ISO/FDA Consultation

If You Answer "Yes" To Any Of The Following Questions …..

Are you currently buying ready-made Biological Indicators (BI's) or Self-contained Biological Indicators (SCBI's) for your sterilization monitoring? BIoCI can verify the label claims for you per FDA or ISO requirements to assure that your purchases meet your processing and quality control requirements. We offer:

- Population and purity assays.
- D-value and Z-value determination studies.
- Survival / Kill time verification tests.
- Reduced Incubation Time (RIT) validation studies.

Would you like BI's or Process Challenge Devices (PCD's) custom-made to fit your specific needs? BIoCI can develop, validate and manufacture monitoring devices for your sterilization process. We offer:

- Spore suspensions (B.subtilis or B.stearothermophilus) with population levels from 101 to 109.
- Microbial suspensions of bioburden isolates at specified population levels.
- Inoculated products with specified organisms at requested population levels.
- BI's of desired sizes and materials at specified population/resistance levels.
- BI's or SCBI's for sterilization of solutions or dry powders.
- PCD's of desired configurations with requested population and/or resistance levels.

Do you need a fast and reliable testing laboratory for your QC programs? BIoCI is ISO 9001 certified with a fully equipped microbiology laboratory staffed by highly trained personnel. All testing is performed under GLP guidelines. We offer:

- Sterility testing of products, BI's, SCBI's, PCD's after sterilization exposure.
- Product Bioburden enumeration and/or identification.
- Microbial testing of water.
- Bacteriostasis and fungistatsis tests.
- Prepared culture media for microbiological testing.

Can we assist in your Environmental Monitoring Programs? BIoCI can help you in the development and enforcement of your environmental monitoring programs. We offer:

- Environmental Bioburden enumeration and identification (microscopic and biochemical profiles).
- Stock culture maintenance of environmental isolates.
- Cleaning, decontamination, disinfection process validation studies.
- Preparation and Growth Promotion testing of the culture plates used in environmental monitoring.
- Interpretation and trending of environmental data.

May we help with your product or process validation? BIoCI's sterilization experts can help you to validate your sterilization, disinfection, decontamination, and cleaning processes. We offer:

- Technical and Regulatory consultation for validation, 510k/PMA, GMP and ISO compliance.
- Cycle development, validation protocol generation, testing, and final report.
- Validation of cleaning and/or sterilization instructions for devices reprocessed by health care facilities.
- Validation of packaging for terminally sterilized devices.
- Product stability and shelf life determination studies.

….. Then Contact BioCi Immediately - Let's Work Together