We are currently working on studies to assess the residual level of HP adsorbed and released by materials and equipment undergoing a VHP decontamination cycle. We also want to determine the absorption into drug product exposed to the traditional 1ppm HP residual concentration during open phase handlings.
I would really appreciate if you could share experiences/positions on this topic as it can become a hot topic for authorities. Many thanks for your participation.
In fact, in order to prove that H2O2 residue after VHP decontamination cycle does not exceed acceptance level (i.e. in your circumstances - 1ppm) you should have an appropriate analytical method for determining low levels of HP. From point of view of my experience, the best method is Chemoluminescence, that allows to detect diminutive quantities of H2O2. However, for range of quantities 1- 10 ppm it is possible to use method of UV-spectrophotometry. Off course, The Analytical Method have to be validated. In your case i would suggest to use swabbing from internal surface of isolator, and having validated method just prove that residue level does not exceed an acceptance criteria.
Something like this)
P.S. Comments are wellcome.
P.P.S. Sorry for my imperfect English.
Many thanks for your answer.
The method to assess the residual HP on packaging (adsorption) and in drug products (release and absorption) will be an AmplexRed method.
My question was more about the management of the results and the way to ensure product stability and also to know if this matter was managed by other manufacture using isolators.
Thanks.
“Drager tubes” are available in the market, which can determine the H2O2 from 0.1 to 100 ppm. If u google the name, u can find many more details