Dear All,
Is there any one who know & can guide me regarding endotoxin spiking to rubber stoppers and check it’s reduction during autoclave validation.
Kishor D.Patawar
To asses complete washing ability of a bung processor you can add a required amount of ink to the stoppers. During the washing cycle inside the bung processor all the ink will be washed off. You must use a suitable ink during validation
For endotoxin validation you must spike a required detectable quantity of Endotoxin to the rubber bung and spike that. You must carry the washing and sterilization cycles.
You must atleast have a proved method to reduce between 4 to 6 logs.
This is achievable most during the bung washing and sterilizing cycles.
The limit of bungs inside such washing machines should be properly considered and taken care during both validation and real time component preperation cycles. You must take care to over load rubber bungs.
Dear Sir,
Thanks for reply. Does it mean that, this is the requirement only to those performing bung washing & sterilization ?
If not, is it really required to those using ready for sterilization bungs? Can you provide me any guide line in this regards?
Regards,
Kishor D.Patawar
After each sterilization cycle you need to take sample and validate.
If you use ready for sterilization bungs then you have to still test for Endotoxins after you sterilize.
You have to have documental evidence that your process is right.
There is no short cut.
You can look WHO guidance on this.