Mr Rakesh Kumar Sinha, VP & Head-Drug Product Manufacturing, Biological E

Speaker in this video:
Mr Rakesh Kumar Sinha, VP & Head-Drug Product Manufacturing, Biological E

Topic: Contamination control strategy

Key Highlights:
[1] Contamination control prevents three key threats – microorganisms, particles, and pyrogens

[2] It needs a holistic approach where six areas, facilities, equipment, utilities, maintenance, process design, and product/container systems, to work together, as contamination control is only as strong as its weakest link

[3] The stopper hopper is vital for contamination control as it maintains the sterility of closures, minimises human intervention, and ensures consistent, clean handling of components, safeguarding product integrity and patient safety