Blister pack line validation protocol

by ·

 

Blister pack line validation protocol- ALU/PVC

  1. Objective :

         To validate the packing process of the product on the Blister Pack line.

 

  1. Scope :

Applicable to Blister Packing of tablets.

 

 

  1. Principle :

 

  1. For EPI 2500 : The machine draws PVC base film from the reel feed assembly into the blister forming station where by applying heat and vacuum on the sealing roller over the guide track on which the product is automatically filled in with a suitable feeding attachment and then enters into the sealing station where the Aluminum film is also drawn from the reel stock & fed to the sealing station where it seals with the base PVC web thereby sealing the product hermetically. The filled & sealed web is then fed by an indexing mechanism into the pack punching station where the pack are separated from the web in desired size.

 

  1. CARTONATOR :

The pre-glued cartons are locked into magazine and transferred to the forming station. At the same time the product to be packaged reaches it along a feed belt. After the carton is formed and opened, a punch applies a mark on the side opposite to the operator  or the side operator, and then the product and the instructions leaflet picked up from the suitable magazine are inserted into the opened carton. The carton is closed as the edges are trucked in by suitable devices.

 

 

 

 

 

  1. CONDOT PRINTER / INK JET PRINTER :

Works on the principle of thermal inkjet technology by placing small ink drop on carton.

 

  1. CHECK WEIGHER:

The load cell on check weigher is connected to pusher through PLC , when the weight of the carton is found out of limit the pusher will push the carton in the rejection box with the help of compressed air.

 

  1. SHRINK WRAP MACHINE: (If applicable)

When film wrap product goes through tunnel, horizontal vent will flow hot air   through chamber on the product.

 

 

  1. Justification: To be recorded in validation report.

 

 

  1. Site of study:

 

Pharma packing

 

 

  1. Responsibility:

Production

Quality Assurance

Engineering

(Individuals name to be recorded in validation report)

 

 

 

 

  1. Description of equipment to be used:

 

  • BLISTER PACK MACHINE (EPI 2500)
  • CARTONATOR
  • INK JET PRINTER / CONDOT
  • CHECK WEIGHER
  • SHRINK WRAP MACHINE (IF APPLICABLE)
  • SHIPPER WEIGHING BALANCE

 

Note : 1.  Code No. of above mentioned equipments should be recorded in the validation  Report.

 

 

  1. Equipment Qualification date should  be recorded in the validation Report.

 

 

 

 

 

 

 

 

 

  1. Standard Operating Procedure (SOP) to be followed:

Packing of the Product done as per Packing procedures.

(Details to be recorded in the validation Report)

 

  1. Standard Operating Procedures (SOP) for blister pack machine:

(Details to be recorded in the validation Report)

 

  1. Standard Operating Procedures (SOP) for operating Cartonator:      (Details to be recorded in the validation Report)

 

  • Standard Operating Procedures (SOP) for operating Ink Jet / Condot Printer: (Details to be recorded in the validation Report)

 

  1. Standard Operating Procedures (SOP) for operating Check weigher:               (Details to be recorded in the validation Report)

 

  1. Standard Operating Procedures (SOP) for operating Shrink wrapping machine (if applicable): (Details to be recorded in the validation Report)

 

 

  1. Standard Operating Procedures (SOP) for operating Shipper weighing balance: (Details to be recorded in the validation Report.

 

  1. Batch packing record (BPR) to be followed:

Product Name: To be recorded in validation Report,

Batch no: To be recorded in validation Report and

Pack code: To be recorded in validation Report.

 

 

  1. Controls:

A.    Requirements:

  1. Blister Pack Machine:
    1. Blister Pack machine speed.

(Details to be recorded in the validation Report.

  1. Temperature of film Heater and Sealing Roller.
  • Ambient temperature under which packing operation of the product under study is carried out should be 22± 30C

 

 

  1. Cartonator :
    1. Working of Carton Level Detector, Enclosure Detector, Product Sensor.
    2. Vacuum pressure should be NLT 50 Psi,
  • Functioning of Pharma code reader.

