Our lab has just recently purchased a Oven that will be validated/qualified for use in depyrogenating of glassware. I am welcome ideas/thoughts/advice.
Thanks so much!
Kly
Hi, since you have already purchased the oven, I assume a process risk assessment and URS are already in place. Also assuming that you also purchased the IOQ protocol from the vendor, you must assess this protocol and assure all items from your RA/URS are covered. If not, additional testing is in order. Prepare a cover protocol (your own internal protocol) for qualification items regarding documentation (including review of vendor IOQ protocol), training, software validation, planning of maintenance etc. If necessary, add the aforementioned additional tests.
Since this is a dry heat oven, refer to Ph.Eur. 5.1.1 or ‘EMA Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container’ or US equivalent.
Main focus: design depyrogenation process (if applicable, could already be programmed in oven software). Establish loads to be depyrogenized, then establish worst case load(s) and worst case locations based on IOQ data. Inoculate items from worst case load with endotoxins (10^4-10^5 IE/location) and perform depyrogenation process with inoculated worst case load. Perform endotoxin testing of all inoculated items. According to guideline, endotoxin reduction must be >3log10. If so, repeat twice. If not, redesign process and repeat testing. Finally, report findings and have management and QA release the equipment for use.
Hi Claudia,
Thank you so much for your inputs. I totally agree with you response. The equipment has been purchased, the RA/URS is complete.
We performed thermal mapping of various locations of the chamber and also spiked each of the selected locations with endotoxin as worse case and the results for all locations showed endotoxin reduction of greater than 3log10, which all the spiked locations met the requirements.
Your response is very good. I like it. Thanks again for your inputs.
Kly