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Chapter 797 in Pharmaceutical Compounding – Sterile Preparations issued by the US Pharmacopeia () describes the guidelines, procedures and compliance requirements for compounding sterile preparations

Chapter 797 in Pharmaceutical Compounding – Sterile Preparations issued by the US Pharmacopeia () describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

The contents of Chapter 797 are applicable to a wide range of settings, including “health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs [Compounded Sterile Preparations] are prepared, stored, and dispensed.” The provisions of the chapter touch on many aspects of pharmacy operations, including: risk assessment, facilities design, equipment, materials storage, beyond-use dating, training, aseptic technique, quality assurance, end product testing, and environmental monitoring & control.

A Controlled Environment

USP 797 states that compounding should take place within an ISO Class 8 or better clean room (called a “controlled area”). The clean room must include an attached anteroom at the same air quality level (ISO Class 8) for movement of personnel and materials in and out of the clean room. Additionally, a “primary engineering control” providing ISO Class 5 or better air quality must be used to perform compounding activities. Primary engineering controls include traditional equipment such as clean benches and Class II Biological Safety Cabinets, which the USP chapter refers to collectively as LAFWs (laminar airflow workstations).

Building and operating a clean room can be an expensive and time-consuming proposition. Fortunately, pharmacies can also comply with requirements using a barrier isolator, also known as a glovebox.

How Pharmacy Glove Boxes Work

A glovebox isolator (or barrier isolator) provides a physical barrier between pharmacy personnel and the compounding activity. Traditional clean benches and biosafety cabinets have an open front access area, where there is the possibility that disruptions in the room airflow or poor aseptic technique by the operator will introduce contaminants to the work area. A glove box provides an additional level of protection, as the sterile product is never exposed to the room environment or to compounding personnel directly.

When using a glovebox, materials are passed into the main working chamber through an enclosed pass-thru chamber, and accessed through glove ports to perform aseptic manipulations. Clean air is supplied to the work area through a HEPA filter, providing better than ISO Class 5 conditions under positive pressure within the glovebox.

Benefits of Pharmacy Glove Boxes

Gloveboxes offer the same or better air quality as a clean bench or biosafety cabinet located within a clean room, plus their design offers some significant advantages in both initial investment and ongoing operating expenses. Notably:

  • Less space required: Clean rooms require both a main work area and an anteroom at ISO Class 8 air quality.
  • Lower startup costs: Clean rooms call for specialized materials and construction methods as described above.
  • Lower operating costs: Clean rooms require specialized clothing that is disposed of frequently, as well as specialized maintenance products and procedures.
  • Better working conditions: Personnel must “gown up” on entering and “un-gown” when leaving the clean room, and may not wear make-up or jewelry.
  • Greater sterility assurance: A physical barrier between the worker and the sterile product reduces the risk of introducing contaminants.

Chemotherapy and Other Hazardous Drugs

USP Chapter 797 speaks to aseptic conditions for compounded sterile preparations; however the chapter does not cover in detail the risks to pharmacy personnel associated with handling cytotoxic or other hazardous drugs. For these special cases of CSPs, a negative pressure glovebox should be used to provide ISO Class 5 conditions while also protecting personnel from exposure.

For More Information

Copies of USP Chapter 797 may be ordered directly from USP. The Baker Company has also created an online library of links to articles and studies relevant to current trends and standards in pharmacy compounding.

Go to the Pharmacy Resource Center