Advance Care Pharmacy prepares sterile custom-made prescriptions in a state-of-the-art clean room. All sterile compounding is performed by trained and skilled personnel. We recognize the importance of controlling the quality, or cleanliness, of the environment in which the sterile products are prepared. Our laminar-airflow workbench is certified as ISO Class 5, as required by USP Chapter <797> standards of practice. This workbench is located in a buffer area (ISO Class 7) with strict air conditioning and humidity controls in place. Environmental monitoring is accomplished through air and surface sampling to ensure that microbial contamination is not present. All clean areas are certified every six months by a licensed agency.
What is USP Chapter <797>?
On January 1, 2004, USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, was implemented. It details the procedures and requirements for making compounded sterile preparations (CSPs) and sets standards that are applicable to all practice settings in which sterile products are compounded. The intent of Chapter <797> as described in the introduction is “to prevent harm, including death, to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, variability in the intended strength of correct ingredients, unintended chemical and physical contaminants, and ingredients of inappropriate quality in CSPs”. These standards are adopted and enforced by the California State Board of Pharmacy and accreditation organizations.
Advance Care Pharmacy compounds a wide variety of sterile products including:
- Pain Medications
- Total Parenteral Nutrition (TPN)
- IV Admixtures