Biological Indicator & Chemical Indicator Testing
HIGHPOWER can verify and/or validate the performance requirements of most biological and chemical indicators used in healthcare and industrial sterilization processes. We have in-depth knowledge of what’s required to produce, test, and market biological and chemical indicators gathered from over 35 years’ experience. Our biological and chemical indicator test methodology is based on the methods outlined in the United States Pharmacopeia/National Formulary and in the ANSI/AAMI/ISO 11138 and ANSI/AAMI/ISO 11140 series of standards. This includes testing in sterilization processes such as steam, VHP, dry heat, and ETO.
Testing can be performed in compliance with the FDA guidance documents “Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions and Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators.”
In addition to steam, dry heat, and ETO biological indicators, HIGHPOWER can verify and/or validate the performance requirements of most class 1, 4, 5 and 6 chemical indicators as listed in the ISO 11140-1 standard. Our test equipment meets the requirements listed in the ISO 18472 resistometer standard for steam, ETO, dry heat, and hydrogen peroxide resistometers.
Our test equipment meets the performance requirements listed in the ISO 18472 standard for steam, ETO, dry heat, and hydrogen peroxide resistometers.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| BI-ASSAY | Biological Indicator Population Verification
|
| BI-DV-DRY | Dry Heat Biological Indicator D-value Analysis |
| BI-DV-ETO | EtO Biological Indicator D-value Analysis |
| BI-DV-STEAM | Steam Biological Indicator D-value Analysis |
| BIO-BURDEN | Article Bioburden Test |
| BI-PURITY | Biological Indicator Purity Test BI-SK Survival/Kill Test for Biological Indicators |
| CI-ISO1 | Table 2 of ISO 11140-1 — Steam Chemical Indicators |
| CI-ISO2 | Table 3 of ISO 11140-1 — Dry Heat Chemical Indicators |
| CI-ISO3 | Table 4 of ISO 11140-1 — ETO Chemical Indicators |
| CI-ISO6 | Table 7 of ISO 11140-1 — VHP Chemical Indicators |
| RES-DRY | Dry Heat Resistometer Cycle |
| RES-ETO | EtO Resistometer Cycle |
| RES-STEAM | Steam Resistometer Cycle |
| RES-VHP | VHP Resistometer Cycle |
| STERILITY | Article Sterility Test |
| BI-STERILITY | Sterility Culturing of Biological Indicators |
Whether you are in the beginning stages of product development or performing final design control tests before filing for a USFDA 510(k) clearance, our biological indicator testing services are not only essential but also a necessary component to the release of a safe and effective product. If you don’t see your required procedure listed, please contact us at clientservices@highpowervtls.com with your inquiry.
