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Performance Qualification for Automatic Strip Packing Machine

Performance Qualification for Automatic Strip Packing Machine

TABLE OF CONTENTS

1.0 Approval
2.0 Objective
3.0 Responsibility
4.0 System Description
4.1 Equipment Identification
4.2 Description of Operation
4.3 Standard Operating Procedure Established During Operation Qualification
5.0 Validation Plan and Methodology
6.0 Performance Qualification Procedure
6.1 Effect of Sealing Temperature
6.2 Effect of Sealing Temperature
6.3 Effect of Vibration
7.0 Deviation and Corrective Action
8.0 Change Control Proposal
9.0 Re-validation Criteria
10.0 Acceptance Criteria
11.0 Evaluation and Result
12.0 Conclusion
13.0 Appendix
13.1 Abbreviations
13.2 Reference
13.3 Annexures

Approval

Prepared By

Signature

Date

[Officer Production]

 

Checked By

Signature

Date

Executive – QA

Manager – Engineering

Manager – Production]

 

Authorized By

Signature

Date

Head – Quality Assurance

Objective:

Objective of this protocol is to collect sufficient data to establish that Automatic Strip Packing Machine, supplied by M/s. Rapid Pack Engineering Pvt. Ltd. performs to meet the desired Product Quality in consistent manner, when operated as per Standard Operating Procedure.

Performance Qualification Protocol shall provide the Methodology of qualification studies, formats for recording the observation, Criteria of Qualification and a guideline for documentation of the study.

Responsibility:

The validation group comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:

  • Production Department
  • Quality Assurance Department
  • Quality Control Department

The Production department shall be responsible for checking the operations and recording data as per the procedures outlined in the data sheets of this protocol. The Quality control department shall be responsible for testing of samples wherever required.

The Protocol of Performance qualification shall be initiated and Checked by Production Department. The report shall be finally authorized by GM operation and Quality Assurance head.

System Description:

The Strip Packing Machine is designed for packing of Tablet and Capsule within two heat sealable foil. The machine has been designed to use cellophane Film, Cellophane Lumithene, Aluminum Foil, Polythene Film Laminates and all heat sealing papers for sealing purpose.

The Tablet / Capsules are charged into the hopper. Tablets / Capsules are automatically fed to vibrating bowl. Individual Tablets passes vertically through chute provided and are enclosed between pockets formed by two plies of film. These two films are heat sealed when pass through the sealing roller. These rollers are provided with heaters.

Horizontal cutting of the strip is done by the knife and vertical cutting is done by vertical cutter.

The major component of the equipment are identified us:-

  • Feeding System
  • Sealing System
  • Batch Coding Unit
  • Cutting System

Feeding System:-Product is fed into the hopper from where it is guided into the Bowl mounted on a Vibrator. The product on the bowl is evenly distributed and guided through the Tracks on the Bowl into the Chute Channel and the feed rate of the product from the Bowl to the Chute channel is controlled by the vibrator. The Product from the chute is released onto the Sealing Roller by the Cam Operated Released Pin.

Sealing System: – The set of Sealing Rollers drawn the heat sealing Packing Material from two set of front adjustment type of friction brake system Foil holding Assembly and Foil Running Tube. The Sealing Roller is are heated to the required temperature by the Cartridge Heaters inserted into the individual Roller. Adequate pressure is applied onto the Sealing Rollers so that both the foil get sealed at the time of contact while passing through the Sealing Roller. At this stage the product which is released onto the cavity of the Roller gets packed and sealed in the foil.

Batch Coding Unit:- The left hand foil before being drawn by the Sealing Rollers passes through the Batch Coding Unit where the Batch No., Mfg. Dt., Exp. Dt. Etc is printed on the foil.

Cutting System:- The packed and sealed strip from the sealing roller passes through the Brush and Slitter Shaft which cuts the Strips vertically. These vertically cut strips then passes through the Cam operated Cutter assembly which cuts the Strip Horizontally into the desired Strip Length. The desired Strip Length can be achieved by using the appropriate Cutting Gear and Toe Cams.

