Infection Control in the Cleanroom

January 2012 - Vol. 9 No. 1 - Page #2

Q&A with Sue Barnes, RN, BSN, CIC,
National Infection Prevention Leader

Pharmacy Purchasing & Products: What infection prevention and control concepts are key for compounding staff to understand?
Sue Barnes: The Association for Professionals in Infection Control and Epidemiology (APIC) position paper on safe injection, infusion, and medication vial practices in health care1 should be required reading for all staff involved in compounding. This practice guideline addresses five key compounding concepts:

  • Compounded sterile preparations (CSPs) should be prepared in the cleanroom, according to USP <797> requirements for ISO Class 5 cleanroom environments, as well as non-ISO environments where CSPs are prepared for immediate use (within one hour of preparation).
  • The one-hour limit defined for immediate use is expected to preclude microbial population increase when accidental contamination of such drugs occurs. Once microbial contamination occurs, the organism replication can begin within one to four hours, with exponential growth occurring rapidly thereafter.
  • Compounding in an ISO Class 5 environment requires aseptic technique in addition to environmental controls including stringent air quality, ventilation, personal protective equipment (PPE), and personnel and surface sanitation requirements. These measures ensure the sterility of the preparation and the safety of compounding personnel.
  • Non-cleanroom immediate use areas, such as infusion clinics, ORs, pre-op, and any location where CSPs are prepared are subject to requirements for aseptic technique, but not requirements for environmental controls and strict PPE usage.
  • Aseptic technique for CSPs, whether in a cleanroom or not, is guided by key principles, including proper hand hygiene using alcohol-based degermer or soap and water prior to preparing and administering CSPs; use of a new sterile needle and a new sterile syringe for every access; removing all access devices from the vial; storing the vial in a clean, protected location according to the manufacturer’s directions (eg, at room temperature or refrigerated); ensuring that any vial whose sterility may be comprised is immediately discarded; disinfecting the hub of the vial prior to withdrawing medication; and disinfecting the hub of the IV tubing or bag into which the medication is being added.

PP&P: How does APIC address the controversy surrounding the preparation of immediate-use CSPs?
Barnes: There is significant risk for contamination of medications prepared outside of an ISO Class 5 setting given the microorganisms and particulates that exist in the environment. For example, it is common for a clinician preparing an injection for immediate use to perform hand hygiene, but not wear sterile gloves, a mask, or contain their hair. Thus, if the cap is removed from the needle and inserted into the vial while the clinician is breathing over the sterile needle and vial stopper, the potential for microbial contamination is created. Likewise, spiking an IV bag with a one-way device and leaving it in place increases microbial contamination risk. The spike collects contamination from the environment, which can be transferred to the sterile solution when it is withdrawn. Spiking a solution with a one-way device that is left in place for multiple entries is strongly discouraged.

There also are significant costs associated with immediate-use CSPs that should be considered. Once a preparation is completed (eg, spiking an IV bag), USP <797> requires administration of the immediate-use CSP to begin within one hour. The cost of disposing of products that fall outside the one-hour window can be daunting. To prolong the usability of these CSPs and ensure product safety, USP <797> recommends all needed injectables and infusions be prepared in the pharmacy’s ISO Class 5 environment by trained, garbed staff. For CSPs classified as low risk, the room temperature beyond-use date is 48 hours; after this point, the CSP must be discarded if not used. Another possibility is using a manufacturer’s prepackaged medication, which should be discarded according to the manufacturer’s expiration date.

In practice, however, many clinicians prepare IV drugs in ORs and in patient care units in advance of use to improve workflow and productivity. This advance preparation often occurs at set times on the morning of or the evening prior to their intended use. While the one-hour window from preparation to start of administration is often problematic to comply with in actual practice, APIC does not support advance preparation of immediate-use products, as it is clear that parenteral medications are safest when prepared as close as possible to the time of intended administration.1 When immediate-use preparation is necessary, proper technique is vital to preventing unintended contamination during the compounding process. As such, only trained staff should be allowed to prepare parenteral medications and that training should include tactile learning methods, competency verification, and periodic monitoring to ensure compliance with aseptic technique. Preparation must be performed in a clean, dry workspace, void of clutter and obvious contamination sources (eg, sinks). Furthermore, prepared parenteral solutions should be stored in a secure environment to limit the risk of tampering.

PP&P: What should the Infection Preventionist’s (IP) role be in the development of cleanroom cleaning P&Ps?
Barnes: The relationship between IP and pharmacy should be consultative in nature. IPs might denote pharmacy as a high-risk unit that they personally visit. While pharmacy staff should work with their professional organizations (eg, American Association of Colleges of Pharmacy and ASHP) to obtain education and training regarding compliance with USP <797> requirements, they also should call IPs with questions regarding contamination risk as needed. In addition, IP departments should be involved in endorsement/consultation when environmental cleaning and disinfection policies are developed for high-risk areas, whether that process is driven by pharmacy or environmental services. The key to environmental hygiene is ensuring that cleaning is conducted with sufficient friction in order for the next step, disinfection, to be effective.

PP&P: What is the importance of environmental sampling in ensuring continuous cleanliness in the compounding environment?
Barnes: According to published guidelines from APIC and the CDC, routine environmental culturing is not recommended except in the event of an outbreak. In contrast, environmental culturing is required by USP <797>. There are other tools in addition to culturing that can be used to monitor the quality of environmental cleaning. These include glow test products and ATP testing kits. A number of glow testing products are available, and these typically include a clear fluid that fluoresces under black light. The glow test product can be applied to high-touch surfaces, and using a black light after the area is routinely cleaned will indicate if the clear fluid has been completely eliminated during the cleaning process. If insufficient friction has been applied to surfaces during cleaning, residual fluid will appear under the black light, indicating that the cleaning methods require improvement.

Another tool used to monitor environmental cleaning is the ATP swab test, which tests for the presence of adenosine triphosphate, an organic compound found in the cells of all plants and animals, including bacteria, viruses, and fungi. To perform ATP testing, a dry swab is swiped over the cleaned surfaces and then placed into a meter. The meter determines the presence of ATP on the swab, providing readings in relative light units (RLUs). The detection of ATP indicates the presence of contamination. With both the ATP and glow test, the results are clear almost immediately. Either or both of these tools can be used to test the cleanliness of a cleanroom.


  1. Dolan SA, Felizardo G, Barnes S, et al. APIC position paper: Safe injection, infusion, and medication vial practices in health care. Am J Infect Control. 2010;38:167-172.

Sue Barnes, RN, BSN, CIC, National Infection Prevention Leader, is the national program leader for infection prevention for Kaiser Permanente. Based in Oakland, California, she is responsible for eight regions, 35 hospitals, and 431 medical offices. Sue has been at Kaiser Permanente for over 20 years and is one of the authors of the APIC position paper: Safe infection, infusion, and medication vial practices in health care.

For further details regarding interpretation of the USP <797> standard in relation to infection control, contact APIC to request the FAQs APIC developed in conjunction with the USP <797> Sterile Compounding Expert Committee.
APIC can be reached at or 202-789-1890.





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