We have a bung processor cum steam sterilizer. We are using this equipment for bung washing, siliconisation, drying and sterilisation by moiast heat.During routine practice, after each cycle of bung processing we are sending drain water of last rinse cycle for PH test and after sterilisation we are doing LOD test for bungs. But during re-qualification we are only validating sterilisation cycle for bung load and we are doing nothing to validate for bung washing and drying .
My querry is whether we require any other tests for validating bung washing cycle though we are routinely test for drain water PH and LOD?
Expecting reply please.
With thanks and regards
Have you not tested that for Particulates & Endotoxins during validation cycle?
We have tested for endotoxins during validation but not tested for particulates
Chemical tests of aquaeous autoclavates:
-heavy metals (e.g. zinc)
-Discolouration of stoppers
-Particle and fibre shredding etc…[/color]
[COLOR="#0000CD"]-penetrability with a needle
-Fragmentation of the rubber after piercing
-self-sealing after removing the needle[/color]
Can you please explain the procedure for endotoxin challenge test during qualification of Bung processor.
Spike your Bungs with a specified and detectable amount of endotoxin on to a batch that is a representative of the bung batch size normally you consider during your production process.
Now you must run all your cycle and control normally as per schedule and process.
Examine the Endotoxin contents in the WFI used and also on the bungs prior to wash and also in the steam that is entering your autoclave. Make sure that you use a Pure steam. When you have autoclaves with Black steam or directly connected to boilers they will pose problems and you have to identify those in such casses.
Black steam is discouraged by regulatory authorities in Pharma plants these days.
After evaluation all considerations you must start you operations.
Collect the water from the Bung washer outlet during washing cycles and also determine for Endotoxins.
After all washing is completed and when rubber stoppers are unloaded , collect the required number of rubber stoppers from sterile area with a proper technique using Sterile-Endotoxin materials in a proper sterile-Endotoxin free container for next evaluation stages.
You should prove atleast 3 log reduction of endotoxins during this evaluation.