discoloration or tackiness (blocking). In addition, they must sufficiently resist abrasion,
bending, and fading and must be safe for use with the intended product. Printing inks should
not contain excessive amounts of hydrocarbon lubricants, greases, oils, or release agents.
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Qualification tests should always precede production runs. Finally, printing inks must comply
with FDA recommendations.
Cold-formed foil/foil
Best known to Americans is the blister package made of a foil, film, paper, or multimaterial
backing that is adhered to a sheet of thermoformed plastic blisters. However, a less common
type of blister is the foil/foil lamination used for products that are particularly susceptible to
moisture and/or light. Unlike all-plastic blisters, these are not thermoformed but instead are
cold-pressed into shape. Products that require the highest degree of protection are packed in
an all-foil package. Cold-formable foil is finding favor because it is the only material that
provides a 100% barrier to moisture, oxygen, and light.
Machinery and assembly

Blister packaging machinery
Modern thermoformfillseal machines can operate at speeds <800 packages/min. Today,
much of the emphasis in improving production is placed on applying microprocessor controls
that electronically connect the filling and forming equipment with other downstream
machinery for cartooning and wrapping. These controls also feed tablets or liquids into the
unit-dose blisters, ensuring that an exact volume is put into each. Modern machinery also
uses integrated vision systems to help ensure the accuracy of the fill and the integrity of the
product in the blister. These machines have become quite versatile and can readily
accommodate several types of lid stocks and base stocks, allowing the manufacturer to obtain
better compatibility between the medicine and its packaging material as well as better patient
compliance.
Detailed assembly
Blister packaging machines typically operate with intermittent motion. The seal is made
during the dwell time required for thermoforming. The essential parts and functions of an
intermittently operating packaging machine include the following:
The unwinding station

The unwinding station supplies the forming films and the lidding material at a rate
corresponding to the speed of the packaging machine.
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The heating station

The heating station raises the temperature of the plastic forming films to a level suitable for
deep drawing. Forming films containing the polyvinyl chloride (PVC) support material are
heated to 120140C. Polypropylene (PP) forming films are heated to 140150C. Forming
films containing aluminum are not heated before the forming process.
The forming station

The forming station forms the plastic blister cavities via compressed air or die plates. Films
containing aluminum are formed with mechanical forming tools only.
The cooling station

The cooling station cools PP films after the forming process. Laminates containing PVC or
aluminum do not need to be cooled.
The feeding machine

The loading area fills the blister cavities with product. The feeding machine can be linked, or
the product to be packaged can simply be swept into the blisters.
The sealing station

The sealing station heat seals the lidding material to the forming film that contains the
product. All heat-sealing methods mate the blister and lid under constant pressure for a
specified time, during which heat is supplied. The mating surfaces fuse and bond, setting
almost instantaneously when heat input stops. Depending on the type of machine, the sealing
temperature typically ranges between 140 and 340C.
The cooling station

The cooling station is necessary with all forming films. PP forming films must be cooled
longer than other types of film.
Labeling through packaging

Packages are labeled, notched, and then marked with a batch number at the coding station.
The perforating device makes a cross-shaped perforation along the sealing seams. At the
punching station, the packages are then separated into sheets that typically contain from 10 to
20 individual blisters. The vision system checks the filled packages for defects. Finally, a
multipacking machine packs the individual packages into bigger cartons. ([21])
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METHODOLOGY
The execution of equipment qualifications involved the following:

Development of IQ, OQ and PQ protocols.
Approval of IQ, OQ and PQ protocols.
Executing the IQ, OQ and PQ.
Workout of IQ, OQ and PQ report.
Approval of IQ, OQ and PQ report.

The Blister packing machine was to be checked whether the user requirements are fulfilled.

Instrument specifications during installation:
Table No. 1: Equipment details
1 Equipment to be installed as per drawing(s)/ manufacturers

recommendation.
2. Equipment identification nameplate is to be visible.
3. Major components are to be securely assembled.

