Sterility

Confirming sterility is a key concern for both medical device and pharmaceutical products.  iuvo specializes in the microbiology associated with compendial sterility, including USP 71 and ISO 11737-2, with special emphasis on medical devices, ocular products, pharmaceuticals and a wide variety of Biological Indicators used in the device sterilization industry. Our team has extensive experience with the increasing complexity of medical devices, employing a broad range of techniques to evaluate different products (drop methods, membrane filtration, fluid path).

iuvo has decades of experience in studies employing ethylene oxide, steam, dry heat and liquid chemical sterilants, along with electron-beam and gamma-irradiation dose validation studies. As part of our ISO 17025 accredited testing services, our technical staff maintains a high level of expertise by participating in annual training and recertification processes. All of our sterility procedures are performed in a certified cleanroom, including a transfer room that has been classified to ISO Class 7 specifications, within which we perform our transfers in an ISO Class 5 laminar flow hood.

In addition to the many engineering controls, all procedures are strictly controlled to minimize contaminants in the environment where transfers take place. Technique is critical to maintaining reliable testing, since any contamination can ruin a test and operators are always the most common source of contamination.  The state of control is evaluated routinely through environmental, personnel and fall-out monitoring to ensure functionality is maintained and meets the requirements specified for cleanrooms in ISO 14644-1 and ISO 14644-2.

Tests

Bacteriostasis/Fungistasis Test (USP)
Embedded Spore Strip
Innoculated Product Immersion
Membrane Filtration Test (USP)
Product Immersion (USP)
Spore Strip Test