SOP for Manual Defoiling of Blisters and Bottles

1.0 PURPOSE:

To lay down the procedure for manual defoiling of blisters and bottles.

2.0 SCOPE:

The SOP for manual defoiling of blisters and bottles is applicable for manual defoiling of blister and bottles at (Company name).

3.0 DEFINITIONS:

Nil.

4.0 RESPONSIBILITY:

4.1 Production/packing operator is responsible to follow the procedure. 
4.2 Production/packing officer/executive is responsible for implementation of the procedure.
4.3 Head-Production/Packing is responsible to ensure compliance of the procedure.

5.0 PROCEDURE:

5.1 Manual defoiling of blister: 
5.1.1 Wear hand gloves and gown as per the gowning procedure.
5.1.2 Ensure that the rejected blisters collection bin is clean and dry.
5.1.3 Place a clean polybag in the collection bin and label it as to be inspected.
5.1.4 Transfer the rejected blisters from secondary to primary blister packing area through rejection bin and start the defoiling activity.
5.1.5 Use surgical blade/scissor for cutting the sealed portion of blisters and defoil the tablets or capsules by manually or use defoiling machine. Collect the defoiled empty blisters in a clean polybag.
5.1.6 Collect the empty rejected blisters in a clean polybag.
5.1.7 After completion of defoiling activity, decontaminate the empty blisters, tablets or capsules and destroy the rejected blisters, tablets or capsules.
5.1.8 Record the activity in the BPR if applicable.
5.2 Manual defoiling of bottles:
5.2.1 Wear hand gloves gown as per the gowning procedure.
5.2.2 Ensure that the rejected bottle collection bin is clean and dry.
5.2.3 Place a clean polybag in the bin and label it as to be inspected.
5.2.4 Transfer the rejected bottles into the bulk filling area and start the defoiling activity.
5.2.5 Use surgical blade/scissor for cutting the sealed portion of bottles, open the bottles, and take out the tablets or capsules.
5.2.6 Collect the same again in a clean polybag.
5.2.7 After completion of the activity decontaminate the empty bottles, closures, cottons and desiccants, tablets/capsules and destroy them as per respective SOP.
5.2.8 Record the activity in the BPR if applicable.

6.0 ABBREVIATIONS:

SOP: Standard Operating Procedure.
BPR: Batch packing record. 

7.0 REFERENCES:

Nil.

8.0 LIST OF ANNEXURES:

Nil.

2 thoughts on “SOP for Manual Defoiling of Blisters and Bottles”

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