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Supporting regulatory compliance with qPCR-based sterility testing
In biopharmaceutical production, maintaining stringent sterility standards is crucial. The integration of qPCR-based testing offers an enhanced level of scrutiny beyond traditional growth-based sterility testing methods. This advanced approach can serve as a rapid risk assessment tool, effectively measuring bacterial and fungal DNA in test samples.
The SteriSEQ system is designed to support recommended qualification guidelines from regulatory bodies:
- International Council for Harmonisation (ICH)
- United States Pharmacopeia (USP)
- European Pharmacopoeia (Ph. Eur.)
- Japanese Pharmacopoeia (JP)
Quick results when time is critical
When time is of the essence, the SteriSEQ Rapid Sterility Testing Kit stands out by offering quick and reliable results. This capability is particularly valuable during raw material or in-process testing, where early detection of potential contamination events is essential. By identifying contamination early, production teams can take timely corrective actions, enabling the integrity and safety of the final product.
Regulatory guidelines
USP <71>: This sterility testing is used to determine the absence of viable microorganisms in pharmaceutical products, medical devices, and other sterile products to ensure their safety and quality.
USP <1071>: It is widely recognized that the current growth-based sterility tests with an incubation period of at least 14 days are not suitable for products with a short shelf-life or for products prepared for immediate use, which are usually infused into patients before the completion of the test. These short-life products include cell and gene therapies, which require a new generation of risk-based approaches that include rapid microbial tests. [1]
Reference
1. United States Pharmacopeia (2023). General Chapter, <1071> Rapid microbial tests for release of sterile short-life products: A risk-based approach. USP-NF. Rockville, MD:
Applications for raw material and in-process testing
The SteriSEQ Rapid Sterility Testing Kit is designed to be versatile, making it suitable for both raw material and in-process testing. During raw material testing, the SteriSEQ kit can detect whether incoming materials are free from contamination before they enter the production cycle. In-process testing helps monitor and control contamination risks throughout the production process, safeguarding the quality of the final product. The SteriSEQ Rapid Sterility Testing Kit is useful as a complement to compendial methods because it offers a fast, sensitive detection of microbial contamination, enabling early corrective actions and enhancing overall production efficiency and product safety.
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Supporting regulatory compliance
Incorporating qPCR-based testing into your sterility testing protocols aligns with recommended qualification guidelines and supports regulatory compliance. This dual approach—combining traditional growth-based methods with advanced qPCR technology—offers comprehensive monitoring and control of microbial contamination.
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