USP 797 Compliant Cleanrooms
- Lasco's USP 797 compliant clean room.
- Case Study >> USP797 Clean Room
Hopkins County Memorial Hospital a rural hospital leading the way in transforming their cleanrooms into USP 797 compliant cleanrooms. Lasco Services was able to install a seamless floor, laminate all the walls, install ante-room separation walls and doors, re-work the HVAC supply and furnish the HEPA filtration all within a tight time-frame and without hampering the pharmacy's operations. read more
More Interesting USP 797 Links
Questions on USP 797
Questions and Answers on USP Chapter 797 with Clyde Buchanan
ASHP Compounding Resource Center
American Society of Health System Pharmacists Frequently asked questions on everything on many “gray” areas of USP 797 are answered by Clyde Buchanan, MS, FASHP is Senior Director of Pharmaceutical Services for Emory Healthcare.
General Information on USP 797
ASHP’s Compounding Resource Center
A web site resource of the American Society of Health System Pharmacists. A great variety of resources for compounding needs & questions.
“The ASHP Discussion Guide for Compounding Sterile Preparations – Summary and Implementation of USP Chapter <797>”
Developed by ASHP and Baxter Healthcare Corporation Medication Delivery A PDF document of 12 pages covering USP 797.
Pharmacy Purchasing & Products Magazine
“is the product information source for health-system pharmacy purchasing stakeholders. Pharmacy Purchasing & Products features an editorial mix of news and reviews, covering the latest in product news relating to USP-797 & NIOSH guidelines…”
What is happening in some small hospitals
Rural, Small Hospitals Face JCAHO Challenges
Written by Donna Young
An article from ASHP News in their Small and Rural Hospital Resource Center from the ASHP web site: http://www.ashp.org/srh/
JCAHO requirements for small hospitals are difficult, according to some interviewed in this article. Space for cleanrooms is discussed. Other issues are mentioned.
USP US Pharmacopeia Web Site
Purchase USP Pharmacists’ Pharmacopeia
Why a Pharmaceutical Cleanroom?
USP 797 on pharmaceutical compounding is unclear. Its requirements on low, medium and high risk compounding cause varied interpretation, if not downright consternation. And, it is still under revision. Proposed updates for commentary should appear in the March-April 2006 issue of Pharmacopeial Forum, the USP journal.(1)
One thing is clear: new air quality requirements for compounding. The traditional critical air environment of ISO Class 5, must now be surrounded by a positive pressure buffer room of ISO Class 7.(2, 3) The buffer room is required if the critical area is in a Laminar Airflow Workbench (LAFW); it is recommended if the critical area is within a Barrier Isolator.(2)
Pharmacists also are being asked to implement and improve the air environment surrounding the production of hazardous drugs.
Hazardous drug compounding should be done in a biological safety cabinet, vented 100 percent to the outside, according to The National Institute for Occupational Safety and Health (NIOSH), in September 2004.(4)
The cabinet should be in a negative pressure cleanroom, as recommended in a December symposium sponsored by the American Society of Health System Pharmacists (ASHP).(5) A USP subcommittee on 797 is "working on statements" concerning the air flow and the pressure of the cabinets' location. Those proposals may also be published in the April revisions.
A cleanroom is the best way to create the buffer room. It consists of smooth, impervious floor, walls and ceiling with proper vents and doors, to support the heart of a cleanroom, the HVAC with HEPA filters, which controls the air pressure, creating the ISO Class 7 during operation. It also maintains the desired temperature and humidity. The HVAC basically operates itself, making the room a clean, simple, and thus employee friendly way to be compliant and produce safe product.
Consider possible layouts of the "Cleanroom Complex" as one ASHP panel expert describes it.(5) The ante-room, or gowning room, can open to two positive pressure rooms, with one for low to medium risk compounding and the other for high-risk; or a positive pressure room for all three levels; or a positive pressure and a negative pressure room; or just one positive pressure room. Rooms connect only through hands-free doors or strip curtains, and if needed, pass through cabinets for product.
This set-up insures that air flow and pressure is ALWAYS maintained in the buffer room to provide as clean an environment as possible. As one Texas pharmacist put aptly, "an atmosphere with the least amount of chance of a problem."(6)
Not only is the atmosphere as safe as possible, it can be argued that the cleanroom complex promotes good aseptic procedure.
Simply having to enter a special area, don special garb, and pass through another door into an environment containing only the needed equipment, promotes the mindset that special and proper procedures are routine in the space. Documented and non-documented are observed and self-caught lapses in good technique or practice; the cleanroom complex fosters attention to standard practices. A technician's work quality and productivity is enhanced, not hurt, by putting the traditional Laminar Airflow Workbench (LAFW) into a cleanroom.
With its temperature and humidity controls, its professionally designed HEPA filtering and HVAC specific to the critical area location, and its modular construction, the cleanroom provides the safest, most durable and viable compounding atmosphere, particularly as one looks years ahead. Future compliance requirements, increase in space needs due to growth in amount of compounding, or to change to physical space is all easily accommodated through the modular construction. Cleanrooms provide a clean environment for using any equipment, benches, or cabinets.
Please contact us or fill out our USP 797 Cleanroom Worksheet for help with your cleanroom. We will work with you to build into your existing space or create a new space, and take advantage of every possible feature, while adeptly handling any unique circumstance.
Explore this Web site for information gleaned from and excerpted from professional organizations and from our clients, as well as click on links to take you directly to the source.
1. American Society of Health System Pharmacists Compounding Resource Center Web Site. "Revisions Continue on USP Sterile-Compounding Chapter", Cheryl Thompson, AJHP News, Sept. 15, 2005
2. USP Pharmacists' Pharmacopeia, 2005 First Edition, pg. 418
3. USP US Pharmacopeia "Proposed Revisions to USP Chapter 797 Pharmaceutical Compounding - Sterile Preparations", compiled by Dr. David W. Newton
4. Centers for Disease Control and Prevention Web Site NIOSH Alert "Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings"
5. American Society of Health System Pharmacists Compounding Resource Center Web Site. "USP Chapter 797 Standards: An Expert Panel Offers Practical Strategies for Implementation", E. Clyde Buchanan, M.S., FASHP, Eric S. Kastango, M.B.A., R.Ph., FASHP, Darryl S. Rich, Pharm.D., M.B.A., FASHP
6. Lasco Services Web Site "Case Study Hopkins County Memorial Hospital", by Leslie Gibson, Feb. 2006