4. Any physical damage is to be checked.
5. Required electric connections are to be tight and grounded. Earthing
connection is to be done properly.
6. Sufficient space is to be provided around the equipment/ system for
servicing.
7. All moving parts are to be covered with suitable guard.
8. All utilities related to equipment are to be connected.
9. Parts are to be accessible for easy cleaning.
While installing the machine, the following parameters were observed and confirmed
Identification of Execution Team members.

Purchase order verification.
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Verification of Manual, Drawing and Related documents.

Installation Verification.
Verification of Material of construction.
Verification of Utilities.
Major component verification.
Operational Qualification
The machine was run as per the operating instructions for 30minutes with empty load and
observed the operation and recorded.
While machine was in operation, switch off the mains power supply.
After few minutes, the machine was restarted and the operation performance was
observed and the result was recorded.
During the operation of equipment, the temperature was controlled or adjusted to 1100 c
to 1600c to form the blister cavities and then adjusted to 1400 c to 3400 c for sealing the
lidding material. Then the operation was observed. The result of operational qualification
was noted.
While operating the machine, the following tests are to be carried out:
Safety features;
Alarm tests;
Behavior of the system after energy breakdown;
Accuracy of filling lines;
Continuity of Operation;
Power Failure Recovery Study;
Functionality of Push buttons/switches provided on Electrical /Control panel;
Temperature Controller performance verification;
Operational Performance of ACG Pampac Blister Packing Machine and
Performance Verification of ACG Inspection system
During PQ, the temperature was adjusted from 1100C to 1600C for optimal forming
temperature study and finally the temperature was fixed.
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Later the temperature was adjusted to 1800C - 2400C to study the optimal sealing
temperature study and finally the temperature was fixed.
During performance of the machine, the following parameters were observed:
Defective tablets;
Missed tablets;
Black spots;
Machine speed;
Optimal forming temperature;
Optimal sealing temperature.
RESULTS AND DISCUSSION

The equipment qualification of Blister packing machine was conducted by four types
namely, Design qualification, Installation qualification, Operation qualification and
Performance qualification.
Design Qualification
For qualifying the Blister packing machine, the vendor manufactured and supplied the
machine as per the requirements of the user. The design qualification was satisfied.
Installation Qualification
i. Instrument specifications:
1. Equipment was installed as per drawing(s)/ manufacturers recommendation.
2. Equipment identification nameplate was visible.
3. Major components are securely assembled.
4. There was no physical damage.
5. Required electric connections and earthing connections are tightly grounded and done
properly.
6. Sufficient space was provided around the equipment/ system for servicing.
7. All moving parts were covered with suitable guard.
8. All utilities related to equipment are connected.
9. Parts were accessible for easy cleaning.
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The following parameters are within the limits and it was observed that the installation of
the equipment was in proper manner.
Identified the Execution Team members.
Verified the Purchase order.
Verified the Manual, Drawing and Related documents.
Installation was verified.
Material of construction was verified.
Utilities were verified.
Verified the Lubricants.
Procedures were identified.
Installation checks specific to equipment were identified and carried out as per individual
test procedures.
Verified the Major component.
The details of each component were recorded and the supplied component was checked
and installed as per the User Requirement Specification / Manufacturers
recommendations. All are found correct. (Table No. 10).
Table No. 2: Basic Unit
Description Specified Supplied

