USP 797 and how it affects Compounding Pharmacies

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The revised USP regulation 797 went into effect on January 1, 2004. Compounding Pharmacies will feel a direct and immediate impact as the regulation refers specifically to "...health care institutions, pharmacies, physician's practice facilities and other facilities in which compounded sterile preparations are prepared, stored and dispensed." In order to be in compliance with the new rules, such institutions will need to protect their products by utilizing a Laminar Airflow Workbench (referred to by the USP as LAFWs) within a cleanroom.

The text of the new regulation allows for the same requirements to be met through the use of a Compounding Aseptic Isolator:

"In general, sterile product preparation facilities utilize laminar airflow workbenches (LAFWs) to provide an adequate critical site environment…The use of alternative systems in clean rooms that have been verified to achieve the same or better level of environmental quality as that achieved by properly operated LAFWs may also be utilized. An emerging technology utilizes barrier isolator systems to minimize the extent of personal contact and interaction, to separate the external environment from the critical site, and to provide an ISO Class 5 environment for preparing Compounded Sterile Preparations (CSPs). A well-designed positive pressure barrier isolator, supported by adequate procedures for its maintenance, monitoring and control, may offer an acceptable alternative to the use of conventional LAFWs in clean rooms for aseptic compounding."

What is a Compounding Aseptic Isolator?

Essentially, a Compounding Aseptic Isolator takes the place of a cleanroom by providing cleanroom conditions within a contained workspace. The work area is accessible via sealed gloves that reach into the work area.

The interior workspace is kept under positive pressure, which guarantees product safety. This works by creating a pressurized environment that is constantly forcing air towards the outside. In the event of a break of containment, such as a tear in a glove, the positive pressure would force any air from the work area out of the leak, assuring that no outside contaminants enter the workspace. (Note: A Compounding Aseptic Isolator, when placed under negative pressure, is commonly referred to as a Glovebox.)

While the USP 797 focuses on the product protection aspect of the Compounding Aseptic Isolator, it is also notable that these units provide excellent operator protection. By isolating the work environment from the user, a Compounding Aseptic Isolator actually maintains a superior level of operator safety as compared with a typical cleanroom / LAFW configuration.

What are the advantages of choosing a Compounding Aseptic Isolator?

One of the key advantages to using a Compounding Aseptic Isolator as opposed to a cleanroom and LAFW is the removal of personnel from direct contact with the critical area. Not only does this eliminate the single largest source of contamination, but it also adds a higher level of user safety.

While it is true that the area surrounding any unit in which sterile pharmaceutical manipulations are being performed should be kept under controlled conditions compliant with USP requirements, a Compounding Aseptic Isolator offers a compromise. USP 797 mentions specifically:

"…A properly maintained barrier isolator also provides an acceptable environment. A barrier isolator provides a Class 100 environment for product preparation; therefore, the isolator itself can be in a separate area of the pharmacy but need not actually be in a cleanroom."

Many smaller hospitals as well as those housed in older buildings or allotted a small pharmacy space can benefit from a Compounding Aseptic Isolator. Compared to a cleanroom, which must incorporate a designated buffer area, a Compounding Aseptic Isolator is a small unit that will not take up much more space than a traditional laminar flow workbench. This makes the unit ideal for all facilities that are concerned about saving space.

Another consideration is that gowning up for cleanroom work as defined in USP 797 requires each worker to remove all makeup and jewelry, thoroughly scrub their hands and arms to the elbow, and don hair covers, shoe covers, gowns and facemasks. This process is estimated to take 45 minutes per worker per shift. This type of gowning is not required for work within a Compounding Aseptic Isolator.

The time saved by not having to gown and de-gown each time work is halted can be extremely beneficial, especially when an operator is required to multitask. For instance, a single employee working the night shift might be required to receive a package or answer the phone in the course of her shift. If, at that time, they were working within a cleanroom, they could lose nearly an hour simply following the designated safety procedures.

Decontamination is easier in the small, contained environment of the Compounding Aseptic Isolator; it is also reproducible. A procedure can be written which will ensure that the same decontamination process is performed every time.

What are the disadvantages of choosing a Compounding Aseptic Isolator?

The major disadvantage to the Compounding Aseptic Isolator is that it hinders the movement of the operator. While advances (such as two-part accordion gloves) have been made to help facilitate easier movement within the isolator, the fact remains that operating through gloves and within an isolated workspace is slower and more difficult than traditional methods. Workers within a cleanroom can move freely and are limited by little more than basic nitrile (or equivalent) gloves.

Compounding Aseptic Isolators, even those that incorporate laminar flow, do not protect the product from the use of bad technique. As with a cleanroom and laminar flow workbench, it is necessary to use proper technique at all times to prevent contamination. While the barrier may be protecting the product from outside contaminants, particulates and vapors created inside the work environment can still create unsafe conditions if the proper technique is not employed.

Despite the flexibility of a space-saving Compounding Aseptic Isolator, it should be noted that each time the unit is moved it must be recertified. Therefore, the isolator (or LAFW, for that matter) cannot be moved without disrupting its daily usage.

Conclusion

The revisions to USP 797 have created a stir in the world of hospital pharmacies, as was evident to anyone who attended the recent ASHP convention in Orlando. These revised regulations are FDA enforceable and all evidence points to that organization’s resolve to carry out that enforcement. Because of this, it behooves all compounding pharmacies to become compliant before they are fined.

Whether it is the decision of your hospital to install a cleanroom or opt for a Compounding Aseptic Isolator, the goal is safety. Both systems have their benefits and drawbacks but it is up to the individual pharmacy directors to make the best decision for the future of their business, their personnel and their patients.