Case Study

A Comparison Of Microbial Environmental Limits

Source: Parenteral Drug Association (PDA)

By Raphael Bar, BR Consulting

A Case Study of Existing Regulatory Action Limits versus USP Recommended Recovery Limits

The new paradigm of microbial monitoring of aseptic processing environments, suggested in USP <1116> (1), continues to raise interest. Yet questions persist regarding its implementation and usefulness compared to existing regulatory limits (2).

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Parenteral Drug Association (PDA)