Make ACG Pampac ACG Pampac
Model B45 R B45 R
Sr. No. BR631401666-10 BR631401666-10
Inspection System Shall be provided Provided
Temperature control and Shall be provided on
provided on MMI
Indication MMI
Shall be provided for provided for various
various access operations access operations of
Servo drivers
of Pulling & perforation Pulling & perforation
stations with other stations with other
4400(L) x 2170(W) x
4400(L) x 2170(W) x
Machine Dimension 2350
2350 (H) mm.
(H) mm.
Maximum 240 mm Maximum 240 mm
Forming Area (Width) x 210mm (Width) x 210 mm
(Advance) (Advance)
Forming Depth Upto 12mm Up to 12mm
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Up to 45 cycles per
Upto 45 cycles per minute
minute for PVC
for PVC
Forming cycles Up to 35 cycles per
Upto 35 cycles per minute
minute
For ALUMINIUM
For ALUMINIUM
Upto 9.5 meters per Up to 9.5 meters per
Forming Speed
minute minute
Operational Qualification
Operational qualification was carried out by the vendor under the supervision of machine
operator, validation person and the engineering person. The following parameters are
within the limits:
Alarm tests were good.
System after energy breakdown works properly.
Accuracy of filling lines was good.
Continuity of Operation was good.
Power Failure Recovery Study was good.
Functionality of Push buttons/switches provided on Electrical /Control panel works
properly.
Temperature Controller performance verification was within the limit.
The safety feature testing was carried out by operating the equipment. The exercise
was repeated for 2 more times. All the safety features were tested and found in
compliance with the URS.
Table No. 3: Safety Features
Description of
Sr.
safety Method of Testing Acceptance Criteria
No.
features
Foil Consumed / take out the
Base Foil end Machine Stops at Zero
1. base foil manually during
sensor Position
machine is in operation
Lidding Foil Consumed / take

Lidding Foil Machine Stops at Zero
2. out the Lidding foil manually
end Position
during machine is in operation
Buzzer will made ON
Sensor for
If the foil roll level reaches to indicate the operator
3. base foil Low
low after completion of set
level
time machine will stop
4. Loop sensor Manually Operate the sensor Base foil unwinding
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for base foil motor shall be ON

unwinding
Sensor for When sensor detects the joint The joint blister will
5.
Base foil Joint in the base foil get rejected at 450
Sensor for
When sensor detects the joint The joint blister will
6. Lidding foil
in the Lidding foil get rejected at 450
Joint
Critical Parameters
Some important critical parameters such as Continuity of Operation, Power Failure
Recovery Study, Functionality of Push buttons/switches provided on Electrical/Control
panel, Temperature Controller performance verification, Operational Performance of ACG
Pampac Blister Packing Machine Model: B45 R and Performance Verification of ACG
Inspection System were performed and the results are presented.
Continuity of Operation
Machine ran for 30 minutes and found no abnormal noise or vibrations. Motor ran
continuously without tripping, motor/machine parts were not excessively heated up.
Hence continuity of operation with empty load for 30 minutes was found within the limits.
Power Failure Recovery Study

Power failure alarm was in good condition.
When power supply was stopped, machine also got stopped at zero position.
When power resumes, machine started with the existing set parameters.
The following parameters are within the limits
Machine speed was verified.
Optimal forming temperature was good.
Optimal sealing temperature was good.
Black spots were identified and rejected.
Missed tablets were identified and rejected.
Defective tablets were identified and rejected.
Machine Speed Verification:

The machine speed was maintained at three different ranges such as minimum (10 cycles /
min), optimum (25 cycles / min) and maximum (43 cycles / min) in order to evaluate the
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forming and sealing of the blister as specified in protocols. The forming and sealing of the
blister was found satisfactory.
Optimal Forming Temperature Study

This study was carried out using the dummy product with PVC as forming foil at different
machine speeds (10, 15, 20, 25, 30, 35, 40, 43 cycles / min) under various temperatures
such as 110C, 120C, 130C and 140C. The parameters like pocket shape, deformations,
pin holes, cracks and dents were evaluated at top and bottom of the heating plate. The
results showed that all the parameters were found within the limits.
Optimal Sealing Temperature

This study was carried out using the dummy product foiled with PVC as forming foil and
aluminium as lidding foil at different machine speeds (10, 15, 20, 25, 30, 35, 40, 43 cycles
/ min) under various temperatures such as 180C, 195C, 220C, 235C and 250C. The
parameters like knurling quality, pin holes, cracks, dents and leak test were evaluated. The
results proved that all the parameters were found within the limits.
Performance of ACG inspection system