 

 

 

 

  • Ink Jet Printer / Condot Printer:
    1. The printer must be adapted to production line.
    2. The printer must be initialized.
  • Access Code.
  1. Sensor for sensing the carton should be kept “ON”

 

 

 

 

 

  1. Check Weigher System :
    1. Sufficient compressed air pressure should be kept at carton blow station (NLT 4 bar)
    2. Conveyor speed.
  • During validation ensure that pack with carton improper content should be rejected and same should be ensured.
  1. Optical Sensor to Detect the product.
  2. Pressure switches to ensure that Machine does not Operate in case of low Pneumatic pressure.

 

 

 

 

  1. Shrink Wrapping Machine :

During validation it is observed that wrapping of shrink must be done properly.

 

 

 

 

 

  1. Shipper Weighing Balance :

During validation ensure that shipper with improper count should be rejected and same should be ensured.

 

 

  1. Calibrations:

 

Calibrated Vacuum Pressure gauge.

(Detail to be recorded in the validation Report.

 

 

Ensure that the balance are calibrated before starting the experiment.

Date of Calibration done to be recorded in the validation Report.

 

 

Calibrated Compressed Air Pressure gauge.

(Detail to be recorded in the validation Report).

 

 

 

Calibrated Temperature Controller.

(Detail to be recorded in the validation Report).

 

 

 

  1. Training :

 

Trained personnel (Details to be recorded in the validation Report).

 

  1. Precautions :

 

Safety aspects while operation of the machine must be ensured.

 

  1. Validation Procedure:

 

  1. Blister Pack Machine:

     Instructions for checks:

 

  1. Operate the Blister Pack machine as per SOP. (Includes setting of Camera ).
  2. Perform the leak test on blister / combipack at Initial & every 4 hour or machine is idle for more than 30 minute or change in A.R. No. of Aluminum foil. (If machine will run NMT One hour perform at Initial, End).
  • Observe and record the temperature of film Heater  roller and sealing roller at Initial & every 1 hour. (if machine will run NMT One hour perform at Initial & End).
  1. Check the following at Initial & every 1 hour. (If machine will run NMT One hour perform at Initial & End).
    1. Pin holes
    2. Knurling Uniformity
    3. Wrinkles
    4. Break Test (For combipack) / Scoring
    5. Leak Test
    6. Loop sensor functioning.
      1. Check the performance of Camera system at Initial & every 1 hour. (if machine will run NMT One hour perform at Initial & End).
        1. Remove one tablet from any one of the blister pocket of the PVC foil web filled with tablets as given in the diagrammatic representation.
        2. Observe that the audio alarm system is operated each time, record the same.
        3. Check whether the non-filled pack is rejected and falls in the rejection. Record the same.
        4. Check whether any filled pack is not rejected. Record the same.
        5. Insert a half tablet in any one of the blister pocket, observe whether audio system is operated. Record the same.
        6. Check whether the non-filled pack is rejected and falls in the rejection. Record the same.
        7. Perform this procedure for clear, amber and opaque Blister.
        8. Send empty blister strip, Observe that the audio alarm system is operated each time, record the same

 

  1. Set the machine at lower speed as per the product SOP

 

  1. a) Increase the temperature of film heater plate and sealing roller and do the following test.

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring
  5. Leak test.
  6. Embossing /Overprinting
  7. Loop Sensor functioning

 

 

  1. b) Decrease the temperature of film heater plate and sealing roller and do following test

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring
  5. Leak test.
  6. Embossing / Overprinting
  7. Loop Sensor functioning

 

  • Set the machine at Higher speed as per the product SOP

 

  1. a) Increase the temperature of film heater plate and sealing roller and do following test

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring
  5. Leak test
  6. Embossing / Overprinting
  7. Loop Sensor functioning

 

  1. b) Decrease the temperature of film heater plate and sealing roller and do following test

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring.
  5. Leak test
  6. Embossing / Overprinting
  7. Loop Sensor functioning

 

 

  • Set the machine at optimum speed as per the product SOP.

