The Highest Quality Compounding
Sterile compounding, as you may guess from the title, is the highest quality of non-contaminated compounding available in the industry. At Rx3 our sterile compounding is held to a strict list of environmental conditions set by the United States Pharmacopeial Convention. Sterile, does not simply mean “clean” in the traditional sense. We undergo rigorous procedures to make sure our compounding environment is exceptionally sterile, to produce the safest and highest quality medication available.
Sterile Compounding Policies & Procedures
At Rx3 Pharmacy we have a specially designed Clean Room, designated for sterile compounding. Our pharmacists prepare medication according to Chapter 797, which lays out the regulatory standards for sterile compounding preparations. These procedures include:
- Lab testing of finished products, both in-house and independently
- Monitoring with environmental microbiology sampling
- Monitoring the particle count of the sterile environment
- Proper cleaning and maintenance routines
- Routine outside certification of our laminar flow hood
- Routine testing of our pharmacy staff's sterile technique
- Proper staff grooming and gowning before entering critical sterile areas
These procedures ensure that your medication is properly and safely prepared and will not contain any allergens or outside contaminants.
Medications that Require Sterile Compounding
Sterile compounding is incredibly important for some medications, especially those meant to treat sensitive areas of the body including the blood stream, the eyes, the lungs or the heart. The pharmacists at Rx3 often sterile compound medications such as:
- Ophthalmics, Such as Eye Drops & Ointments
Sterile Compounding: A Measure of Our Commitment
Maintaining a sterile environment requires a constant, ongoing commitment to quality and safety. This is the commitment Rx3 Compounding Pharmacy makes to you. Please contact us to learn more about Rx3 Compounding Pharmacy sterile compounding.
Sterile Compounding Standards
A pharmacy preparing sterile preparations must design its facilities to provide for: minimization of interruption, avoidance of contamination, and an exclusive area for the compounding of sterile preparations. Policies and procedures shall be established for periodic environmental testing to assure continued adequacy of the aseptic environment.
- The pharmacy’s written policies and procedures outline mechanisms adequate for minimizing interruption during compounding.
- The pharmacy’s written policies and procedures outline mechanisms adequate for avoiding contamination by dust and other particulates in the aseptic compounding area.
- The pharmacy’s written policies and procedures outline mechanisms adequate to reduce the potential for contamination or adulteration of the compounded preparations.
- Pharmacy policies and procedures outline procedures for periodic environmental testing of the aseptic environment.
- Pharmacy meets state law requirements as to sterile compounding.
- If the pharmacy practices aseptic sterile compounding, it has an appropriate area for compounding of aseptic preparations that meets or exceeds USP <797>.
- Consistent with Standard 9, Quality Assurance, pharmacy has policies and procedures to monitor and test, as applicable according to USP <797>, sterile compounded preparations for sterility, pyrogenicity and potency.