SHAIGAN

Standard Operating Procedure for

cleaning of vial filling machine SOP #. PR\SP- 009
Prepared By: Production Pharmacist Effective Date: 01- 08- 03

Approved By: Production Manager Rev.#:00

Rev Date:

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Reference: SPL

PURPOSE

Purpose of the procedure is to clean the vial filling machine.

PROCEDURE

 Once the batch is completed switch off the main electric supply of the
machine
 Dismantle filling nozzle ,silicon pipes and other accessories including star
wheel from the machine
 Remove glass particle from the corners, gaps and conveyer belt by using
nylon brush.
 Clean the exterior surface of the machine, turntable and conveyer belt by
using pyrogen free water (2 liters) until no spots of solution remains there.
 wash filling nozzles ,silicon pipes and star wheel with 0.1% teepol solution
 filling nozzles and silicon pipes are further autoclaved as per filling
procedure ,while star wheels are sprayed with 70% IPA before entering to
sterile area
 finally wipe the whole surface of machine with 70% IPA
 wipe the exterior of laminar flow hood with 70% IPA

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