PERFORMANCE RE-QUALIFICATION

OF
ALU-ALU BLISTER MACHINE
NAME OF THE EQUIPMENT : Alu-Alu Blister Machine

EQUIPMENT NO. :

RQ PROTOCOL NO. :

RQ REPORT NO. :

MAKE :

CAPACITY :

LOCATION :

JSA VALIDATION SERVICES

BADDI, H.P-BHARAT (INDIA)

SOP No.: SOP-QA-044

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Alu-Alu Blister Machine

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TABLE OF CONTENTS
S. No. TITLE PAGE No.
1.0 Pre Approval 3
Overview 4-5
2.1 Purpose 4
2.0 2.2 Background 4
2.3 Responsibility 4
2.4 Equipment Description 5
Performance Re-Qualification Procedure 6 -9
3.1 Training 7
3.2 Equipment Identification 7
3.0 3.3 Verification of Performance of the Alu-Alu Blister Machine 8
3.3.1 Performance Verification at Slow Speed/High Temperature 8
3.3.2 Performance Verification at Fast Speed/Low Temperature 9
3.4 Deviation and Corrective Action 10
4.0 Acceptance criteria 11
5.0 Summary and conclusion 11
6.0 Post approval signature 12
Appendix 13
7.0 7.1 Abbreviation 13
7.2 List of Document 13
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Alu-Alu Blister Machine

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1.0 PRE APPROVAL

Activity Name Designation Department Signature

Prepared by

Reviewed by

Approved by

Authorized by
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

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2.0 OVERVIEW
The Performance Re-Qualification of Alu-Alu Blister Machine is carrying out in order to provide the
high degree of assurance that the equipment performed as intended and remain in the state of control.
2.1 PURPOSE
The purpose is to provide an outline for the Performance Re-Qualification of equipment for
performance attributes to verify that:
• The system meets the user requirement Specification.
• Document the verification that equipment performs consistently and in the state of control.
• Assure that Alu-Alu Blister Machine is adequate to support the process for which the system is
intended.
2.2 BACKGROUND
The Alu-Alu Blister Machine supplied by Rapid Pack, Equipment I.D. XXXXX installed in Alu Alu
Blister Packing Area at XYZ (Company Name). This protocol defines the methods and documentation
that shall be used to evaluate the performance attributes of Alu-Alu Blister Machine in accordance with
the user requirement specifications and intended use. The Reason for this requalification is
Periodic/Schedule Performance Requalification
2.3 RESPONSIBILITIES:
2.3.1 Quality Assurance:
• To prepare/Review and Approval of the Performance Re-Qualification protocol and report.
• To Impart the Training to the team before the execution of protocol
• To execute the Performance Re-Qualification protocol along with other department
• To monitor protocol completeness and technical accuracy.
2.3.2 User Department
• To Review of the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring performance attributes as per the protocol.
• To monitor protocol completeness and technical accuracy.
• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
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BADDI, H.P-BHARAT (INDIA)

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2.3.3 Engineering Department

• To Review the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring the performance attributes as per the protocol.
• To monitor protocol completeness and technical accuracy.
• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
2.3.4 Equipment Description
These are High-Speed Blister Packing Machines suitable for manufacturing of thermoforming blisters
with advanced motion control features. Servo motors are being used for sequencing of high-speed
operations which also enables us to have a high-speed punching operation. It has a special Pick & Place
arrangement which enables us to have direct Cartoner connectivity.
These Machines Are Working On Principle Of Thermo Forming With Vacuum Assist & Pressure
Sealing Technique. PVC/Alu Blisters Are Formed In Double Track (Depending On The Product
Layout).
The purpose of ALU-ALU packing machine is to produce blisters as per requirement of the customer.
Forming (PVC/PVDC) foil is heated by heating station and cavities are formed in the forming station.
(In case of Alu Alu it is cold forming hence heating is not required). Formed web is sealed with high
pressure and temperature. Blisters of required sizes are cut with the help of cutting tool.
Complete machine can be divided in following sub sections: -
Forming station: It consists of top plate and bottom plate to hold the format plates. Heated PVC foil is
clamped with the help of hydraulic pressure and the forming is done with the help of air. In case of Alu
Alu, foil is clamped by the hydraulic pressure and the forming is done with plugs. The opening and
closing of the station is done by the hydraulic cylinder.
Feeding station: It consists of hopper linear vibrator, rotary vibrator and the feeding parts. The product
is transferred from hopper to linear vibrator first. From linear vibrator to the rotary vibrator. Finally
from rotary vibrator to the formed cavities through filling shoe or feeding drum( in case of Alu Alu).
Sealing Station: This station consist of the top plate and bottom plate to hold the sealing plates.
Formed foil is sealed with lidding foil with the help of hydraulic pressure and the temperature. The
opening and closing of this station is done by the hydraulic cylinder. The sealing temperature is
required to be 180-200ºC depending on the format size.
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Alu-Alu Blister Machine

