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Key Takeaways:
- Microbial control is vital in sterile and nonsterile pharma to ensure patient safety and product quality.
- Poor microbial control can cause recalls, regulatory actions and costly remediation.
- 80% of recalls (2004–2011) involved sterile products; 20% due to microbial contamination.
- Robust contamination control strategies should prioritize process design and environmental measures.
- Poor microbial control can cost 20–30% of total sales, proving contamination prevention’s value.
The pharmaceutical industry is facing pressure to continuously challenge and improve its manufacturing processes to achieve regulatory compliance and produce high quality product. New technologies to improve microbial control, support root cause investigation and provide faster response are expected to become available over the next few years.
Read more from our STERIS expert, Walid El Azab along with Edward Tidsell, PhD, Merck who co-wrote an interesting article on the cost of mircobial control.
