OPERATIONAL QUALIFICATION PROTOCOL No.

:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

S.No. ITEM DESCRIPTION PAGE No.

1.0 PROTOCOL APPROVAL 2
2.0 OVERVIEW: 3
2.1 Objective 3
2.2 Purpose 3
2.3 Scope 3-4
2.4 Responsibility 5
2.5 Execution Team 6
3.0 ACCEPTANCE CRITERIA 6
4.0 REVALIDATION CRITERIA 6
5.0 OPERATIONAL QUALIFICATION PROCEDURE 7
5.1 Equipment Description 7-9
5.2 Instruction for Filling the Checklist 10
5.3 Verification of Calibrated component 11
5.4 Test Instrument Details 12
5.5 Verification of functional checks 13-19
5.6 Verification of safety features 20
5.7 Verification of supporting utilities 21
5.8 Verification of Standard Operating Procedure 22
5.9 Training Record Of Personnel (S) 22
5.10 List of annexure 23
5.11 Deficiency And Corrective Action(s) Report(s) 24
6. 0 OPERATIONAL QUALIFICATION FINAL REPORT 25
6.1 Summary 25
6.2 Conclusion 25
6.3 Final report approval 26
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

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 Operation Qualification protocol of Blister pack machine has been reviewed and approved by the
following Persons

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PREPARED QUALITY
BY ASSURANCE

QUALITY
ASSURANCE
REVIEWED
ENGINEERING
BY

PRODUCTION

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE
[
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

2.0 OVERVIEW:

2.1 OBJECTIVE:

The objective of developing and executing this protocol is to collect sufficient data pertaining to the
Blister pack machine and define the qualification requirements and acceptance criteria for the
machine and to prove that each operation proceeds as per design specification and the tolerances
prescribed there in the document, are the same at utmost transparency.
The Qualification of Blister pack machine performed in view of Soft gel Blister packing area of
manufacturing facility.

2.2 PURPOSE:

The purpose of this protocol is to establish documentary evidence to ensure that the Blister pack
machine received matches the Design specification and also to ensure that it is properly and safely
installed.

2.3 SCOPE:

The Scope of this protocol is limited to the operational Qualification of Blister pack machine in
Soft gel Blister packing area of manufacturing.
Once the operational qualification of Blister pack machine has been completed successfully, the
equipment shall be preceded for the performance qualification procedure.

2.4 RESPONSIBILITY:

In accordance with protocol, following functions shall be responsible for the qualification of
system.

Execution Team (Comprising members from Production, Engineering and Quality

Assurance) and their responsibilities are following:
 Prepares the qualification protocol.

 Ensures that the protocol is in compliance with current policies and procedures on system
Qualification.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

 Distributes the finalized protocol for review and approval signatures.

 Execution of Qualification protocol.

 Review of protocol, the completed qualification data package, and the final report.

 The operational checks, calibration, SOP verification, verification of safety features,

verification of utility supply shall be carried out by engineering persons and production
person.
 The production operator / supervisor shall carry out the cleaning and operation of machine.

Head – Production/ Engineering:

 Review of protocol, the completed qualification data package, and the final report.

 Assist in the resolution of validation deficiencies.

Head – Operation and Quality Assurance:

 Review and approval of protocol, the completed qualification data package, and the final
report.

2.5 EXECUTION TEAM:

The satisfactory operation of the Blister pack machine shall be verified by executing the qualification studies
described in this protocol. The successfully executed protocol documents that the Blister pack machine is
operational and is satisfactorily working.
Execution team is responsible for the execution of Operational Qualification of Blister pack machine.
Execution team comprises of:

NAME DESIGNATION DEPARTMENT SIGNATURE DATE

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

3.0 ACCEPTANCE CRITERIA:

3.1 The equipment shall be operational as per its specified operating instructions.

3.2 All SOPs for the equipment shall be verified and checked.

3.3 All material of constructions of the contact parts to be checked as per the specifications.

3.4 All the functionality of equipment components to be checked.

3.5 All the safety features of the equipment shall be verified and utilities shall be available near the
equipment.

3.6 The validity of the calibration of tests instruments shall be checked and all the required
calibration of the components of the equipment shall be performed.

4.0 REVALIDATION CRITERIA:

The machine has to be revalidated if

 There are any major changes, which affect the performance of the equipment.

 After major breakdown maintenance is carried out.

 As per revalidation date and schedule

5.0 OPERATIONAL QUALIFICATION PROCEDURE

5.1 EQUIPMENT DESCRIPTION:

Equipment Name : Blister packing machine

Supplier / Manufacturer : Elmach Packages (India) Pvt. Ltd.

Dimension (LXWXH) : 3480 mm X 1100 mm X 2180 mm

Model : EPI 2500

Serial no. : 2606

Base film : Thermo-formable, bi-axially oriented, non- toxic pvc,

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
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PHARMA DEVILS

pvc with pvdc coating.