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Overprinting Station: it consists of Ink cartridge, pressure roller and the stereo roller. This station is
used to have a batch code printed on the foil. Ink used is DIPL 39 and thinner is DIPL 20. The mixture
of 60:40 is used for putting on the ink roller.
3.0 Performance Re-Qualification Procedure
The following procedure shall be used for performance of Alu-Alu Blister Machine:
• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Verification of performance of machine done at slow speed high temperature and fast speed and low
temperature.
• Operate the machine as per respective standard operating procedure and set the required parameter in
control panel as per product BMR.
• Record the observation in the protocol.
• Record the observations in respective section given in the protocol.
• The Performance of Alu-Alu Blister Machine shall be evaluated for minimum and maximum speed
and temperature.
• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective
action and justification report section.
• Observed deviation shall be reported to the department head and quality head.
• If the observed deviation does not have any major impact on the qualification the final conclusion
shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the
manufacturer for the corrective action and qualification activity shall be done.
3.1 Training
The qualification team member shall be trained on the protocol execution of qualification activity and
report compilation.

Sr. No. Name of Trainee Employee Code Department Sign/Date

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Name of Trainer _______________________

Trainer Sign/Date______________________
Department___________________________

3.2 EQUIPMENT IDENTIFICATION

Description Specification Observation Remark

Equipment Name Alu-Alu Blister Machine

Model RP MACH-1+

I.D. No. PR/EQP/044

Sr. No. M1/013/015

Name of the Supplier Rapid Pack

Equipment Location

Facility Oral Dosages Facility

Area Alu-Alu Blister Packing Area

Checked By: Sign/Date Verified By: Sign/Date

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BADDI, H.P-BHARAT (INDIA)

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3.3 VERIFICATION OF PERFORMANCE OF THE ALU-ALU BLISTER MACHINE

3.3.1 PERFORMANCE VERIFICATION USING SLOW SPEED AND HIGH TEMPERATURE

PRODUCT NAME__________________________________________________

BATCH NO.______________________________________________________

Parameters Acceptance Criteria Observations

Slow Speed/High Temperature

Slow Speed of Alu-Alu To be recorded
Blister Machine
High temperature To be recorded
Pocket of Blister should be
Cavity/pocket Formation
smooth and defect free.
Tablet feeding should be smooth
Tablet feeding
and proper during operation.
Sealing Quality of Blister should
Sealing Quality
be good.
Over coding on Blister should be
Over coding
readable and proper.
Cutting of Blister should be
Cutting of Strips
proper.
Leak test should be passed on
Leak Test
sampled Blister.
Physical Appearance of Blister
Physical Appearance
should be good.

Checked By: Sign/Date Verified By: Sign/Date

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Alu-Alu Blister Machine

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3.3.2 PERFORMANCE VERIFICATION AT FAST SPEED/LOW TEMPERATURE

PRODUCT NAME__________________________________________________

BATCH NO.______________________________________________________

Parameters Acceptance Criteria Observations

Fast Speed/Low Temperature
Fast Speed of Alu-Alu To be recorded
Blister Machine

Low temperature To be recorded

Pocket of Blister should be

Cavity/pocket Formation
smooth and defect free.
Tablet feeding should be smooth
Tablet feeding
and proper during operation.
Sealing Quality of Blister should
Sealing Quality
be good.
Over coding on Blister should be
Over coding
readable and proper.
Cutting of Blister should be
Cutting of Strips
proper.
Leak test should be passed on
Leak Test
sampled Blister.
Physical Appearance of Blister
Physical Appearance
should be good.

Comments:…………………………………………………...….……………………..………………
………………………………………………………………………………………………………

Checked By: Sign/Date Verified By: Sign/Date

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

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3.4 DEVIATION AND CORRECTIVE ACTION

Description of deviation and date observed

Person responsible for corrective action and date assigned

Corrective action taken and date conducted

Checked by: __________________ Date: ____________________

Verified by: ___________________ Date: ____________________

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BADDI, H.P-BHARAT (INDIA)

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4.0 ACCEPTANCE CRITERIA

Performance Re-Qualification of Alu-Alu Blister Machine shall be considered acceptable when
requirements listed in section 3.0 of this protocol has been fulfilled and all the components of Alu-Alu
Blister Machine are performed as per the user requirement specifications.

5.0 SUMMARY AND CONCLUSION

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6.0 POST APPROVAL SIGNATURE

Activity Name Designation Department Signature

Executed by

Reviewed by

Approved by

Authorized by
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

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7.0 APPENDIX
7.1 ABBREVIATIONS

Sr. No. : Serial number

RPM : Rotation per minutes

SOP : Standard operating procedure

Kg : Kilogram

NMT : Not more than

S.S. : Stainless Steal

cGMP : Current Good manufacturing Practice

I.D. No. : Identification number

7.2 LIST OF DOCUMENTS

Annexure No. Name of Annexure

END OF DOCUMENT