USP 797 & AirClean Systems Canada

Posted by : Kristina Covelli Lopez on

Compounding pharmacies are a critical, but often overlooked part of the healthcare continuum. Because of their direct impact on patient care, quality and safety are essential throughout these facilities.

Testing and quality standards for US facilities are addressed by the United States Pharmacopeial Convention; USP <797> provides guidelines for facilities in which compounded sterile preparations are prepared, stored and dispensed. Although USP 797 guidelines are not enforced in Canada, Health Canada recommends those engaged in sterile compounding should be knowledgeable and obtain specialized technical training in this area.**

What is USP 797? Does it apply to my pharmacy?
USP 797, the “Pharmaceutical Compounding – Sterile Preparations” chapter, outlines that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. If your pharmacy currently performs sterile compounding (or will be in the future), the new USP 797 chapter applies to you. There are many ways to meet USP Chapter 797’s requirements for a sterile compounding area – incorporating a laminar flow hood to an existing clean room environment can help you achieve USP 797 compliance as well as conserving valuable lab space.

Common sterile compounding applications involve:

  • injections
  • ophthalmic solutions
  • ointments
  • IV admixtures
  • inhalation solutions
  • allergens
  • bladder irrigating solutions

AirClean® Systems can help your pharmacy comply with USP 797.
According to USP 797, sterile compounding is to be prepared in an ISO 5 environment. AirClean® Systems manufactures ISO 5 vertical laminar flow workstations and horizontal laminar flow benches. Our workstations provide unidirectional airflow on the direct compounding area (DCA), which allows for optimum ‘first air’ contact with your application. Available in several sizes, AirClean® Systems laminar flow workstations are ideal for pharmacies looking for a USP 797 compliant containment solution for sterile compounding.
While both horizontal and vertical laminar flow workstations provide process protection in an ISO 5 environment, there are some differences between them. Which one is right for your pharmacy? It depends on your needs and the space you have available. Both styles are designed to fit on a standard bench top and plug into a regular 110V AC outlet. AirClean® Systems Horizontal Clean Benches are available in 52’’, 60’’, 72’’, and 102’’ widths. The Vertical Laminar Flow Workstations are available in 24’’, 32’’, and 48’’ widths.

USP 795: Operator Protection – for nonsterile preparations.
USP <795> outlines the responsibilities of the compounder, which can be summarized as being responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in compliance with requirements established by applicable laws and agencies. Specifically, the responsibilities of the compounder include the following general principles:

  • Personnel are capable and qualified to perform their assigned duties.
  • Compounding ingredients of the appropriate identity, quality, and purity are purchased from reliable sources.
  • All equipment used in compounding is clean, properly maintained, and used appropriately.
  • Only authorized personnel are allowed in the immediate vicinity of the drug compounding operations.
  • There is assurance that processes are always carried out as intended or specified and are reproducible.
  • The compounding environment is suitable for its intended purpose and to prevent errors.
  • Adequate procedures and records exist for investigating and correcting failures or problems in compounding, in testing, or in the preparation itself.

AirClean® Systems PowderSafe™ Type A enclosures provide an effective and safe environment when using powder weighing equipment in conjunction with toxic compounds or chemicals. A PowderSafe ductless fume hood provides your pharmacy with a distinct and accurate weighing environment for your non-sterile compounding.

Contact AirClean Systems Canada to see how one of our affordable ductless workstations can become part of your pharmacy’s action plan to be USP compliant.


** The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations”, which set a more rigorous and enforceable standard for sterile compounding in the United States.


Leave a Reply

Your email address will not be published. Required fields are marked *