SOP for Procedure for De-Foiling of Blisters

OBJECTIVE

To lay down a procedure for de-foiling blisters.

SCOPE

This procedure applies to the packing department in the Pharmaceutical Manufacturing Facilities of PharmaInfo Limited.

RESPONSIBILITY

The packing staff is responsible for the 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 bags 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, and oil stains and put them in a bag labeled “TO BE DESTROYED “.

ALSO READ: SOP for Repacking of Online Recovery after De-foiling of Product

• Put all Recoverable tablets/capsules in a new polythene bag, properly labeled and tied with Cello tape, and keep in an HDPE container. Put the RR’s label on the container.
• Get the number of sorted tablets/capsules checked by the 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 a double polythene bag and tie them with cello tape, in an HDPE container with a proper label containing all details.
• Put all scrap in a poly bag label it and send it for disposal.

REFERENCE

Nil.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

H.D.P.E: High density polyethylene

R.R: Recoverable rejects

ANNEXURE

Nil.

REVISION HISTORY

Nil

ALSO READ: SOP for De-Stripping and De-Blistering