Sterile compounding represents the most critical aspect of pharmaceutical compounding.
At PenCol Specialty Pharmacy, we are quite proud of the quality of our sterile compounding facilities, processes, and standards.
Examples of preparations that need to be compounded in a sterile environment include:
Proper ingredients, techniques, supplies, and facilities are needed to ensure the patient safely receives the correct medication. PenCol Specialty Pharmacy does this by the following methods:
PCAB Accreditation –PenCol Specialty Pharmacy submits 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, the PenCol facility must meet standards set forth in the United States Pharmacopeia Chapter <797>, considered a common quality standard for sterile compounding.
In addition, our facilities are inspected by the Colorado State Board of Pharmacy at least annually.
PenCol Specialty Pharmacy 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. We also take this a step further by sending our preparations to an independent 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 use-by-date assigned it.
- Staff Training – all staff involved in the preparation of sterile medications undergo extensive training before compounding sterile preparations. Our staff also undergo training, testing, and assessments of sterile garbing, aseptic practices, and cleaning techniques every six months.
- Facilities – PenCol Specialty Pharmacy utilizes a cleanroom for the preparation of sterile medications. In a cleanroom all the 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 testing company to ensure proper function. All other equipment is certified annually by outside experts.
PenCol Specialty Pharmacy in Denver, Colorado is proud to provide the highest quality sterile compounding for our human and veterinary patients.