Sterile compounding represents the most critical aspects of pharmaceutical compounding.
Examples of products that should be prepared in a clean environment comprise:
Technique, suitable elements, supplies, and facilities are needed to ensure the patient receives ideal medication in a safe manner. United Pharmacy does this by these processes:
PCAB Accreditation – among the few pharmacies in America to receive this distinction, United Pharmacy submitted itself to rigorous testing against standards created by leading experts in the field of compounding (find additional information at http://www.pcab.org). 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 involving sterile compounding.
Product Testing – United Pharmacy keeps routine testing of both sterile and non-sterile products. For sterile preparations, testing is done on multiple criteria:
Sterility and Endotoxin – products are tested for sterility internally using dual media according to USP guidelines. We also take this a step further by sending our medications to an outside lab for third party sterility and endotoxin evaluation.
Potency – we validate by third-party investigation. This ensures that your medication is right at the labeled potency within the beyond-use date.
Facilities – United Pharmacy utilizes a “cleanroom” for preparation of sterile products. In a cleanroom all air is pulled in through HEPA-filters, creating an environment that is a lot lower in particulate that can cause a preparation to be contaminated. Within the cleanroom is a laminar airflow workbench which supplies a second wave of clean air to work in. Air quality testing is done on a weekly basis, and the cleanroom and laminar airflow workbench are certified biannually by a third party to make sure appropriate function.
Staff Training – all staff involved in the preparation of aseptic products undergo extensive training prior compounding sterile products.
United Pharmacy in West Palm Beach, FL is proud to provide the maximum quality sterile compounding for our physicians, our individual and veterinary patients.
Author: Kirill Vesselov
Kirill Vesslov is our resident writer about health and wellness as well as our pharmacy services.