Sterile Compounding

Rx3 Compounding Pharmacy Sterile Compounding: Quality and Peace of Mind

In the pharmaceutical field, sterile does not simply mean clean. Sterile is an exacting standard, a strict list of environmental conditions set out by our industry's ruling body, the United States Pharmacopeial Convention. Sterile is your assurance of safety and quality.

Rx3 Compounding Pharmacy offers you a variety of customized sterile medications, including:

• Injectables
• Ophthalmics, Such as Eye Drops & Ointments
• Inhalations

Sterile Compounding: Strict Policies and Procedures

These medications are compounded in our specially designed and constructed Clean Room. In this environment, Rx3 Compounding Pharmacy's skilled pharmacists and pharmacy technicians prepare your medications according to Chapter 797, the regulatory standard for the compounding of sterile pharmaceutical 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

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.

Compliance Indicators

1. The pharmacy’s written policies and procedures outline mechanisms adequate for minimizing interruption during compounding.
2. The pharmacy’s written policies and procedures outline mechanisms adequate for avoiding contamination by dust and other particulates in the aseptic compounding area.
3. The pharmacy’s written policies and procedures outline mechanisms adequate to reduce the potential for contamination or adulteration of the compounded preparations.
4. Pharmacy policies and procedures outline procedures for periodic environmental testing of the aseptic environment.
5. Pharmacy meets state law requirements as to sterile compounding.
6. If the pharmacy practices aseptic sterile compounding, it has an appropriate area for compounding of aseptic preparations that meets or exceeds USP <797>.
7. 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.