First of all, what is a “cleanroom”?
Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, depending on the industry in which it is used. A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters. Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body. Sterile compounding technicians must master aseptic technique before being able to compound sterile medications. All medications are prepared in an ISO 7 Classification air quality (meaning there can be no more than 352,000 particles every 35.2ft3), also called an Ante Room. All ingredients are aseptically manipulated in an ISO 5 Classification (no more than 3,520 particles every 35.2ft3), also called a Buffer Room. This is made possible by controlled air change. A critical factor in cleanroom design is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classification and usage, air change occurs anywhere from 10 to more than 600 times an hour.
Sterile compounding personnel follow guidelines that have been set in place by USP. USP stands for United States Pharmacopeia, a legally recognized compendium of standards for drugs, published by the United States Pharmacopeial Convention, Inc., and revised periodically; it also includes assays and tests for determination of strength, quality, and purity. USP 797 is the chapter in which all sterile regulations are outlined. This is very important in sterile compounding because this is the information we refer to when doing anything associated with sterility.
One of the guidelines is the technicians and pharmacists must master aseptic technique and manipulations. They must be trained conscientiously and skillfully by expert personnel and through audio/video instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations and in maintaining ISO Class 5 environmental conditions. This is tested semi-annually by a hands on test mimicking our most difficult CSP (compounded sterile preparation). Below are some pictures showing our lab and our cleanroom.