Packing Validation

Packing validation is performed to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements.

Manufacturing and packaging facility has been qualified to meet cGMP requirements.

Equipment’s / Instruments to be used in packing has been qualified / calibrated.

Machine feasibility studies shall be performed (wherever required) with tentative parameters (based on the experience and the historical data) before running the validation batches. The process parameters confirmed during machine trials and feasibility studies shall be used as process parameters for validation batches.

Machine feasibility studies shall be initiated for new packing design or new pack introduced other than existing packs.

The Packing Validation shall be conducted on minimum three consecutive batches for  each strength of product.

During packing validation below critical variable shall be considered for packing Validation Protocol preparation but not limited.

A. Blister Packing Machine

1) Forming Temperature (Low and High forming temperature).

Why at Low and High forming temperature is required to challenge :

Low Forming Temperature could lead to insufficient depth of pockets & high temperature leads to deformation of the foil.

2) Sealing Temperature (Low and High Sealing temperature).

Why Low and High Sealing temperature Required :

Sealing of the Aluminium foil depends on the Sealing Temperature. Low Sealing Temperature leads to inadequate sealing resulting in failure of leak test. High Sealing Temperature leads to deformation of the film & adverse impact on the product.

3) Speed (Low and High speed)

Why at High and Low Speed Challenge is Required :

Machine speed determines the contact time of the foil during sealing with the sealing Plate & this has an impact on the stability of the product in the final pack. Machine also has an impact on quality of embossing

4) All blister pockets filled.    

5) Leak test.

6) Over-coding / Overprinting.

7) Cutting.

8) Knurling.

9) Print registration control.

10) Splice detector.

11) Function of base and  lidding  foil.

12) At Slow Speed and High Sealing Temperature machine shall be run and sample shall be collected and send to Quality Control for analysis to know the impact of temperature on the quality of the product.

B. Cartonator :

 1) Speed (Low and High speed).

 2) Carton formation.

 3) Challenge test of Pharmacode Carton and Leaflet.

 4) Presence of Blister and Leaflet in Carton.

 5)  Embossing or over coding of batch details on the carton.

 C. Check weigher :

1) Speed (Low and High speed).

2) Under weight and over weight of carton.

D. Bundling Machine and Shrink Wrapping :

1) Temperature (Low and High temperature).

2) Speed (Low and High speed).

E. Bottle Packing Line :

1) Speed (Low and High speed).

2) Leak test                                                                                                           

3) Correct No. of Packing component in Bottles (e.g. silica gel or desiccant, cotton).

4) Torque Value.

5) % Induction Sealing Power

6) Pharmacode Challenge test of Bottle label (As Applicable).

7) Barcode Challenge test of Bottle label (As Applicable).

8) Pharmacode Challenge test of leaflet (As Applicable).

9) Barcode Challenge test of leaflet (As Applicable).

10) Bottle without leaflet.

11) Overcoding of label.

12) Challenge test of Bottle Without label.

F. Dry syrup Packing Line :

1) Speed (Low and High speed)

2) Leak test                                                                                                                  

3) Weight Variation (Net Fill Content  of individual bottle from each head)

4) Torque Value

5) Capping and Sealing Quality of Bottles

6) Bottle without foil

7) Pharmacode Challenge test of Bottle label (As Applicable)

8) Barcode Challenge test of Bottle label (As Applicable)

9) Pharmacode Challenge test of leaflet (As Applicable)

10) Barcode Challenge test of leaflet (As Applicable)

11) Bottle without leaflet

12) Overcoding of label

13) Challenge test of Bottle Without label.

Packing validation shall be performed as per Packing validation protocol

When Packing Validation Shall be Performed:

1) The introduction new packaging equipment.

2) A Change in the packaging Specification.

3) A Change in the Primary Packing Material.

After completion of packing validation activity packing validation report shall be prepared and the results obtained has to be reported in the report.

In the Summary report we have to mention the Low and High limit for Sealing temperature, Forming temperature and speed of machine etc. & based upon the report packing master documents can be revised to include the same.


7 thoughts on “Packing Validation

  1. I would like to know if the size of the batch has an impact when performing the validation. I meant if my validation run has a batch size of 4000 blisters, do I need to package 4000 blisters all the time or is the validation also valid for a smaller batch of 400 blisters for example?


    1. No change in batch size has no impact on packing validation because if your blister machine speed and other parameters like Forming and sealing is validated it has no impact in change in batch size…


  2. If there is increase in HTF foil GSM then is it required to go for packaging validation? Please share reference guide line


    1. To evaluate the impact on Product packing verification to be performed for One batch and the packing inprocess parameters to be verified i.e forming, sealing temperature etc… Everything is not available in Guideline and it depends on the risk based approach..


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