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SOP for Procedure for De Foiling of Blisters

OBJECTIVE
To lay down a procedure for de foiling blisters.

SCOPE
This procedure applies for packing department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY
The packing staff is responsible for implementation of the process.
The Packing In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE
  • Use clean gloves during de foiling of blisters.
  • Cut rejected strips by using scissors without damaging tablets / capsules over polythene bag lined on S.S Trays.
  • Remove tablets / capsules by hand from cut strips/blisters.
  • Sort out good tablets by removing foil pieces and broken tablets / damaged capsules.
  • Collect tablets or capsules with black particles, oil stains and put them in a bag labeled as “TO BE DESTROYED “.
  • Put all Recoverable tablets / capsules in a new polythene bag, properly labeled and tied with Cello tape, and keep in a HDPE container. Put the RR’s label on the container.
  • Get the quantity of sorted tablets/capsules checked by Beta-Lactam in-charge and by Quality Assurance Executive.
  • Pack such de foiled, sorted tablets or capsules at the end of the batch and indicate in B.P.R
  • In case it is not packed in the same order. Keep them in double polythene bag and tie with cello tape, in a HDPE container with proper label containing all details.
  • Put all scrap in a poly bag label it and send it for disposal.

REFERENCE(s)
Nil.

ABBREVIATION(s)
Q.A : Quality Assurance
SOP : Standard Operating Procedure
No. : Number
P.D : Production
H.D.P.E : High density poly ethylene
R.R : Recoverable rejects

ANNEXURE(s)
Nil.

REVISION CARD
Nil

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