ESTABLISHING SOUND PRACTICES FOR CLEANING YOUR PHARMACY’S controlled environments – cleanrooms, anterooms, controlled aseptic isolators, biological safety cabinets, and hoods – can be an important and cost-effective step towards lowering the risk of contamination in your compounded sterile products (CSPs). Consistent and effective cleaning can lead to the overall minimization of bioburden in your compounding facilities and your preparations.

Isopropyl alcohol is a widely used cleaning agent, but 3% hydrogen peroxide and 2% sodium hypochlorite (bleach) solutions are also effective as sanitizing agents. However, although it is an effective disinfectant and sterilant, bleach is not a detergent capable of soil removal. A cost-effective option is to use a 2% bleach solution six days a week and a detergent disinfectant one day per week, alternating the day of the week to include weekly and monthly cleanings. In addition, cleaning agents should be rotated to prevent the development of resistant microflora. Lint-free wipes, either dry or pre-moistened with cleaning/sanitizing agents, can be used to clean isolators, workbenches, and hoods, as well as cleanroom furniture, storage bins, door handles, and molding, and to wipe products down before they enter the controlled environment. Cleanroom and anteroom ceilings, walls, and floors can be cleaned using specialized mop handles, heads, and covers.

To prevent cross-contamination, cleaning should occur from the cleanest to the dirtiest areas. Furthermore, cleaning equipment such as buckets, mop handles, heads, and covers must be dedicated to the area in which they are used. For example, equipment used to clean walls should not be used to clean floors. Furthermore, equipment used to clean an ISO Class 6 or 7 area should not be used to clean an ISO Class 8 area.

For a comprehensive guide to developing a cleaning program for your compounding areas, as well as a sample cleaning log, visit
www.pppmag.com/documents/V2N5/v2n5pp16_cleancleanroom2.pdf
to read Kate Douglass’ article on the subject.

In order to give PP&P’s readers insight into in-the-field cleaning practices, the following pharmacists offered their cleaning products “shopping lists.” There are a myriad of products you can use to meet USP <797>’s cleaning requirements. To ensure that your cleaning program is effective, monitor your controlled environments’ air and surfaces using media that promotes microbiological growth. If your colony counts exceed your established action limits, your cleaning products and procedures may be the cause, and should be thoughtfully reevaluated.

Ileana Sotto, PharmD, Clinical Pharmacy Specialist for Hematology and Oncology at Miami Children’s Hospital, uses Surface Safe from Super Gen to clean the hospital’s six laminar air flow hoods and sanitizes them with isopropyl alcohol.

Allison Hoff, RPh, Pharmacy Supervisor at CVPH Medical Center in Plattsburgh, New York, uses a variety of products to clean the facility’s controlled aseptic isolator, two biological safety cabinets, and four laminar airflow workstations. Spartan Chemical Company’s Clean by Proxy (Hdql10) is CVPH’s cleaning agent, and Metrex’s isopropyl alcohol Caviwipes are used for sanitizing. The pharmacy also uses ITW Texwipe’s Mini AlphaMop and Kendall’s ChemoSorb wipes to clean their compounding areas and equipment.

Neil Barrington, PharmD, MBA, Clinical Coordinator at the Cancer Treatment Center of America, Southwestern Regional Medical Center, uses Dispatch from Caltech as a sanitizing agent.