Tuesday, July 14, 2009


1. Objective:

To lay down a standard operating procedure for Automatic injectable powder vial filling & rubber stoppering Machine.

2. Scope:

This procedure provides a standard method of operation and handling of the Automatic injectable powder vial filling & Rubber stoppering Machine.

3. Responsibility:

§ Machine operator.

§ Senior Chemist.

§ Head - Production.

4. Procedure:

4.1. Check and make sure that Automatic Injectable Powder Vial and Rubber stoppering machine has been cleaned as per SOP No:P/P/011

4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/050

4.3. Make sure that the filling area has been cleaned properly.

4.4. Switch on the Laminar flow and make sure that it has been wiped with 70% IPA.

4.5. Receive the incoming sterilized, siliconised and dried containers on the unscrambler and suitably guided on to the moving woven conveyor belt at the required speed for the correct placement below the powder wheel.

4.6. Put the sterile powder in powder hopper, which will agitate powder by a pair of mechanical agitators for maintaining consistency and uniform bulk density.

4.7. The precise fill volume of powder is sucked into the port of the powder wheel by means of vacuum.

4.8. The excess powder is doctored off by a blade when powder wheel indexes further and remains in the port due to the vacuum till it reaches just vertically above the container.

4.9. The time dose of Nitrogen sequentially flushes out powder from the port of powder wheel into container one by one.

4.10. The filled containers are immediately separated on the conveyor by container separator and moves further for the stoppering operation.

4.11. Put sterilized, siliconised Rubber stoppers in the Rubber stopper hopper.

4.12. Rubber stoppers are made to pass through mechanical orientation system and stacked vertically in the rubber stopper chute from Rubber stopper hopper.

4.13. The moving container is held firmly between two cogged neoprene belts for correct pick up of rubber stopper from the outlet of Chute.

4.14. Further the container is passed beneath two pressing rollers for tight sealing of rubber stopper.

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