Lidding material : Hard tempered Aluminium foil with heat sealable coating

PVC base film width : 212 mm (Max)

PVC film thickness : 0.25 mm to 0.30 mm

PVC reel diameter : 440 mm (Max)

Aluminium foil width : 208 mm (Max)

Aluminium foil thickness : 0.02 mm to 0.03 mm

Aluminium reel diameter : 220 mm (Max)

Format area : Min 25 MM X 196 MM

Max 102 MM X 196 MM

Advance length : 110 mm (Max)

Punched out pack length : 204 mm (Max)

Punched out pack width : 110 mm (Max)

Output : Max 140 strokes / min (Depend on the Product).

Air Pressure Required : Minimum 6 bar (Kg/cm2)

Cooling water Flow Rate : 2 lit / min. at 13 ºC to 16 ºC

Location : Blister packing area II

Blister packing machine comprises of following components.

1. Hopper
2. Vibrator
3. Forming Roller (Assembly )
4. Feeding Box
5. Web guide track
6. Sealing Roller (Assembly)
7. Guide roller
8. Machine panel & cover
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

9. Trim chute
10. Embossing Unit
11. Perforation Unit
12. Pack pick and place assembly
13. Batch Code printing unit
14. Punching station
15. Conveyer belt
16. Emergency switch
The Blister packing machine EPI –2500 is an automatic blister packing machine utilized for packing of

tablets in blister packs. The EPI 2500 machine draws PVC base film from a reel feed assembly in to the

forming station, where blister are continuously formed. The formed web moves over the guide track to the

feeding station. Here using a suitable feeding attachment, product is automatically filled in the blister

cavities. Filled web moves to the sealing station. Lidding material, drawn from the reel stock, is feed to the

sealing station. Lidding material gets sealed with the filled web enclosing the product hermetically (airtight

closure protecting the product from outside contaminates). The filled and sealed web is fed by an indexing

mechanism into the pack punching station. Here, the web gets punched into the packs as per layout. The

blister pack are either collected in bins or transferred on a conveyor belt and conveyed for further handling.

The trim waste is sheared off into small pieces for easy handling and disposal.

All the operational controls and sequences of the machine are arranged by Man-Machine Interface mounted

conveniently located in front of the machine and mechanical cams, which determines the positional

accuracy of the machine with the feed pack.

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.2 INSTRUCTION FOR FILLING THE CHECKLIST

5.2.1 In case of the compliance of the test actual observation should be written in specified location.

5.2.2 For identification of the components of the equipment and utilities actual observation should be
written in specified location.

5.2.3 Give the detailed information in the summary and conclusion part of the Operational
Qualification report.

5.2.4 Whichever column is blank or not used ‘NA’ shall be used.

5.3 Verification of Calibrated component :

This test is intended to describe the equipments/instruments and its complete details to have
traceability to the national standard, which is to be used for the verification of the operation of the
Blister pack machine.
Calibration Calibration Certificate
S.No. Name of Instrument Inst. ID. Number
done on valid up to number

Remarks:
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----------------------------------------------------------------------------------------------------------------------------------

Done By & Date: Verified By & Date:

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.4 Test instrument calibration:

Review the calibration status for the test instrument to be utilized in operational qualification testing and
record the calibration due dates in the table below. All equipment / instrumentation must remain within the
calibration due date for the duration of OQ test for which the item is used. If a due date potentially occurs
during the testing period then the instrument must be recalibrated before it can be utilized.
Calibration done Calibration Due Calibration
S.No. Test Instrument ID
Date Date Certificate No

Remarks:
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Checked By/Date: Verified By/Date:
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.5 VERIFICATION OF FUNCTIONAL CHECKS:

Method of Checked
Name of system
Specified function verification Observation By
component
Sign/Date
Check correct working of The machine should be Physically by
the machine operational. challenging

Hopper Visually
To charge the Tablet

Vibrator Visually
To produce vibration
so that tablets come in
the feeding channel
easily
Feeding channel Visually
To collect the tablets

Operating panel To operate the machine Visually

through the switches
Forming roller Visually
Formation of pockets
with the aid of vacuum
Sealing roller Visually
The seal the
Aluminium foil with
the base foil.
Punching Station Visually
For proper cutting of
the packs from the web
as per layout
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

Method of Checked
Name of system
Specified function verification Observation By
component
Sign/Date
Uniformity of sealing of the Physically by
formed web with the challenging
lidding material:
1. Place a carbon paper in
between two plain paper
sheets & place them over Uniform impression of
the counter sealing roller. the counter sealing die
and knurling of the
2. Stick them with an pressure Sealing roller
adhesive tape to the counter on the paper is
sealing roller. Press the start observed.
push button for pressing the
papers between pressure
sealing roller and counter
sealing roller. Repeat the
test using the web and the
lidding material.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

Method of Checked
Name of system
Specified function verification Observation By
component
Sign/Date
Base foil splice detection: Filled and sealed web Physically by

1. Splice the end of with spliced base foil challenging

preceding base foil with the is punched into blister

end of succeeding base foil packs & splice pack

an adhesive tape & start the are rejected.

machine

Lid foil splice detection: Filled and sealed web Physically by

1. Splice the end of with spliced lid foil is challenging

preceding lid foil with the punched into blister

end of succeeding lid foil packs & splice packs

an adhesive tape & start the are rejected.

machine
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

Method of Checked
Name of system
Specified function verification Observation By
component
Sign/Date
Overprinting arrangement: Physically by
1. Mount Batch code challenging
printing drum.

