One of the most critical operations in pharmaceutical manufacturing is the processing of sterile products. The production of sterile products, specifically the ones that cannot be terminally sterilized,involve complex and demanding processes to prevent the products’ contamination and require a great amount of resources. The objectives of review includes: Obtain information on operations impacting on […]
Few facts about Dynamic Pass Box Through this blog we will be providing you the qualification and routine maintenance of dynamic pass boxes in your critical and non critical area. As per the industrial practices some time we do more than the requirement and that create an additional burden for us. Rather than doing extra […]
1. What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?A firm’s justification for the frequency of media fills in relation to shifts should be risk […]
