Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products


guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion.

Hospitals use a large quantity of compounded medications, most of which are injectables that must be made according to strict standards to ensure sterility. These include total parenteral nutrition, irrigations used during surgical procedures, ready-to administer dosage forms, chemotherapy, and antibiotic treatments. Nonsterile compounding includes customized dosage forms for special populations such as neonates, infants, and geriatric patients.

We at Aseptic Enclosures have developed a line of Pharmacy Planning and Conceptual Design services and Primary Engineering Control Devices, completely dedicated to assuring compliance with USP <797> and USP <800>.
Our Pharmacy Planning and Design services start from an on-site visit for an Aseptic Enclosures’ pharmacy design representative that comes and evaluates your facility’s day to day operations.
We first perform an engineering controls assessment/audit for general USP <797> and USP <800> compliance of any relevant physical clean space. A report will be provided for the Director of Pharmacy approximately two weeks after visit.


Also included is the formation of the conceptual design to improve the facility’s aseptic quality.
Our turn-over package of this type of service to provide detailed needs assessment that will include project scope, design requirements, manufacturing processes, and construction considerations resulting in a three-dimensional conceptual design with rough field dimensions included. This detailed conceptual design can be easily executed by the most cost efficient contractor you can find on the market.
What if the engineering controls at the facility need an upgrade?
Not to worry, we offer a wide range of custom equipment to meet USP 797 and USP 800 compliance, from compounding aseptic isolators to hoods and clean benches. Our XLTC product line offer solutions from multiple potential platforms to help create an environment that is also ergonomic, functional, efficient and cost-effective.

After evaluating your facility Design, Equipment and Day to Day operations, our pharmacy compliance specialist provide a report. If everything is compliant with the current regulations except for some of the day to day operations, regarding your pharmacy personnel behavior inside of the compounding areas; We got you covered too.
Our testing and training services include viable fingertip sampling, media fill testing, results and reports and finally garbing, gowning, aseptic technique training, proper cleanroom behavior training and written tests.

We specialize in working with hospital pharmacies and helping them implement USP <797> <800> protocol. Call us toll free at 800.418.9289. We are also affiliated with most of the major GPOs and provide to provide the most competitive pricing for such services on the market.

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