2. Mount the stereo types Batch code printer

over the drum. stereos are on the
roller, in the position
as described
3. Put a mixture of ink and
thinner over inking roller Drum and inking roller
and engage the roller are engaged.
against the drum.

4. Press the start push

button. No smudging of ink
and no shifting of
printing are observed.
Forming & Sealing & Physically by
Perforation temperature challenging
controllers:
1. Switch on the
Temperature control is
temperature controller & set
‘ON’, temperature is
the temperature at between
set & remains within
0 0
145 C & 160 C. Run the
the set value
machine
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

Method of Checked
Name of system
Specified function verification Observation By
component
Sign/Date
Cooling water temperature: Physically by
challenging
Press the start push button
& switch off the cooling of
Initially machine starts
the water cooler.
& when cooling water
temperature exceeds
the set value, the
machine stops

Remarks:_______________________________________________________________________________
______________________________________________________________________
______________________________________________________________________________

Done By & Date: Verified By & Date:

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.5.1 Verification of Operational Checks:

Test Acceptance Criteria Method of verification Observation

Switch `ON’ Power supply should be on By Challenging
Switch `OFF’ Power supply should be off By Challenging
Speed control with Control the machine speed with Physically by
rotating knob knob challenging

Forming heater indicator Indication shall glow when start Physically by

the forming heater. challenging
Sealing heater indicator Indication shall glow when start Physically by
the sealing heater. challenging
Green start push buttom Machine should start. Physically by
challenging
Red stop push button Machine should stop. Physically by
challenging
Feeder motor Speed Control the feeder motor speed Physically by
controller challenging
Aluminum foil Speed Control the aluminum foil motor Physically by
controller speed challenging
Vibrator Switch for auto / Vibrator should start in auto / Physically by
manual manual mode challenging
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

Name of system Specified function Method of Observation

component verification
Machine speed Set the machine On various speed like 40 On controller
,60,80 and 100 cuts / minute display
Forming roller To indicate the temperature of Forming
temperature roller .Set the roller temperature at various
Display check
indicator temperature like 120ºC , 160 ºC 180 ºC and
record the same
Sealing roller To indicate the temperature of Sealing roller
temperature .Set the roller temperature at various
Display check
indicator temperature like 180 ºC , 200 ºC, 220 ºC
and record the same
Power failure test Machine shall be set at different
temperature of sealing and forming
temperature and shut down for 3 minute and Display check
again restart the machine, The set parameter
should not change.

Remarks:

______________________________________________________________________________

______________________________________________________________________________

Done By & Date: Verified By & Date:

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.6 VERIFICATION OF SAFETY FEATURES:

Safety Method Verified

Features of Acceptance Criteria Observation By
Description Verification Sign/Date
No PVC film Remove the PVC and The machine should not
start the machine. start.
Emergency stop Run the machine &
Press the emergency The machine should stop
stop push button. immediately.
Check whole body
No current leakage
Earthing with multimeter for
should be observed.
any current leakage.

Remark: --------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------

Reviewed by (Sign/Date)
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.7 VERIFICATION OF SUPPORTING UTILITIES:

Utility Method of Observation Verified

Verification By
Sign/Date
Electricity: 3 phase, 415V By challenging
AC, 50Hz supply with with clamp meter
neutral and proper earthing
Compressed air Physically
2
6 kg/cm

Chilled water line Physically

13 to 16 °C

Remark: -------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------
Reviewed by (Sign/Date)

5.8 VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)

The following Standard Operating Procedures were identified as important for effective performance of
Blister pack machine

S.No. SOP Title SOP Verified By

Number (Sign/Date)

Remark: --------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
Reviewed by (Sign/Date)
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.9 TRAINING RECORD OF PERSONNEL (S):

S.No. Name of Personnel Designation Sign. & Date Trained By Remark

Remark: --------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
Reviewed by (Sign/Date)

5.10 LIST OF ANNEXURES:

Annexure No. Document Title

Remarks (if any):

______________________________________________________________________________________
__________________________________________________________________

Done By & Date: Verified By & Date:

 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

5.11 DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S):

Following deficiency was identified and corrective actions taken in consultation with the Engineering
Department.

Description of deficiency:

Corrective action(s) taken:

Deviation accepted by Deviation Approved by

(Sign/Date) (Sign/Date)
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

6.0 OPERATIONAL QUALIFICATION FINAL REPORT:

6.1 SUMMARY:

6.2 CONCLUSION:

Prepared By Checked By
Sign/Date Sign/Date
 OPERATIONAL QUALIFICATION PROTOCOL No.:
FOR
BLISTER PACKING MACHINE

PHARMA DEVILS

6.3 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. If applicable
Signature in the block below indicates that all items in this Operational qualification report of Blister pack
machine have been reviewed and found to be acceptable and that all variations or discrepancies have been
satisfactorily resolved.

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

QUALITY
ASSURANCE
REVIEWED
ENGINEERING
BY

PRODUCTION

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE