Here at Columbia Compounding we are proud to provide the highest quality sterile compounding for our human and veterinary patients. Sterile compounding is a specific critical subset of compounding that requires proper facilities and rigorous testing to ensure the patient not only receives the correct medication but in a safe manner. Categories of sterile compounds at our facility include:
Columbia Compounding maintains regular testing of both sterile and non-sterile preparations. Sterile compounding has to comply with a special chapter of the United States Pharmacopeia (USP), which has guidelines for:
- Sterility and Endotoxin – Preparations are tested for sterility via a third-party facility according to USP chapter 797 guidelines to remove any conflict of interest.
- Potency – We validate potency by third-party analysis. This ensures medication is at the labeled strength within the beyond-use date assigned it and complies with USP <797>.
- Facilities – Columbia Compounding utilizes an ISO 7 class cleanroom for preparation of sterile medications. In a cleanroom, all air is pulled in through HEPA-filters, creating an environment that is much lower in contamination causing particulate. Within the cleanroom is an ISO 5 class laminar airflow workbench which further filters the air through a secondary HEPA filter. Not only is the cleanroom routinely cleaned per USP <797> requirements but undergoes air quality testing/certification by a third-party for both the cleanroom and laminar airflow workbenches bi-annually.
- Staff Training – All staff must undergo additional aseptic technique training prior to compounding sterile preparations. Our staff has been certified by LP3 network and undergoes continued education.