Blister Pack line Validation Report for ALU/ALU Pack

 

Blister Pack line Validation Report for ALU/ALU Pack

 

1. Objective:

      To validate the packing process of _____________________________________________ B. No. ______________________________ Batch size _________________ & pack size                _________________________________ on the Blister Pack line.

 

1. Scope:

Applicable to Blister Packing of tablets.

 

3. Justification:

___________________________________________________________

 

4. Site of study:

Packaging Department

 

5. Responsibility:

Production              : ___________

Quality Assurance  : ___________

Engineering            : ___________

(Individuals name to be recorded in report)

 

1. Description of equipment to be used:

      BLISTER PACK MACHINE

Code No. : ______________

Equipment Qualification done on _______________

 

CARTONATOR

Code No. : ______________

Equipment Qualification done on  _______________

 

CONDOT PRINTER / INK JET PRINTER

Code No. : ______________

Equipment Qualification done  on _______________

 

 

Reviewed by Sign and Date : _______________

CHECK WEIGHER

Code No. : ______________

Equipment Qualification done on _______________

 

SHRINK WRAPPING MACHINE (if applicable)

Code No. : ______________

Equipment Qualification done on _______________

 

SHIPPER WEIGHING BALANCE

Code No. : _______________

 

Equipment Qualification done on _______________

 

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

Packing of the product done as per Packing procedure :

1. Standard Operating Procedures (SOP) for operating Operation of the Blister pack machine.

SOP No. : __________

 

1. Standard Operating Procedures (SOP) for operating Cartonator :

SOP No. : __________

 

• Standard Operating Procedures (SOP) for operating Condot Printer / Ink Jet

Printer.

SOP No. : __________

 

1. Standard Operating Procedures (SOP) for Check Weigher :

SOP No. : __________

 

1. Standard Operating Procedures (SOP) for Shrink Wrapping Machine

(If applicable):

SOP No. : __________

 

1. Standard Operating Procedures (SOP) for Shipper Weighing balance:

SOP No. : __________

 

 

Reviewed by Sign and Date : _______________

8. Batch packing record (BPR) to be followed:
9. Record Pack code as per BPR

Pack code : ______________

 

10. Controls: Requirements :
    1. Blister Pack Machine:
11. Blister Pack machine speed.

Machine speed : _______________      Limit : _______________

1. Temperature Range of platen Heater : _______________.
2. Calibration :

Calibrated compressed air Pressure gauge. Code No. _______________

Calibration pf pressure gauge done on : ______________

Calibration of pressure gauge due on : _______________

 

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

 

• Condot Printer:

1. The printer must be adapted to production line.
2. The printer must be initialized.
3. Sensor for sensing the carton should be kept “ON”.

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

 

1. Check Weigher System :
   1. Sufficient compressed air pressure should be kept at carton blow station. (NLT4 bar)
   2. Conveyor speed.
   3. During validation ensure that container/pack with improper count/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 (If applicable):

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:

Equipment	Code No.	Calibration done	Calibration due

 

 

Reviewed by Sign and Date : _______________

 

 

1. Training :

 

Training details of personnel involved in validation.

Name	Training status	Training report availability	Checked by

 

1. Precautions :

 

Safety aspects while operation of equipments and process must be ensured.

 

1. Validation Procedure:

                                             Packing Process Flow Diagram :

 

Blister packing

 

 

 

 

Cartonator

Cartons                                   Cartonating

 

 

 

Condot/Ink jet printer

 

Carton Overprinting

 

 

 

 

Check Weigher

Weighing of Carton

 

 

 

 

Shrink Wrapping Machine

Shrink Wrapping (As Applicable)

 

 

 

 

Outer carton

 

 

 

 

Shipper Packing

 

Reviewed by Sign and Date : _______________

 

Carry out as per Validation Protocol No. PU07/BPV/VP/02   Ver.No. 01

Department :
Product :
Batch No :
Date of Validation :

 

Equipment :	Blister Pack machine
Code No:
Make :.

 

Equipment :	Cartonator
Code No:
Make :.

 

Equipment :	Condot Printer/Ink jet Printer
Code No:
Make :.

 

Equipment :	Check Weigher System
Code No:
Make :.

 

Equipment :	Shrink Wrapping Machine (As applicable)
Code No:
Make :.

 

Equipment :	Shipper weighing Balance
Code No:
Make :.

