Bacterial Endotoxin test for rubber stoppers

Microbiology
1

What is the method for BET of rubber stopper . what is the process of validation and how can we established the limit of BET?

2

By Gel clot method you can perform Stopper BET with limit of 0.25EU/mL.

Take 10 stopper+ Add 100mL Water for BET + Sonicate for NLT 30minutes + Vortex fro NLT 1min+ Take 0.1mL sample+ 0.1 mL Lysate incubate 37±1°C for 60±2 min.
Kept +ve and - ve control as usual.

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3

Please what is the method for conversion of the specifications from EU/ml to Eu/ Stoppers?

I need this information please help

4

is there any Guidelines on packaging for pharmaceutical
products…?