 

  1. a) Increase the temperature of film heater plate and sealing roller and do following test

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring
  5. Leak test
  6. Embossing / Overprinting
  7. Loop Sensor functioning

 

  1. b) Decrease the temperature of film heater plate and sealing roller and do following test

 

  1. Pin holes
  2. Knurling Uniformity
  3. Wrinkles
  4. Break Test (For combipack) / Scoring.
  5. Leak test
  6. Embossing / Overprinting
  7. Loop Sensor functioning

 

  1. Cartonator

Following are the tests to be carried out:

  1. Operate the cartonator as per SOP.
  2. Set the width of Blister to be released from the Blister / Cell.
    1. No Blister in the Blister cell.
    2. Leaflet below sensor level in the leaflet magazine box.
    3. Carton below sensor level in the carton magazine box.
    4. Remove 5 cartons after closing of flap, check the quality of carton at the end for proper closing, embossing / printing and insertion of Enclosure. Check at Initial & every 1 hour. (if machine will run NMT One hour perform at Initial & End).
    5. Check the interlocking of following one by one for Emergency off, Guards open, Hand wheel, No carton, No leaflet, pusher overload, No product, Loading Safety, motor overload, Low air pressure
    6. Quality of carton after closing flap for proper closing, embossing / printing, number of blisters, insertion of leaflet should be checked at Initial, End.
    7. Check for functioning of rejection system.

 

 

 

       For  Pharmacode system:

 

  1. Password verification for editing product : Enter incorrect password for editing the set product parameters. Record the observation in the validation Report.
  2. Access code verification for Adjustment Menu : Enter incorrect access code to enter into adjustment menu. Record the observation in the validation Report.
  3. Access code verification to advanced configuration option: Enter incorrect access code to enter into configuration option. Record the observation in the validation Report.
  4. Prepare a leaflet by adding a bar code to the front side. Ensure that the addition of bar code is applied with a black pen, complies with the dimensions and position specified in the Pharma code guide. This particular leaflet should be clearly marked as unusable. Record the observation in the validation Report at equal five intervals. (if machine will run NMT One hour perform at Initial & End).
  5. Add an additional bar code to the code on the carton flap. Ensure that the addition bar code is applied using a black pen, correspond with the dimensions and position specified in the Pharma code guide. This particular carton should be clearly marked as unusable. Record the observation in the validation Report at equal five intervals. (if machine will run NMT One hour perform at Initial , End).

 

  • Ink Jet Printer / Condot Printer:
    1. Put ON the Ink jet print and enter the incorrect password. Ink Jet printer should not accept the incorrect password.

 

  1. Enter the correct password.
  • Operate the Ink Jet Printer as per SOP.
  1. Enter the product detail to be overprinted in the Ink Jet Printer / Condot printer.
  2. Print the product detail on a carton.
  3. Collect the printed carton and check for legibility and ensure that the printed details should match with BPR entries. Record the observation in the report.

 

  • Repeat the steps (vi) at Initial & every 1 hour. (if Machine will run NMT One hour perform at Initial and End).

 

Note: (if stereo printing carried out on carton then only check the overprinted matter with required printing matter as per specification)

 

 

 

 

 

  1. Check Weigher System.
    1. Operate the Check Weigher System as per SOP

 

  1. Set the target weight, with upper and lower weight limit as per SOP.

 

  • Select 5 filled Cartons from the Packing line and pass 5 filled Cartons through the Check Weigher System and record the observations in the validation report.

 

  1. Remove Enclosure from the filled cartons (Five Cartons) and pass the Cartons through the Check Weigher System and record the observations in the validation report.

 

  1. Place additional enclosure in the filled Cartons (five Cartons) and pass the Cartons through the Check Weigher System and record the observations in the validation report.

 

  1. Repeat the steps (iii),(iv) & (v) at Initial & every 30 minutes. (if Machine will run NMT One hour perform at Initial & End).

 

  1. Shrink Wrap Machine: (if applicable)
    1. Check sealing, wrapping, shrinking quality for three pack after sealing at Initial & every 1 hour. (if Machine will run NMT One hour perform at Initial & End).

 

  1. Towards the end of batch set:

 

  1. Set the heaters in shrinking tunnel at temperature about lower temp. and pass one carton pack with shrink through shrink wrap tunnel.

 

  1. Set the heaters in shrinking tunnel at temperature about upper temp. and pass one carton pack with shrink through shrink wrap tunnel.

 

  1. Set the heaters in shrinking tunnel at optimum temperature and pass one carton pack with shrink through shrink wrap tunnel.

 

Check  sealing,  wrapping, shrinking quality  for  three  pack  for  point no. a, b, c.

 

Note: This test applicable only when final product required shrink packing.

