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Understanding Cleanrooms Answers to Frequently Asked Questions By Pat Hynes, VP of Global Quality, Baxa Corporation |
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INTRODUCTION The USP General Chapter <797> on compounding sterile preparations makes some specific recommendations regarding cleanliness and cleanrooms. While it does not specifically require a cleanroom for sterile compounding, the guideline does require that sterile compounding take place in a separate area that meets a defined level of cleanliness. Many pharmacists have expressed concern about cleanrooms and their requirements in an attempt to clarify the requirements for USP 797 compliance. The discussion below is intended to provide a general understanding of what cleanrooms are and how they are monitored. WHAT IS A CLEANROOM? ISO 14644, the international recognized cleanroom standard defines it as, “a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particulates inside the room, and in which other relevant parameters, e.g., temperature, humidity, pressure, are controlled as necessary.” Control in this context means that a selected parameter is governed by procedure and practice, is routinely measured, and prescribed action taken if that parameter exceeds predetermined limits. WHAT IS A CLEAN ZONE? "A dedicated space in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in which other relevant parameters, e.g., temperature, humidity, pressure, are controlled as necessary." See ISO 14644. HOW ARE CLEANROOMS AND CLEAN ZONES CLASSIFIED? There are nine classes of cleanrooms specified in ISO 14644. These classifications are based upon particle counts within one cubic meter of room air. ISO Class 1 is the highest or cleanest rating. ISO Class 9 is the lowest possible rating. In a hospital pharmacy context, USP <797> requires the maintenance of ISO Class 5 air quality. Below are the particle count requirements for ISO Class 5*: Particle size -- Maximum number of particles allowed 0.1 µm -- 100,000 0.2 µm -- 23,700 0.3 µm -- 10,200 0.5 µm -- 3,520 1 µm -- 832 5 µm -- 29 *Under Mil Standard 209-E, this is a class 100 area HOW ARE PARTICLES COUNTED? Particle counts can be accomplished using air and surface test kits that are collected and sent for verification, or through automated particle counters. Firms that do the certification for laminar flow hoods and biological safety cabinets often have this capability as well. A number of firms provide environmental monitoring services. There are also a variety of equipment options. For background on particle counting, see http://www.particle.com/whitepapers_met/iaq.htm WHY ARE PARTICLES A PROBLEM? Airborne particles provide a ride for microorganisms, as well as food and surface area on which to reproduce. Outside of the microbial load, particulate that makes its way into IV solutions presents a challenge to the patient’s organs and vascular system. Particulate undetectable by visual inspection can cause phlebitis or iatrogenic disease. People are the biggest contributors of particulate contamination. WHAT SORT OF MONITORING IS USUALLY DONE IN CLEANROOMS? Typically, airborne particles, airborne viables, surface viables, pressure, and temperature are all monitored. The risk level of the compounded sterile product (CSP), the nature of the room, its history, people load, and other variables need to be taken into account when establishing the monitoring frequency. DO I NEED PROCEDURES FOR A CLEANROOM? Yes, typically you would find the following procedures helpful in an effective cleanroom program: Cleanroom definition or specification document. This describes the room, how it will be used and why it is adequate for the intended use. Cleanroom monitoring procedure. This indicates how and when you will perform environmental monitoring and includes a record of your monitoring activities. Cleanroom alert and action limits should be established, as well as what to do in the event of a power outage or other shutdown. An annual re-certification must be performed and documented. HOW IS CLEANROOM AIR FILTRATION ACCOMPLISHED? There are two common filtration methods. Both employ HEPA filters. Fan Powered HEPA Filtration uses motorized ceiling-mounted units that filter the air. The units fit neatly into an existing acoustic ceiling grid. This method does not pressurize the room and is the more inexpensive approach. Alternately, banks of HEPA filters can be mounted in air-handling units outside of the cleanroom. Filtered air is pumped to the cleanroom and then returned and circulated through the filter banks. This method typically provides overpressurization of the room. WHERE CAN I FIND OUT MORE? For more information, visit the Baxa Web site, http://www.baxa.com/OnlineHelp and download the Cleanroom FAQs, or review the references cited below. This article provides an overview of cleanroom issues. Pat Hynes, VP of Global Quality, is available to answer your specific questions regarding pharmacy cleanrooms and USP 797 compliance. Contact him at pat.hynes@baxa.com. References: 1 Control of Particulate Contamination in Healthcare Manufacturing, Barber, Thomas A., Interpharm Press, ISBN 1-57491-072-8 2 HEPA Corporation, http://www.hepa.com/. 3 ISO 14644 Cleanroom Standards (4 documents) 4 Cleanroom Design, Whyte, W., ISBN 0471 942049. ©2004 Baxa Corporation |
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Cleanroom entry procedure. The "rules" for authorized entry, gowning, hair covering, hand washing, what materials are and are not allowed. |
Cleanroom housekeeping procedure. The guidelines for how you clean, approved cleaning agents, the frequency for cleaning, and a record of when it has been done. |
ABOUT THE AUTHOR J. Patrick Hynes, Vice President of Global Quality for Baxa Corporation, has more than 20 year’s experience in quality assurance and regulatory affairs activities. At Baxa Corporation, he has been involved in critical strategic initiatives for adopting lean manufacturing processes and Six Sigma implementation. He is a recognized expert in cleanroom design and requirements both through his work at Baxa Corporation and with COBE Cardiovascular worldwide. Pat’s previous employment includes positions in new product development, manufacturing management and product evaluation. He was instrumental in the development of Baxa Corporation’s current quality system and is responsible for the enforcement of Quality System Requirements (QSRs). Pat holds a BS in Biology with a minor in Chemistry. |
ABOUT BAXA CORPORATION As a leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom; Denmark, and Germany; and distribution partners worldwide. |