“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate. Can you put the lid of the plate down when you change the plate. What do you do with the two lids when changing the plate as I thought you could not put them down.
“Hi all, I need your support to find the answers of the following questions:
1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents / studies/ gown).
2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?
Thanks in advance…“
“I have a question on microbiological testing of finished goods. We normally do TCP and Yest and Mold, however some customers are saying that pathogenic bacteria test is required after an enrichment is done. Is this really necessary if the PET passes and the TCP and Yest and Mold are less than 10 cfu?”
“May I know what are the gmp guidelines for manufacturing of hand sanitizers? Does it require cleanroom facility? What is the minimum acceptable requirements for are to be accepted as per gmp guidelines if present?“
Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems. By night he works on his science chops. He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading →