Sterile compounding represents the most critical aspects of pharmaceutical compounding.
Examples of products that need to be prepared in a sterile environment include:
Proper ingredients, technique, supplies, and facilities are needed to ensure the patient receives correct medication in a safe manner. Central Compounding Center in Durham does this by the following methods:
PCAB Accreditation – among the first 50 pharmacies in the United States to receive this distinction, Central Compounding Center South submitted itself to rigorous testing against standards created by leading experts in the field of compounding (find more information at http://achc.org/pcab). As part of PCAB accreditation our facility must meet standards set forth in the United States Pharmacopeia Chapter <797>, considered the most stringent set of guidelines regarding sterile compounding.
Central Compounding Center South maintains regular testing of both sterile and non-sterile preparations. For sterile preparations, testing is done on multiple criteria:
- Sterility and Endotoxin – preparations are tested for sterility internally using dual media according to USP <797> guidelines. We also take this a step further by sending our preparations to an external laboratory for third-party sterility and endotoxin analysis.
- Potency – We validate potency by third-party analysis. This ensures that your medication is at the labeled strength within the beyond-use date assigned it.
- Facilities – Central Compounding Center South utilizes a “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 particulate that can cause a preparation to be contaminated. Within the cleanroom is a laminar airflow workbench which provides a second wave of clean air to work in. Air quality testing is done internally on a weekly basis, and both the cleanroom and laminar airflow workbench are certified bi-annually by a third-party to ensure proper function.
- Staff Training – all staff involved in the preparation of sterile medications undergo extensive training prior compounding sterile preparations.
Central Compounding Center South in Durham, North Carolina is proud to provide the highest quality sterile compounding for our human and veterinary patients.