RapidCert™ is a novel rapid method of biological indicator (BI) sterility testing (patent pending) offered exclusively by Nelson Labs. RapidCert™ provides confirmation of sterility for lot release and sterilization validations in as little as three days.
Check out the key benefits of RapidCert™ BI testing:
Faster Results
RapidCert™ requires only 48 hours of incubation—compared to 7 days.
Objective, Instrument-Based Data
RapidCert™ relies on ATP bioluminescence and modern instrumentation instead of subjective visual inspections.
Flexibility with BI Types
RapidCert™ can be used with various BI types.
Easy Implementation
RapidCert™ does not require validation work from the customer; the validation has been done by Nelson Labs.
BI sterility testing is critical for helping ensure that a sterilization process effectively kills microorganisms in a sterilization load and that the products therein demonstrate an adequate sterility assurance level before being released for use on patients. BI testing is commonly used for sterilization processes that involve ethylene oxide (EO/EtO), steam, dry heat, and vaporized hydrogen peroxide. The testing is performed on BIs placed throughout a sterilization load and is commonly used for process validations and routine production lot releases.
Standard BI testing requires a 7-day incubation period after the BIs are removed from the sterilization load. With RapidCert™ BI testing the incubation time is reduced to 48 hours. Nelson Labs has already validated the rapid method for two common BI types inoculated with Bacillus atrophaeus, so there is an easy transition from the standard 7-day incubation to 48-hour incubation. Additional types of BIs can be validated upon request.
BI testing and sample requirements are outlined in numerous standards, including USP <55>, the ANSI/AAMI/ISO 11138 series parts 1-4 and part 7, ANSI/AAMI/ISO 14161, and ANSI/AAMI/ISO 11135. The rapid BI test method complies with guidance specifically for alternative methods, found in USP <1223> and PDA TR33.
Nelson Labs offers RapidCert™ BI testing 6 days a week. Samples are tested upon arrival, and the final reports are uploaded to our customer portal (secure website) once BIs are released from incubation Monday to Friday.
Applicable Standards
USP <1223>
ISO 11138 parts 1–4 and 7
Study Outline
With RapidCert™ BI testing the BIs are aseptically placed into soybean casein digest broth and incubated for the appropriate time and temperature, depending on the growth requirements for the indicator organism. The samples are typically incubated for 48 hours minimum at 30–35°C for Bacillus atrophaeus (EO or dry heat sterilization). Other incubation conditions may be validated upon request.
