Pharmacy Purchasing & Products: What is the best approach to properly cleaning and disinfecting a cleanroom?

Keith St. John: The best approach is to keep your cleanroom in a constant state of “readiness.” A cleanroom should never get to the point where heavy duty cleaning and disinfecting is required, and this means maintaining a daily cleaning and disinfecting routine—at the very least. It also is key to address any situation that requires cleaning and disinfecting, such as spills, when they occur. While stopping production to clean and disinfect is inconvenient, it is critical to ensuring a sterile compounding environment where microorganisms cannot multiply. To encourage responsible habits, it is helpful to institute a perpetual monitoring process involving a checklist review with feedback to gauge performance and identify areas for improvement.

It also is important to approach cleaning and disinfecting the cleanroom realistically: While policies and procedures that minimize the risk of microbial contamination should be employed, keep in mind that all viable life forms, including spores, cannot be removed from all environmental surfaces. However, the critical site must be kept sterile at all times.

PP&P: What are some common challenges involved in cleaning and disinfection practices?

KSJ: Misuse of chemicals is a common problem. In order to help avoid this, it is critical that all cleanroom staff be aware of the characteristics (e.g., photosensitivity, respiratory irritant, incompatibility with certain materials) of the chemicals being used. Improper dilution of chemicals is another common mistake, and it is one that can be easily avoided by following the manufacturer’s guidelines. For example, the requisite contact time for disinfectant agents on environmental surfaces must be followed using the manufacturer’s guidelines in order to maximize the effectiveness of the chemical agent.

There also is confusion in regard to the circumstances under which certain chemicals should be used. For example, disinfectants, such as sodium hypochlorite (in a one to ten dilution without any detergent additives) or 70% isopropyl alcohol, sometimes are used as cleaning agents. Neither of these chemicals are good cleaning agents, but they are effective as disinfectants once the surface is cleaned of any residual material. If the goal is to use a single product for cleaning and disinfection, make sure the chemical agent has a stated efficacy for such purpose by the manufacturer.

The bottom line in avoiding the misuse of chemicals, is that it is critical to understand the properties of the products you are using and have a clear understanding as to why you are using them. With proper education and training, these common mistakes can be avoided.

PP&P: How does USP Chapter address the use of cleaning and disinfection products?

KSJ: While the chapter requires that you clean the different surfaces in the cleanroom, specific products and the protocol in which to employ these chemicals are not detailed in the chapter. Rather, the chapter includes a selection table in Appendix II outlining the pros and cons of the various germicides and chemical agents.

PP&P: What are some points of consideration when choosing a germicidal detergent?

KSJ: There are many germicidal detergents available on the market and it is important to understand that there are pros and cons to each product. When deciding which germicidal detergent to use, some points to consider are the chemical’s microbial activity profile, compatibility with the surfaces that are to be cleaned, and how it will react with other chemicals that are used in the cleanroom.

Typically, the standard in the industry has been to use either phenolics or quaternary ammonium compounds for floors and walls (i.e., low-touch surfaces). There are new formulations of stabilized sodium hypochlorite solution (i.e., bleach) that include detergent additives, and recently there has been increased interest in using accelerated hydrogen peroxide germicides, which have a very low flammability profile, toxicity, and residue factor. While this is a great product for use in a cleanroom environment, it is typically more expensive than other germicidal detergents. A pharmacist always needs to evaluate the cost/benefit issues, but for certain surfaces, particularly preparation tables and ISO Class 5 hoods, it may be worth the extra investment because of its low toxicity and low residue factor along with its enhanced cleaning and disinfection properties compared to 70% isopropyl alcohol.

PP&P: When is sterile alcohol required?

KSJ: Sterile alcohol is required for disinfecting a “critical site.” This is defined by USP Chapter as a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampoules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination.

PP&P: When is the use of isopropyl alcohol appropriate?

KSJ: Given the additional cost of sterile alcohol, you will want to use non-sterile 70% isopropyl alcohol when it is appropriate. As a water-based product, isopropyl alcohol should be used to disinfect surfaces when the goal is to achieve zero residue, in other words, any surface where sterile IV medications are compounded. While these areas are characteristically clean to begin with, you must pre-clean these surfaces before disinfecting with 70% IPA.

PP&P: When is it not appropriate to use isopropyl alcohol?

KSJ: Isopropyl alcohol should not be used when the goal is to both clean and disinfect a surface. For example, items removed from shipping boxes should be cleaned and disinfected, so the use of isopropyl alcohol alone is insufficient since it is only a disinfectant agent.

There have been scenarios where isopropyl alcohol was being used to disinfect floors in the cleanroom of the pharmacy. Not only will the isopropyl alcohol not clean the floors, it will create a high-risk flammability hazard. Only germicidal detergents should be used to clean and disinfect floors and other low/no-touch environmental surfaces.

PP&P: How should cleaning and disinfecting processes be monitored?

KSJ: I am intrigued by a low-tech approach that recently came into the market and provides real-time quality assurance monitoring for the cleanliness of environmental surfaces. Ecolab’s EnCompass Environmental Hygiene is an example of such a program and includes a fluorescent gel testing solution (the DAZO Monitoring System) that glows under black light, but is invisible to the naked eye, and is used to identify surfaces that have not been cleaned properly. Studies monitoring the state of cleanliness in a critical care environment have shown that this product has identified areas that appeared clean, but in fact, were not. While these products are currently being marketed for use in critical care environments, it could be a great tool to use in the pharmacy to monitor whether policies and procedures for cleaning and disinfection are being followed.

Using environmental microbial culturing of the cleanroom we get a retrospective view of the state of cleanliness. This new solution, however, allows for environmental cleanliness and disinfection to be assessed in real time, and it is important for pharmacy to implement real-time quality assurance assessments in the cleanroom to minimize the risk of delivering a contaminated preparation to a patient.

Keith H. St. John, MS, CIC, has been an infection preventionist for over 25 years in a variety of hospital settings. He is certified in Infection Control & Epidemiology and has served as a past president of the Certification Board of Infection Control & Epidemiology (CBIC). Keith has served as Delaware Valley-Philadelphia APIC Chapter President, a member of the APIC Governmental Affairs Committee, APIC Text Revision Task Force and chapter author, APIC Education Committee, APIC Practice Guidance Council, and is a past member of the Editorial Board for the American Journal of Infection Control. In addition to his involvement with APIC, Keith is also a member of The Society for Healthcare Epidemiology of America (SHEA), The Hospital Infection Society (UK), and is presently an expert member of the USP Sterile Compounding Committee. Keith specializes in the effective management of infection prevention and control activities using technology and other means to achieve improved patient outcomes. He is currently employed as an Infection Prevention Consultant with BD Diagnostics, Informatics Division, based in Austin, Texas.

Disclosure: Keith H. St. John has nothing to disclose.