Q. We are moving from LD50 data to ADE (PDE) limits based on HBELs. This is allowing us to eliminate disposables for low-risk products. How do I know which can be manually cleaned and which needs to be in a washer? Can manual cleaning be validated? A. Many pharma and biotech companies have been moving to Health-Based Exposure Limits (HBELs) meaning Acceptable Daily Exposure … [Read more...] about Risk Based Limits and Pharmaceutical Cleaning
inhibitory residue test
Q. Our pharmaceutical company is transferring product manufacture to a different one of our facilities. We used a CIP cleaning process with Citrajet detergent and are going to have to perform validation and verification tests again. What information do we need for our testing? Chemical properties might be helpful as well as the science on how this chemical works. We would also … [Read more...] about Clean in place (CIP) with Citrajet Detergent
Q. What is an inhibitory residue test? A. The inhibitory residue test (IRT) is a test of suitability of glassware for microbiology testing. The test is described in Standard Methods SM 9020B3a (Editions 18, 19) or SM 9020B4a (Editions 20, 21). It is similarly described by the US Environmental Protection Agency in SOP Number: QC-03-07 and EPA’s “Manual for the Certification … [Read more...] about What is an Inhibitory Residue Test?