 

        VI.          Shipper Weighing Balance:

 

  1. Set the balance for standard number of packs as per SOP.

 

  1. Take 2 shippers filled with the standard number of cartons in it.
  2. Keep one filled shipper on the balance.
  3. Remove one carton from the shipper.
  4. Record the count and the status of alarm (i.e. actuated or not actuated) in the report
  5. Put back the carton which was removed from the shipper and place the shipper on the balance.
  6. Record the count and the status of alarm (i.e. actuated or not actuated) in the report.
  7. Place one more carton along with shipper on the balance.
  8. Record the count and the status of alarm (i.e. actuated or not actuated) in the report
  9. Repeat the step no. ( c ) to ( g ) for the next shipper at Initial & every 1 hour

(if Machine will run NMT One hour perform at Initial & End).

 

               

 

  1. Acceptance criteria:

 

  1. Blister Pack Machine:

 

  1. Leak test observed should be NIL.
  2. Temperature of film Heater for

For EPI 2500:

  1. Temperature of film heater for PVC film should be between 140 – 170 0C
  2. Temperature of film heater for PVC / PVDC or PVC / PE / PVDC film should be  between 150 – 160 0

 

  1. Temperature or Sealing Roller 170 – 210 0C

 

 

  1. Cartonator
    1. Only set size blister should be released in the blister cell.
    2. Carton and leaflet should not be released by the respective sensors,
  • No Blister:
  1. Carton sensor should not release the carton.
  2. No. Carton:
  3. Pusher should not come out.
  1. Removal of carton after closing of flap.

Cartons flap (front and rear) should get closed properly.

 

  1. Ensure that Inter Locks are available for Emergency off, Guards open, Hand wheel, Loading safety, Motor overload, No carton, No leaflet, & Low air pressure, pusher overload.

 

  • Quality of carton should comply as per product specification after closing of flap for Embossing, Printing, Insertion of Leaflet (if any).

 

  • System Should not Accept Incorrect Password.

 

 

  • Ink Jet Printer / Condot Printer

 

  1. System Should not accept Incorrect Password.
  2. The overprinted details on carton should match with that of BPR entries.

 

 

 

 

  1. Check Weigher System:

 

Carton with target should pass through the Check Weigher System and under and over weight cartons should be rejected along with the LED indicator by the Check Weigher System.

 

  1. Shrink Wrap Machine (if applicable)

 

Sealing, wrapping, shrinking quality after sealing must be having food quality & acceptable.

 

  1. Shipper Weighing Balance

 

The alarm should be actuated whenever count is less or more than the standard fill value of the shipper.

 

  1. Non Compliance:

 

Details of deviations or OOS if any should be mentioned in Validation Report.

 

  1. Type of Validation:

 

Concurrent Validation:

 

  1. Frequency:

 

  1. Concurrent validation: Three successful validation exercises.
  2. Re-validation (After major change)

 

  1. Results:

­

Record the observation during the Validation and result obtained in validation report.

 

  1. Summary of finding of validation (inference):

 

Summarize the findings of the validation to draw an inference.

 

 

  1. Recommendation:

 

Record the recommendations based on the interpretation of the results of the validation report.

 

 

 

 

  1. Team Approval:

 

The individuals who have performed the validation, supervised the validation, complete the records, performed the testing of the product should approve the validation report.

 

  1. Review: (Inclusive of follow up action, if any)

 

The validation report should be reviewed by Plant Quality Assurance and Plant Head. The report should include any follow up action if required.

 

 

  1. Approved by:

Plant Quality Assurance and PlantHead should finally approve validation Report.

 

 

  1. Annexures :

 

Annexures (if any) should be attached to the validation report.

 

 

  1. Abbreviations:

 

PVC          : Polyvinyl Chloride

PVDC        : Polyvinyl  Dichloride

PE             : Polyethylene

0C              : Degree Celsius

SOP           : Standard Operating Procedure

QA             : Quality Assurance

No.             : Number

NLT            : Not Less Than

PSI             : Per Square Inch

LED            : Light Emitting Device

Mins.          : Minutes

Kg./Sq.cm  : Kilogram per Square Centimeter

 

 

 

 

 

 

 

 

 

 

Diagrammatical Representation

 

 

Remove One Tablet from any one of the pocket

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Insert Half tablet in any one of the pocket of opposite track

 

 

 

 

 

 

 

 

 

 

 

 

You may also like...

Leave a Reply

Your email address will not be published. Required fields are marked *