This study was performed at 10, 20 and 30 cycles / min to evaluate or identify the defects
such as missed tablets, black spots and defective tablets. From the results it was found that
the evaluated parameters were within the limits.
After completion of performance qualification we observed that the obtained results were
within the limits and found satisfactory.
SUMMARY
The design, installation, operational and performance qualification of ACG-PAMPAC
BLISTER PACKING MACHINE, Model: B45 R was performed as per the approved
qualification protocol.
During installation qualification, the material of construction of all product contact parts
were verified and certified as SS316L and its equivalent and the non contact parts were
certified for SS304 and its equivalent.
All the utilities are connected and found to be adequate. All the major components i.e.
Basic Unit, Base foil unwinding station, Heating station, Forming station, Linear indexing
station, Feeding station, Lidding foil unwinding station, Sealing station, Cooling station,
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Punching & Perforation station, Rotary pickup station, Web support assembly, Electrical
controls and other were identified, installed, checked and mounted properly during
installation qualification.
During operation qualification, all the accessories provided to the equipments were
calibrated and the results were found satisfactory.
Control panel components and function of each key/component of the panel against its
specified function was checked as per the operational instructions and the results were
found satisfactory.
Safety feature testing has been tested as per the procedure mentioned in the protocol and
all the results are within the limits.
The critical operating parameters such as
Verification of continuity of operation,
Power failure recovery study,
Verification temperature controllers,
Operation performance of Blister packing machine and
Verification of security, Recipe management functionalities were verified and found
correct.
All the observations during operational qualification were found satisfactory and were
within the limits.
As part of performance qualification, the machine was run with dummy tablets at 10
cycles/min, 20 cycles / min and 30 cycles / min and the quality of blisters were found
satisfactory.
CONCLUSION
All the results observed for individual qualification steps are found within the limits as per
the proposed protocols and the equipment was successfully qualified in compliance with
the URS, cGMP and FDA requirements.
The installation, operational and performance qualification of ACG-PAMPAC BLISTER
PACKING MACHINE, Model: B45 R was performed as per the approved protocol
No.GITPRIOP307 and GITPRPQP307 respectively. Hence the ACG-PAMPAC BLISTER
PACKING MACHINE, Model: B45 R can be released for routine use.
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WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

P.Ramasubramaniyan et al. World Journal of Pharmacy and Pharmaceutical Sciences

EQUIPMENT QUALIFICATION ON BLISTER PACKING MACHINE

Ramasubramaniyan.P*, Palanichamy.S, Srinag.T,Sharanya.N ,Lakshmi.M, Solairaj.P

Department of Pharmaceutics, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi,

Article Received on ABSTRACT

extended to incorporate the concept of qualification.

Reason for Validation

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

User Requirements Specification

Design Qualification (DQ)

Installation Qualification (IQ)

Installation Qualification Scope (IQ)

The most important aspects to consider during IQ

Operational Qualification (OQ)

OQ demonstrates that an instrument will function according to its operational specification in

Operational Qualification (OQ) is the process of demonstrating that a instrument will

OQ should include, but not be limited to the following

1. Define the performance criteria and test procedures.

The following technical systems need to be performance-tested and qualified:

General properties of blister packaging material:

Factors Affecting Blister Thickness

Advantages of Blister Packaging

Disadvantages of Blister Packaging

Blister Packaging Components

Machinery and assembly

The unwinding station

The heating station

The forming station

The cooling station

The feeding machine

The sealing station

The cooling station

Labeling through packaging

The execution of equipment qualifications involved the following:

Design Qualification (DQ)

Installation Qualification (IQ)

1 Equipment to be installed as per drawing(s)/ manufacturers

2. Equipment identification nameplate is to be visible.

3. Major components are to be securely assembled.

7. All moving parts are to be covered with suitable guard.

8. All utilities related to equipment are to be connected.

9. Parts are to be accessible for easy cleaning.

Identification of Execution Team members.

Verification of Manual, Drawing and Related documents.

RESULTS AND DISCUSSION

Description Specified Supplied

Lidding Foil Consumed / take

for base foil motor shall be ON

Power Failure Recovery Study

Machine Speed Verification:

Optimal Forming Temperature Study

Optimal Sealing Temperature

Performance of ACG inspection system

2003, volume 129, Marcel Dekker, Inc, pp. 459.

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