Brief Company Description
BIoCI Systems, Inc. is a biotechnology company specialized in decontamination and sterilization sciences. The co-founders of the company have over 35 years of combined expertise in the design, validation, manufacture, regulatory requirements, QC testing of infection control processes and sterility assurance devices. BIoCI is strategically located in the Research Triangle area of North Carolina and work closely with leading research medical centers, such as the Duke University Medical School.
With its fully equipped testing laboratories, BIoCI offers more than just technical and regulatory consultations to help customers through the mazes of FDA, ISO, EN regulations and requirements. BIoCI Laboratory Services provides fast and reliable contract laboratory testing that takes validation, QC/QA worries out of customers' hands. Our laboratory services include:
- Validation studies for sterilization processes, including Reduced Incubation Time studies.
- Validation of cleaning/sterilization instructions for reusable devices for healthcare facilities.
- Verification of product sterility, and label claims of sterility assurance devices.
- Stability and shelf life tests of sterile products and sterile packaging.
- Environmental monitoring limits, and Bioburden enumeration / isolation / identification.
Success by Quality, Integrity, and Creativity is the motto we live by! At BIoCI, we believe that true customer satisfaction can only be obtained by the delivery of reliable, innovative products and highest quality services to our customers in a timely manner. We take quality seriously! BIoCI is not only in full compliance with the FDA's cGMP (QSR) for medical devices, it also became ISO 9001 registered within its first year of operation. Our strict adherence to these standards is our way of demonstrating our quality commitment to our customers, our partners, our regulators, and ourselves.
In addition, BIoCI also has the manufacturing capacity to custom-make biological indicators (BI), self-contained biological indicators (SCBI), and process challenge devices (PCD) to meet customer's specific product and regulatory requirements. In the design phase, BIoCI is committed to full compliance with the design control requirements of the FDA and ISO, so that quality is designed into the product. During manufacturing, BIoCI will adhere to all FDA and ISO requirements for production and process control to assure consistent product quality and performance. These, combined with QC testing in our laboratory prior to product release, assure our customers the highest quality products for monitoring the efficacy of their sterilization processes. Our manufacturing capacities include:
- Spore, bacterial or fungal suspensions with specified population levels.
- Spore inoculated on customer-specified carrier material at requested population and resistance levels.
- Self-contained biological indicator for moist heat sterilization of solutions.
- Indicator organisms in forms of dry powders.