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PATIENT SAFETY THROUGH USP CHAPTER 797

Introducing the A2 Pharmacy Isolator to hospital and clinical pharmacies to help them meet USP <797> requirements.

What is USP <797>?

USP <797> deals with policies and practices for compounding sterile preparations. A compounded sterile preparation (CSP) is a dosage unit with any of the following characteristics:

• Preparations prepared according to the manufacturer's labeled instructions
• Preparations containing non-sterile ingredients or using non-sterile components or devices that need to be sterilized before use
• Biologics, diagnostics, drugs, nutrients, and pharmaceuticals that match either of these characteristics

Examples include baths and soaks for live organs and tissues, implants, inhalations, injections, powder for injection irrigations, metered sprays, and ophthalmic and otic preparations.

USP <797> took effect on January 1, 2004. It is the first official and enforceable requirement for CSPs. By setting standards, requirements, and procedures for CSPs, USP <797> reduces the potential for contamination caused by an unclean environment, pharmacist error, lack of quality assurance, incorrect beyond-use dating, and other factors. Some specific issues USP <797> address include:

• The responsibility of compounding personnel to ensure that CSPs are prepared, stored, dispensed, and distributed safely
• Contamination risk levels
• Procedures to verify the accuracy and sterility of CSPs
• Personnel training and evaluation
• Verification of Automated Compounding Devices (ACDs)
• Environmental quality and control
• Checks and tests of finished preparations before dispensing
• Storage and beyond-use dating
• Product quality and control after the CSP leaves the pharmacy
• Patient or caregiver training so they can store, administer, and dispose of the CSP
• Patient monitoring to track their response to the therapy
• The need for a feedback mechanism so patients and caregivers can report concerns about CSPs
• A quality assurance program that documents CSP policies, processes, and procedures

Ultimately, USP <797> protects patients from harm, injury, and even death. Through USP <797>, you can identify where failures could occur during a compounding process and implement methods to control and monitor these critical points.

How can the A2 Pharmacy Isolator help you meet USP <797> requirements?

The environmental and quality control section of USP <797> specifies the physical and environmental requirements for safely preparing CSPs. The requirements include the need for cleanrooms or barrier isolators. Unfortunately, few pharmacies have such a compounding environment, and with the cost of installing a cleanroom starting at $150/square foot, their cost can be prohibitively expensive. In addition, cleanrooms may have high operating costs and take up valuable floor space.

The A2 Pharmacy Isolator provides an excellent alternative to a cleanroom. It provides the same level of air quality a cleanroom does, while taking up less space and being more cost-effective to operate. Even better, the A2 Pharmacy Isolator is easy to use, easy to clean, and easy to sanitize. It is fully adjustable, making it comfortable to use, and includes an Uninterruptible Power Supply (UPS), making it safe and reliable.

With the A2 Pharmacy Isolator, materials are placed in a transfer chamber that acts as an air lock. The ventilation system then cleans the air in the background chamber up to class 100 quality. Once this step is complete, the compounder can work through gloves in a guaranteed safe environment. The A2 Pharmacy Isolator thus serves as an actual barrier between the compounder and the CSP.

The A2 Pharmacy Isolator has several unique features:

• It is made of a one-piece stainless steel unit, making it easy to sanitize
• Electronic controls monitor negative and positive pressure, the air change rate, the integrity of vacuum systems, the electrical supply, and leaks
• Electronic controls open and close the doors and adjust the height
• Air quality in the main chamber automatically adjusts to the required level before the door to the chamber opens. Built-in validation ports also assess the air quality
• The main window and access ports have a quick-release valve system, offering immediate access for sterilization and validation

Pharmacies need to adjust their policies and practices to meet USP <797> requirements. As you analyze the changes you need to make in your facility, remember that the A2 Pharmacy Isolator will solve environmental and quality control issues, moving you towards compliance and protecting the health and safety of your patients.