Whitepaper:
Improving Sterility Assurance within Lower-grade Cleanrooms
With aseptic powder transfer technology
Contamination control is one of the most critical challenges pharma manufacturers face, mainly when producing drugs in sterile injectable dosage form.
Any raw product or formulation contamination can cause catastrophic results to the operator, patient, product and manufacturer’s reputation.
Sterile drug production has typically relied on cleanrooms to reduce the risk of contamination. However, this approach can be challenging and costly to maintain, particularly as there is an over-reliance on operators, which has proved to be the leading cause of contamination.
This informative whitepaper explores why the pharma manufacturing industry is shifting toward using techniques that isolate the sterile drug production process from the operator, keeping smaller areas at Grade A (ISO 5) and working within larger, lower-grade C or D cleanrooms.
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