Review and monitoring the sterility assurance level

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 sterility, to identify areas for improvement and correction.
• Evaluate current good manufacturing practices in the sterile drug industry.
• Initiate appropriate action against manufacturers observed to be out of compliance.

Clearing the Mystery of Dynamic Pass Box

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 we should adopt some scientific rationale to define the risk level in our facility. Doing correct things in right time gives us the assurance of better compliance. I will suggest don’t think about the compliance all time, we should confirmed our procedure are made based upon robust scientific background.

Now we will be coming to fact. Dynamic pass box nothing but consider as air lock. It is provide a physical barrier in between different between or in between same grade. Normally dynamic pass box installed in the clean rooms as per follow pattern,

Media fill FAQ

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?