Discussion on Blow-Fill-Seal Technology

Environmental monitoring (EM) is critical for Blow-Fill-Seal (BFS) technology, a widely used aseptic manufacturing process for packaging sterile liquids such as pharmaceuticals and medical products. BFS technology involves forming, filling, and sealing containers in a continuous, automated process, which minimizes human intervention and the risk of contamination. However, even in such closed systems, environmental monitoring is essential to ensure the sterility and overall quality of the final product.
Here are some key discussion on environmental monitoring problems specific to Blow-Fill-Seal technology.
Discussion Lead By : Nitin Ahirrao , Senior Manager , Global Corporate Audits ( / nitin-ahirrao-14a89925 )
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
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Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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