10 Things to Know to Fast Track to USP797 compliance

In the past, compliance with guidelines for sterile pharmaceutical compounding was a mandated responsibility for large-scale pharmaceutical manufacturers and a voluntary responsibility for smaller-scale hospital and retail pharmacies that compound sterile preparations. But with a steady onset of concerns over the years for patient safety and the proliferation of guidelines that followed, USP Chapter 797 was finally enacted January 1, 2004 and represents the first enforceable standards for sterile compounding in all areas where sterile compounding takes place. With the onset of such sweeping changes, naturally comes a period of confusion, misinterpretation, and sometimes even fear. Now that the 4 year honeymoon period has expired as of January 1, 2008, and we are fully one year in to the new mandate, there is increasing urgency to get up to speed and compliant with USP 797. In an effort to simplify some of the basics of the 18 page, single space document outlining the provisions of the new chapter, here are 10 simple things you need to know to fast-track your pharmacy into creating a USP797 compliant environment..

1. USP 797 does not require construction of a sophisticated cleanroom, but sterile mixing must take place within an ISO Class 5 laminar hood which is in a clean room ISO Class 8 or lower. A Positive pressure air system with Hepa filtration and proper garmenting will help you lower particle threshold to below 10,000 particles per cubic foot.
2. People are the single greatest source of contamination in the cleanroom. The average person sheds approximately 200 particles per minute performing normal activities. 10% of these particles are bacteria or other microorganisms. Therefore, proper garmenting to create an effective barrier is essential. This means high particulating cotton lab coats are out and low-particulating polyester reusable garments or microporous disposable garments are in. The greater the coverage of barrier between body and product, the cleaner the product will be.
3. All environmental surfaces must be kept free of particulate and microbes. Airborne particulation must be suppressed. This means high-linting cotton gauze is out and low-linting polyester and non-woven wipers are in. Proper technique when wiping is critical. A one-pass approach with a quarter-folded wiper is recommended. This gives each wiper an 8-pass life with each folded surface making contact with the work surface just once. Pre-saturated wipes with chemistries consistent with your pharmacy's protocol can further help simplify and standardize your processes.
4. A gowning protocol should be established and clearly visible to anyone who will be gowning. A change into fresh garments and donning new gloves, mask, beard cover , shoecovers and other accessory apparel should occur prior to EACH entry into the mixing area and each item should be donned in a particular order in accordance with methods known to suppress particulation and contamination.
5. Adhesive tacky mats should be placed at all entry points into the Cleanroom area. Tacky mats remove excess particulate from shoes and shoecovers. A new layer should be peeled back at regular intervals consistent with traffic flow. A water-based adhesive mat is advisable as it provides superior adhesion of particles and does not out-gas the toluene solvent in toluene-based adhesives.
6. Cardboard boxes, paper, and other linting items should be kept in a staging area outside of the cleanroom. Special Cleanroom printer paper and other cleanroom papers such as spiral-bound notebooks should be used if paper is required in the cleanroom.
7. Cleaning of the asceptic and support areas must also be maintained in a manner that contributes particle and microbial suppression as well. This means that mopping and wiping procedures of surfaces such as floors, walls, equipment, and work apparatus must also be performed in such ways to minimize or eliminate bioburden and not contribute particulation from the cleaning materials themselves. Cotton mops need to be replaced by single-use or launderable polyester or other synthetic non-linting heads.
8. Environmental monitoring of air and surfaces for microbial and particulate matter is required to ensure the threshold of particles is kept within limits. The environmental monitoring program is used to spot failures and track trends so that remedy measures can be identified.
9. In addition to sterile compounding areas, USP 797 also addresses packaging, handling, transportation and storage of sterile, cytotoxic and hazardous compounds after leaving the pharmacy. The administration of IV drugs is not covered in USP 797 but it is important to note that procedures such as beyond-use dating and proper labeling remains a critical responsibility.
10. USP 797 contains written requirements for Quality Control, storage of ingredients, asceptic techniques, housekeeping care, and education of patients and staff. Excerpts covering these various areas should be made available to the support staff so that USP 797 compliance can be seamless and its mission to improve patient safety can be well understood by all.