The machine equipped with basic drive unit controlled by Servo Drive. Linear- Indexing servomotor is controlled by servo- drives. A freely Programmable Logic Controller, interfaced with digital display unit (Man-Machine Interface), controls the multiple functions on the machine.

The PVC, PVDC and ALU-ALU cold forming film can be used as Forming / Base film, in which blister cavities are formed by compressed air and mechanical pressure.

Draw the forming film from the forming reel feed and passes between the Forming die & blow head through forming heating platen in case of thermo-formable material and forming tool in case ALU-ALU cold forming foil (Change Part) through the dancing arm to the linear indexing station via forming, sealing Station, Perforation Station.

The movement of unwinding of forming film draw motor is controlled by proximity switch for start of the unwinding and stop of the unwinding of the foil from the reel feed.

This blister formed web moves over the web guide track and at this station the products are fed into the blisters through individual feeding devices. The formed web along with the tablet or capsules moves to the sealing station, where it is fused to the aluminium foil, which has been drawn from an aluminium reel – feed station. That printed sealed web is transferred to mechanically driven perforation station (If Applicable) through Linear Indexing. The punching tool punches out the specified pack, which is transferred to the out feed conveyor.

The waste web is then transferred to the trim winding station passing over the dancing arm and guide rollers where the trim is wound on the trim-winding roller.

All the operational controls and sequences of the machine are arrayed by Man- Machine Interface (MMI) which is conveniently located in front of the machine and rotary encoder, which determines the positional accuracy of the machine with the feedback.

All parametric changes can be done with controls through the Man-Machine- Interface, which has multiple levels of password protection.

Products to be packed on the machine are specifically pharmaceutical products such as Tablets and Capsules. Different types of product can be fed into the blister formed cavities on the formed web over the web guide track at the feeding zone.

The output capacity of the machine depends upon the product characteristics like size and shape of the products and on the type of feeding device.

Equipment Identification

The subjected equipment is identified as Automatic Strip Packing Machine

The Equipment is identified as : Automatic Strip Packing Machine
Model No. : RP MACH-1 TURBO
Serial No. : RPT/11/004
Eq.ID. :
Name of the Supplier : Rapid Pack Engineering Pvt. Ltd.
Purchase Order Number / Date : SCT/PUR/19-20/162, Dated: 21/115/2019

Description of Operation:

The Strip Packing machine is designed for sealing tablets / capsules in leak proof Aluminum strips having one tablet / capsule in each pocket so that it can resist variation in temperature and humidity. Proper sealing is achieved through controlled heat and pressure to seal the strips.  

Standard Operating Procedure established during Operation Qualification

Operation of Strip Packing Machine: __________________________________

Operation of Leak Test Apparatus: ____________________________________

Cleaning of Strip Packing Machine: ___________________________________

Preventive Maintenance of Strip packing Machine: _______________________

Validation Plan and Methodology

Performance of the Strip Packing Machine shall be tested by varying the Critical Process Variables.

Critical Process Variables are:

  • Machine Speed
  • Vibrator Speed
  • Sealing Temperature

Equipment Performance Qualification shall be carried out, simulating actual production conditions and varying minimum & maximum critical process variable conditions.

No pharmaceutical active Ingredients shall be used for the qualification purpose. Placebo tablets used for manufacturing of routine products shall be used for the study.

Packing of tablets / capsules shall be done as per the respective Standard Operating Procedure. Foil is to be checked for leakage, knurling impression, punctures, empty pockets and proper coding.

·     Standard Operating Procedures Reference No.:

·     Dispensing of Packing materials: – _______________________

·     Operation of leak Test apparatus: – _______________________

·     Operation of Strip Packing Machine ______________________

Minimum three trials shall be carried out for each process variable at three points, to verify proper sealing of strips. In addition, during the performance qualification study, the operating range of temperature for sealing roller heater, machine RPM and vibrator speed should be checked. The foil taken for trial batches is of ___________mm. width ________mm. thickness.

