Selecting a supplier for biological indicators (BIs) is critical to the success of any sterility assurance program. Selecting the appropriate indicator is not enough, you must partner with an experienced manufacturer that can help you sustain a defensible audit trail as well as provide regulatory and technical support when needed.
Here are 5 critical areas to explore when qualifying a BI supplier:
- Experience: Whether you are in a highly regulated and audited industry or not, it is extremely important to make sure that the biological indicators and BI manufacturer have a proven track record not just with customers, but with the regulatory agencies that you may be answering to. Mesa possesses extensive experience not only in BI manufacturing, but in global BI distribution and technical support. With close to 100 years of combined manufacturing expertise, Mesa’s biological indicator products have been used all over the world in several different industries, processes, and sterilization methods. We have conducted countless contract studies and developed specialized indicators for dozens of manufacturers all over the world. From that experience, Mesa has become one of the world-premier resources and experts in biological indicator use and development.
- Documentation: Trusting a supplier is more than just a hunch. In a regulatory environment (where “In God We Trust, All Others Must Document”), you need assurances that your supplying partner can provide necessary documentation when requested to support your auditing needs. In an effort to support lean manufacturing, having a defined continuous improvement program can also be beneficial to BI users. All of Mesa’s employee training records, equipment validation and qualification, and internal audits are tracked within our documentation control system making it easy to retrieve specific records, but more importantly to ensure the consistency of the manufacturing process and the end products.
- Certification to ISO 13485: Critical to the consistent deliverability of quality biological indicators, this ISO standard outlines all the crucial quality aspects one should demand of their BI manufacturer. Compliance to ISO 13485 is perhaps the most important aspect one should consider when qualifying a BI supplier. Mesa’s ISO certificates can be found online at https://mesalabs.com/certifications/.
- FDA registered: Not every BI manufacturer needs to be a FDA registered facility, however having to be held accountable to the US Food and Drug Administration does require a manufacturer to maintain a certain set of standards if it is going to supply indicators to the US healthcare market. The FDA can shut down and lock the doors of a facility if the manufacturing practices and documentation do not pass their stringent expectations, even if not all indicators are subject to review. Mesa’s FDA registration documentation can also be found at https://mesalabs.com/certifications/.
- Technical Support: Mesa manufactures dozens of different biological indicator products due to the varied processes in which sterility assurance is required. Mesa’s BI technical support team is not only experienced (decades of BI experience) but is responsive and easy to contact. Whether via email (firstname.lastname@example.org, MesaFrance@mesalabs.com (Europe), email@example.com (Canada)), live chat through our website at http://biologicalindicators.mesalabs.com/, or over the phone, our experts will be able to assist you in selecting the appropriate BI product for your unique process.
Establishing a reliable and experienced biological indicator manufacturing partner is worth the time and effort required to investigate the items mentioned above. To learn more about Mesa and our capabilities, contact us today!
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