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

12. Acceptance criteria:
    1. Blister Pack Machine:
    2. Leak test observed should be NIL.
    3. Pocket formation on web should be uniform without any breakage.
    4. Temperature of flat platen film Heater should be 155±10⁰C
    5. There should be no pin holes on blister.
    6. Knurling should be uniform.
    7. The non filled packs should be sensed and rejected on line on the machine and filled packs must not be rejected by the NFD system.

 

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.
3. No Blister :
   1. Carton sensor should not release the carton.
      1. No Carton :
         1. Pusher should not come out.
            1. Removal of carton after closing of flap Cartons flap (front and rear) should get closed properly.
            2. Ensure that Inter Locks are available for Emergency off, Guards open, Hand wheel, Loading safety, Motor overload, No carton, No Product No leaflet & Low air pressure.
            3. Quality of carton should comply as per product specification after closing of flap for Embossing, Printing, Insertion of Leaflet (if any).
            4. System Should not Accept Incorrect Password.
            5. Marked Label, Leaflet and Carton should Recognized as “ERROR” and machine must stopped.

 

• Condot Printer/Ink jet Printer:

1. System should not accept incorrect password.
2. The overprinted details on carton should match with that of master entries.

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

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.

 

13. Non Compliance:

 

1. Details of Deviations :

Deviation Report dated	Checked by

1. Details of OOS:

OOS  Report dated	Checked by

 

14. Type of Validation:

Concurrent Validation:

 

15. Frequency:

Concurrent Validation: Three successful validation exercises.

Re-validation (After major change.)

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

16. Results:
    1. Blister Pack machine :

Date/ Time	Temperature of film platen heater Range :___ to ___	Leak Test NIL	Checked by

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

 

Date/ Time	Pin holes	Knurling Uniformity	Checked by

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

• Non-Filled Detection System:
  1. Remove One Tablet

Date	Time	Audio alarm for sensing missing tablets Yes/No	Non filled pack Rejected / Passed	Filled pack Rejected / Passed	Checked by

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

1. Insert Half Tablet

 

Date	Time	Audio alarm for sensing missing tablets Yes/No	Non filled pack Rejected / Passed	Filled pack Rejected / Passed	Checked by

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

1. Empty blister

 

Date/ Time	Audio alarm for sensing missing tablets Yes/No	Non filled pack Rejected / Passed	Filled pack Rejected / Passed	Checked by

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

1. Observation at lower speed.

Condition	Date	Time	Temperature of film platen heater ___ to ___	Knurling Uniformity	Pin holes	Leak test	Checked by
Lower Temp.
Higher Temp.

 

 

 

 

1. Observation at Higher speed.

Condition	Date	Time	Temperature of film platen heater ___ to ___	Knurling Uniformity	Pin holes	Leak test	Checked by
Lower Temp.
Higher Temp.

 

1. Observation at Optimum speed.

Condition	Date	Time	Temperature of film platen heater ___ to ___	Knurling Uniformity	Pin holes	Leak test	Checked by
Lower Temp.
Higher Temp.

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

1. Cartonator

Date	Time	Tests	Acceptance Criteria	Observation
		Set size of blister to be released from the blister cell.	Only Set size of blister should be released in the blister cell.
		No blister inn the blister cell	Cartons and leaflet should not be released.
		Leaflet below sensor level in the leaflet magazine box.	Machine should stop with proper justification on monitor.
		Carton below sensor level on the packing line.	Machine should stop with proper justification on monitor.

 

 

Date/ Time	Tests	Acceptance Criteria	Observation
—	—	—	1	2	3	4	5
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

Date/ Time	Tests	Acceptance Criteria	Observation
—	—	—	1	2	3	4	5
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.

 

 

 

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

Date/ Time	Tests	Acceptance Criteria	Observation
—	—	—	1	2	3	4	5
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.
	Remove the carton after closing of flap, Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure.	i. Cartons flap (front and rear) should get closed properly.
		ii. Cartons flap should get properly embossed or printed. (if applicable)
		iii. filled blister and enclosure should be present in the carton printing should done properly.

