RUBBER BUNG WASHING MACHINE

1.OBJECTIVE:
To lay down a Standard operating procedure for Rubber Bung Washing Machine.
2.SCOPE:
This procedure provides a standard method to operate the Rubber Bung Washing Machine.
3.RESPONSIBILITY:
•Machine Operator.
•Senior Chemist.
•Head - Production.

4.PROCEDURE:
4.1.Check and ensure that the Rubber Bung washing machine is free from dust & it is cleaned as per SOP No:P/P/015.
4.2.Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/053
4.3.Fill the vessel with solution of 0.1% Tween 80 and DM water.
4.4.Transfer the Rubber Bungs to be washed into the vessel. Supply the steam into it at 116°C/10 lbs for 35 mins.
4.5.After 35 mins cut the steam supply & give compressed air to remove the foam which is formed because of the Tween 80 solution. Drain the washed water.
4.6.Add sufficient quantities of DM water which is filtered through 5µ filter. Apply the filtered steam and compressed air at a pressure of 4 Kgs/cm2 for half an hour.
4.7.Drain the water through the suitable valve and check for the clarity.
4.8.Repeat the step 4.5 & 4.6 until to get the clarity.
4.9.For liquid Injectable, add specified preservatives solution of specified concentration in the rubber bungs to avoid the chemical reaction with products to be sealed.
4.10.For powder injectable, add silicone oil emulsion at a concentration of 0.1% in the rubber bungs instead of preservatives.
4.11.Distribute the rubber bungs into SS Rubber Bung box. Drain the water by lifting down the SS hole Rubber Bung box.
4.12.Sterilize it at 116°/10 lbs for 35 mins in steam heat sterilizer.
4.13.Finally put all washed Rubber Bungs in the Dry heat sterilizer for drying.

AUTOMATIC AMPOULE FILLING & SEALING MACHINE (4 STROKE)

1.OBJECTIVE:
To lay down a standard operating procedure for Automatic Ampoule Filling & Sealing Machine
2.SCOPE:
This procedure provides a standard method to operate and handle 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, it 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 with the help of 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.Again 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 Ampoule 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 through the collection hopper and finally to the crates with proper labeling.