White Paper — Sponsored Content

Microbial Contamination Risks & Preventing Them with Real-Time Analysis

 Microbial Contamination Risks & Preventing Them with Real-Time Analysis

Microbial contamination is the biggest risk that faces the pharmaceutical industry today in terms of making products that meet safety, quality, and efficacy requirements. A couple of the many risks associated with microbial contamination in pharmaceutical waters include the possibility of having to scrap a production batch and even worse – product recalls. Pharmaceutical waters must be monitored closely for contaminants and testing for microbial contamination can be done by sampling and plate counting, but this method is culture based, is time consuming, and also prone to errors. Regulatory committees are emphasizing on-line measurements for "real time process control, decisions and interventions" (PAT [Process Analytical Technologies] initiative by the FDA). New technology offering continuous monitoring of bioburden in pharmaceutical water systems is available and can be used in parallel with plate counting to ensure process control with no waiting period. This white paper details the problems associated with pharmaceutical water contamination and summarizes the potential impacts of contaminated water and provides insights on how to mitigate risks.

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