To lay down a Standard operating procedure for Rubber Bung Washing Machine.
This procedure provides a standard method to operate the Rubber Bung Washing Machine.
•Head - Production.
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.