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Innovative Technology's A2 Pharmacy Isolator meets Compliance with USP Chapter <797> for Compounding Sterile Preparations / Pharmaceutical Compounding

The United States Pharmacopeia (USP) Chapter <797> establishes requirements for the process known as compounded sterile preparation (CSP). A CSP is defined as a unit of dosage with one or more of the following characteristics:

• A preparation prepared in accordance with manufacturer's labeling and instruction
• A preparation containing non-sterile (microbial) ingredients
• A preparation that makes use of components or devices that must be sterilized prior to use
• Drugs, biologics, nutrients, diagnostics and pharmaceuticals that have any of the above characteristics.

The requirements are applicable to all healthcare settings and are used to establish standards by which pharmacies may be inspected and accredited. Traditional methods of compounding were found to be cause for patient injuries and death. The U.S. Food and Drug administration (FDA) is granted authority to enforce such standards when there is suspicion of injury or death from compounding.

Chapter <797> is but part of the USP 27/National Formulary (NF) 22 reference. Chapter <797> is intended to address the prevention of harm and fatalities to patients resulting from microbial contamination, excessive bacterial endotoxins, incorrect ingredients in CSPs and content error in the strength of CSP ingredients. Chapter <797> includes a checklist to be used in determining the level of risk for a particular pharmacy's compounding operations. Risk levels, low, medium and high are base lined with respect to potential microbial, physical and chemical contamination. The chapter further establishes requirements to identify and prioritize practices that are cause for the particular risks as well as requirements for developing an action plan to reduce or eliminate the risks. The purpose of Chapter <797> is to identify operating deficiencies in CSP and to provide guidelines for establishing corrective actions to reduce both microbial contamination and inaccuracies in pharmacy compounding.

Components of USP Chapter <797>

The content of Chapter <797> of USP 27/NF 22 provides an exhaustive listing of information, requirements and nutritional supplements. Ongoing research and technological innovations will necessitate changes in the standards as adopted and published in January 2004. To assist health care pharmacists with the implementation of current Chapter <797> requirements, the American Society of Health System Pharmacists, in conjunction with Baxter Healthcare Corporation, developed and published a discussion guide for CSPs. The guide presents a summary of implementation procedures and requirements as understood at the time of publication. The guide highlights thirteen major components of USP <797> as follows:

1. The Responsibility of compounding personnel in ensuring that CSPs are accurately identified, measured, diluted, mixed, purified, sterilized, packaged, sealed, labeled, stored, dispensed and distributed.
2. The compounder's responsibility to determine the microbial contamination risk level.
3. Verification of CSP compounding accuracies and sterilization methods.
4. Training of all pharmacy personnel in aseptic manipulation with follow-on evaluations.
5. Environmental quality control of the physical space used for compounding, defined for each specific risk level.
6. Documenting an employee training and evaluation program for CSP preparation.
7. Verification of automated compounding devices (ACDs) as used for parenteral nutrition compounding.
8. Post preparation release checks and tests.
9. Storage and beyond-use dating, defined for each specific risk level.
10. Maintaining quality control after the CSP leaves the pharmacy.
11. Training for patient caregivers in the dispensing of CSP as well as monitoring and reporting patient responses.
12. Monitoring patient responses and reporting adverse events.
13. Documenting training methods and procedures for quality assurance.

Compliance with the use of an A2 Pharmacy Isolator

Innovative Technology's A2 Pharmacy Isolator has application in the "environmental quality control of the physical space used for compounding", as specified as component 5, in the above section. Specifically, the A2 Pharmacy Isolator is a barrier isolator. A barrier isolator, as defined by the Food and Drug Administration, is "a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding clean room air and personnel". The A2 Pharmacy Isolator is such a unit. Chapter <797> requirements dictate that the cleanliness of the air, in a compounding environment, is critical in reducing the likelihood of microbial contamination. The A2 Pharmacy Isolator provides a cost effective method to meet the physical and environmental requirements for reducing contamination when preparing CSPs. The A2 Pharmacy Isolator has the following characteristics, which put it in compliance with Chapter <797> requirements.

Ventilation: A turbulent airflow system, with both positive and negative air pressure options, is used to reduce airborne pollutants and infections. The isolator mixes filtered air with airborne contaminants, which are flushed out through the air extraction system. Air pressure is used to keep external airborne particles out of the isolator

Isolation: A pass-through system is used to separate the general pharmacy from the compounding area. An air-lock transfer chamber is used to transfer items in and out of the main isolator chamber. Doors to the transfer chamber and main isolator chamber are interlocked to prevent both doors from being open at once. The timed interlock may be set in 10-second intervals. The time delay from closing the outer door of the transfer chamber to opening the door to the main isolator chamber is automated to provide time for the ventilation system to clean the air to ISO Class 5 classifications (formerly, Class 100).

Exposure: Both the transfer chamber and main isolation chamber provide ISO Class 5 environments for CSP exposure. Automation provides that the system cleans the air in the transfer chamber up to ISO Class 5 classification before access to the compounding area is allowed.

Buffer Area: Requirements do not insist that a buffering area (or clean room) be used with an isolator. The requirements insist that the isolator be housed in an environment that is as clean and sterile as possible. The A2 Pharmacy Isolator's transfer chamber eliminates the need for a buffer area by providing the capability to clean the background air before transferring items to the main isolation chamber for compounding.

Maintenance: The isolator is made of durable, easy to clean materials, which include stainless steel, glass and high-performance plastics. The complete unit is constructed of one piece of stainless steel with rounded corners for easy cleaning. There are no joints, crevices, hinges or clamps to create points of contamination. The chamber doors are lightweight and vacuum-sealed. All inside surfaces may be reached and sanitized from glove ports. The unit has wide, clear openings and offers electronic height adjustments for easy cleaning and a roller frame for portability. Inlet filters require changing every 2 to 3 years while extract filters require changing every 5 years.

Garbing: The main isolation chamber is a closed area to which access is provided only with the use of sealed gloves. This eliminates the time and expense of specialized garbing and also eliminates any contamination caused by humans, the largest source of contamination. The system provides a double-glove system so that leaks and tears in the glove do not compromise the environment within the isolator. Any gloves with rolled ends, which are currently used in hospital settings, can be worn underneath the sealed gloves provided with the A2 Pharmacy Isolator.

Procedures: The isolator includes approved procedures and policies for the activity performed within the unit. The certifying authority is Amercare, a leading developer of isolators and isolator technology. Amercare meets the requirements of ISO9001 for quality management and system standards. The isolator is CE certified for use in Europe.

Monitoring: Key isolator functions are backed with an uninterrupted power supply (UPS) and a digital alarm system. Electronic controls are used to monitor the isolator's functions, which include

• The opening and closing of chamber doors
• Negative and positive pressure
• Air change rates in both the transfer and main chambers
• The integrity of vacuum systems with a back-up pump to be used in the case of failure.
• The electrical supply with an audible alarm to indicate failure.
• Leaks in the unit.