Tuesday, July 14, 2009


1. Objective:

To lay down a standard operating procedure for Automatic Ampoule Filling & Sealing Machine

2. Scope:

This procedure provides a standard method of operation and handling of the Automatic Ampoule Filling & Sealing Machine.

3. Responsibility:

§ Machine Operator.

§ Senior Chemist.

§ Head - Production.

4. Procedure:

4.1. Check and make sure that Automatic Ampoule Filling and Sealing Machine has been cleaned as per SOP No: P/P/010

4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No: P/P/044

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

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

4.5. Feed the Ampoules to an inclined charging hopper from Sterilized S.S boxes.

4.6. The Ampoules are passed continuously through rotating feeding wheel, which in turn transfers the Ampoules positively to Ampoule conveyor by the Charging hopper.

4.7. The Ampoule conveyor carries the Ampoules vertically at an angle of 300.

4.8. Pass the nitrogen (Inert Gas) into the empty Ampoules.

4.9. The volume to be filled passes through the pumps, by positive displacement through the non-return valve, filling tubes and filling needles, finally into the Ampoules.

4.10. Pass the nitrogen (Inert Gas) into the Filled Ampoules.

4.11. The filled Ampoules are moved to sealing station.

4.12. In sealing station the Ampoules necks are pre-heated and the pre-heated necks are gripped by the draw-off tongs and sealed.

4.13. Make sure that the sealing has been done before the Inert gas can diffuse to the outside.

4.14. Collect the sealed Ampoules in the collection hopper with proper labelling.

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