STEMart Launches Biological Indicator-Population Verification Testing Service for Medical Devices
STEMart introduced the Biological Indicator-Population Verification testing service that can be applied to all types of biological indicator configurations.
- (1888PressRelease) September 28, 2022 - STEMart, a US-based provider of comprehensive services for all stages of medical device development, has recently introduced the Biological Indicator-Population Verification testing service following the guidance of ISO11138 and the United States Pharmacopeia (USP) General Chapter. This testing can be applied to all types of biological indicator configurations, such as BI strips, stainless steel sutures, inoculated wires, and spore suspensions.
The Biological Indicator Population Validation test determines the number of spores on a biological indicator (BI). It is often used to confirm that the BI manufacturer’s stated value is representative of the batch. Additionally, biological indicators can provide worst-case cell sterilization solutions by applying organisms resistant to the sterilant used in a particular application. This test can also be used to identify survivors during sterilization and to calculate lethality rates and D-values.
Initial BI Population Verification is necessary as the quantity of BI may change during shipping or storage. Population enumeration of samples exposed to sterilants is also important because it provides quantitative data, whereas BI sterility testing only provides results with or without growth. In addition, all major pharmacopeias recommend population validation for each batch of biological indicators. This provides a degree of assurance for the variables declared by the manufacturer.
The general procedures for Biological Indicator Population Verification testing include softening the BI in the liquid using a validated technique; applying a heat shock technique to the softened liquid and diluting the suspension to produce a range of colonies of colony-forming units; and finally electroplating.
STEMart now offers Biological Indicator Population Verification testing services as directed by ISO11138, USP or manufacturer’s instructions. Both the ISO 11138 and the United States Pharmacopeia (USP) General Chapter provide guidance for conducting BI population verification testing to determine the number of spores on a BI. STEMart can test all types of biological indicator configurations, including but not limited to BI strips, stainless steel sutures, inoculum lines and spore suspensions.
STEMart offers comprehensive sterility tests for sterile and non-pyrogenic products. With extensive expertise in Microbiology & Sterility testing, STEMart can provide a full-service experience, support manufacturers to meet regulatory goals, and minimize compliance risks. Its engineers, physicists, industrial designers, regulatory and manufacturing experts will work with customers to ensure the best possible results.
If you have additional questions about Biological Indicator-Population Verification testing service for medical devices or would like to know more about STEMart’s medical device development service, please visit https://www.ste-mart.com.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer in order to enhance better health worldwide.
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