 

 

 

 

 

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

Check the interlocking of following:

 

Tests	Acceptance Criteria	Observation
Emergency off	Interlock should be available for these.
Guards open	Interlock should be available for these.
Hand wheel	Interlock should be available for these.
Pusher Overload	Interlock should be available for these.
Motor overload	Interlock should be available for these.
No carton	Interlock should be available for these.
No leaflet	Interlock should be available for these.
Quantity of carton after closing flap for proper closing. Embossing / printing, number of blisters, insertion of leaflet	Pack should comply with the standard pack specification	Initial	End

 

Pharmacode system :

 

Date / Time	Checks	Acceptance Criteria	Observation
	Password verification for editing product: Enter incorrect password for editing the set product parameters.	System should not accept the incorrect password.
	Access code verification for Adjustment Menu: Enter incorrect access code to enter into adjustment menu.	System should not accept the incorrect password
	Access code verification to advanced configuration option: Enter incorrect access code to enter into configuration option.	System should not accept the incorrect password

 

 

Reviewed by Sign and Date : _______________

 

 

Date / Time	Checks	Acceptance Criteria	Observation
	Password verification for editing product: Enter incorrect password for editing the set product parameters.	System should not accept the incorrect password.
	Access code verification for Adjustment Menu: Enter incorrect access code to enter into adjustment menu.	System should not accept the incorrect password
	Access code verification to advanced configuration option: Enter incorrect access code to enter into configuration option.	System should not accept the incorrect password
	Password verification for editing product: Enter incorrect password for editing the set product parameters.	System should not accept the incorrect password.
	Access code verification for Adjustment Menu: Enter incorrect access code to enter into adjustment menu.	System should not accept the incorrect password
	Access code verification to advanced configuration option: Enter incorrect access code to enter into configuration option.	System should not accept the incorrect password
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.
	Prepare a leaflet by adding a bar code to the code on the front side.	Cartonator must stop.

 

 

Reviewed by Sign and Date : _______________

 

	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.
	Add an additional bar code to the code on the carton flap.	Cartonator must stop.

 

1. Ink Jet Printer:
2. Product details fed in the Ink Jet/condot Printer/stereo printing.

 

Carton _________________________

_________________________

_________________________

_________________________

 

 

 

 

Reviewed by Sign and Date : _______________

Date / Time	Overprinting Details Observation On

 

 

 

Reviewed by Sign and Date : _______________

D.Check Weigher System:

 

Date / Time	Count shown	LED indicator	Observations					Checked by
			1	2	3	4	5
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

Date / Time	Count shown	LED indicator	Observations					Checked by
			1	2	3	4	5
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

Date / Time	Count shown	LED indicator	Observations					Checked by
			1	2	3	4	5
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

Date / Time	Count shown	LED indicator	Observations					Checked by
			1	2	3	4	5
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more enclosure	Y
	Carton with out enclosure.	R
	Carton with standard fill value (as per specification)	G
	Carton with one more Blister.	Y
	Carton with out Blister.	R
	Carton with standard fill value (as per specification)	G

 

Note : 1) Y & R – Rejected    2) G – Passed

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

 

1. Shrink Wrap Machine (If applicable):

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking

 

 

Reviewed by Sign and Date : _______________

 

 

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking
	Sealing
	Wrapping
	Shrinking

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

1. Set the temperature – Lower temperature ___________ ⁰C.

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking

 

1. Set the temperature – Higher temperature __________ ⁰C.

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking

 

1. Set the temperature – at optimum temperature ___________ ⁰C.

 

Date / Time	Test	Observation			Checked by
	Sealing
	Wrapping
	Shrinking

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

1. Shipper Weighing balance:

 

Date / Time	Count shown	Observation Alarm		Checked by
		Actuated	Not Actuated
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

Date / Time	Count shown	Observation Alarm		Checked by
		Actuated	Not Actuated
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)
	Shipper with one carton more.
	Shipper with one carton less.
	Shipper with standard fill value (as per specification)

 

 

 

 

 

 

 

 

Reviewed by Sign and Date : _______________

 

 

 

 

17. Summary of finding of validation (inference):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18. Recommendation:

 

 

 

 

 

 

 

 

19. Team Approval:

 

 

 

_____________          _______________            _____________

Production                 Quality Assurance               Engineering

 

Date:

 

 

 

 

Reviewed by Sign and Date : _______________

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

 

 

 

 

 

 

 

 

21. Approved by:

 

 

 

 

____________________                                    ____________

Quality Assurance                                       Plant Head

 

Date:

 

22. Annexures :

 

 

23. Abbreviations:

 

NFD          : Non Filled Detection

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

 

Reviewed by Sign and Date : _______________