Pharma and Biotech companies are focusing on particulate contamination for three reasons:

• Focus on selling to Japanese markets where requirements are more stringent
• Attention from FDA resulting in product recall
• Move to vision-based inspection resulting in higher rejection rates at the end of fill-lines

Despite having a clean room environment in their manufacturing process, Pharma and Biotech companies are finding particulate contamination difficult to reduce:

• Limited ID work on particles – major risk for sensitive drugs and critical medical devices.
• Sources of contamination and method of cleaning are not well studied.

Pharma and Biotech manufacturing process is focused on biological contamination and not on particulate contamination.

Observations from recent work done by Three S Consulting:

• Pharma industry relies on washing to clean products, equipment, tote boxes, etc.  The effectiveness of the washing process, while useful for eliminating biological contamination, is questionable for reducing particulate contamination
• Plants and manufacturing processes are not well designed to reduce particulate contamination

Pharma / Biotech industry will have to fundamentally think about the manufacturing process and supply chain to address particulate contamination