Validation Plan is described in the following Matrix.

Process Variable Parameter selected for qualification Number of trials Quality Parameters to be tested Sampling frequency
Machine Speed

(Cut/min.)

15 3 1.      Knurling

2.      Leak test

3.      Batch Coding

4.      Tablets/Pocket

Strip packs from one complete revolution at start and end of operation.
30 3
50 3
Sealing Temperature

(°C)

120 3 1.      Knurling

2.      Leak test

3.      Batch Coding

4.      Tablets/Pocket

Strip packs from one complete revolution at start and end of operation.
140 3
160 3
Vibrator Speed Slow 3 1.      Knurling

2.      Leak test

3.      Batch Coding

4.      Tablets/Pocket

Strip packs from one complete revolution at start and end of operation.
Medium 3
Fast 3

Performance Qualification Procedure:

Test Data Sheet

Date: ……………..        Time: ……………..

Effect of machine speed:  

S. No. Machine Speed

(Cuts / Min.)

Sealing Temp.

(°C)

Vibrator Speed Description
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.

 Remarks (if any): 

Data Entered By: __________________ _________________ _____________
  [Name] [Signature] [Date]
       
Verified By: __________________ _________________ _____________
  [Name] [Signature] [Date]

6.2      Effect of Sealing Temperature:  

Test Data Sheet

Date: ……………..            Time: ……………..  

S. No. Sealing Temp. (°C) Machine Speed

(Cuts / Min.)

Vibrator Speed Description                              
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.
 

 

 

 Remarks (if any):

 

Data Entered By: __________________ _________________ _____________
  [Name] [Signature] [Date]
       
Verified By: __________________ _________________ _____________
  [Name] [Signature] [Date]

 Effect of Vibration:  

Test Data Sheet

Date: ……………..      Time: …………….. 

S. No. Sealing Temp. (°C) Machine Speed

(Cuts / Min.)

Vibrator Speed Description                              
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.
 

 

 

  Remarks (if any): 

Data Entered By: __________________ _________________ _____________
  [Name] [Signature] [Date]
       
Verified By: __________________ _________________ _____________
  [Name] [Signature] [Date]

7.0       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: ____________________

Change Control Proposal

Sr. Change Observed / Made Reason Verified By (Production)

Sign & Date

Approved By (Q.A.)

Sign & Date

Re-Validation Criteria

           Performance Qualification of Strip Packing Machine to be Re-Validated on:

  • Substitution of existing Strip Packing Machine with a new Strip Packing Machine.
  • Replacement of existing instrument / component with a new one, which can have a direct impact on the performance of the Strip Packing Machine.
  • Any major modification to the existing Strip Packing Machine which can effect the performance of the equipment.
  • If the Strip Packing Machine is found to be malfunctioning during performance qualification.

Acceptance Criteria    

  • Performance Qualification shall be considered acceptable when all the conditions specified in respective data sheets are completed and optimum process conditions are finalized, with simulating actual production conditions and varying minimum & maximum critical process variable conditions.
  • Any deviation from the acceptance criteria of the specific check point shall be reported and decision will be taken for the rejection, replacement or rectification of the equipment/component
     Evaluation of Result:

Results shall be documented in Test Data Sheets based on the observations recorded in Performance Qualification. Evaluation of results shall be carried out by finalising the operational range of equipments for processing of products. All test results meeting the Acceptance Criteria shall establish the satisfactory performance of Strip Packing Machine Eq. ID _____________________ when operated as per SOP No. __________________________

Conclusion:

On the basis of evaluation of results it can be concluded that the Strip Packing machine Eq. ID _________________ supplied by M/s. Rapid Pack Engineering Pvt. Ltd is adequate to provide the strip packing of tablets and capsules, meeting the desired quality parameters in consistent manner.

Appendix

Abbreviations 

Min          –           Minutes
PQ            –           Performance Qualification
SOP         –           Standard Operating Procedure
QA           –           Quality Assurance

 References

Protocol Format and style guide – FDA guidelines

Annexure

Not Applicable

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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