SOP for Cleaning Procedure of Capsule Polishing Machine

OBJECTIVE

To lay down a procedure for cleaning of capsule polishing machine.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of PharmaInfo Limited. This procedure covers cleaning of capsule polishing machine.

RESPONSIBILITY

The concerned operator is responsible for the implementation of the process.

The Production In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

Type “B” Cleaning Procedure (Product to Product Change Over).

• De-dust the external surface using a clean nylon brush.
• Remove the powder from the powder collection traps and sieves of the hopper and clean them with liquid soap, wash off the liquid soap with potable water, then finally rinse with filtered purified water and dry with a lint-free cloth.

• Remove the hopper assembly and the guards and clean as above.
• Remove the vacuum filter bag from the vacuum can and use a new filter bag.
• Remove the capsule transfer chute, and the upper and lower halves polishing chamber, remove the acrylic conveyor belt, de-dust all parts, and wash as in step 2.
• Remove the polishing brushes and polishing cloth. De-dust them as in step 1 clean as in step 2 and dry them.
• Once all the parts are cleaned and dry, assemble back the machine.

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Type “A” Cleaning Procedure (Batch-to-Batch Change Over).

• Remove all the powder from the powder collection trays.
• De-dust all external surfaces using a nylon brush and vacuum cleaner.

• De-dust the brushes; de-dust the acrylic conveyor belt by holding the vacuum suction end of the vacuum cleaner, while running the machine empty.
• Similarly de-dust the polishing cloth. Cover the whole machine with polythene sheets.
• All the cleaning details shall be entered in the equipment cleaning log.

REFERENCE

SOP: Preparation, Approval and Control of Standard Cleaning Procedures for equipment.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil

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