By Jeannie Bennett, RPh, MS, and Firouzan “Fred” Massoomi, PharmD, FASHP
MAINTAINING THE INTEGRITY OF THE CLEANROOM ENVIRONMENT POSES significant and continuous challenges, partially due to the two main sources of particulate contamination that can compromise the air quality: personnel and products used for compounding. To maintain the cleanroom as outlined in USP Chapter <797>, sterile compounding managers should develop set procedures to minimize entry of particulate matter. These procedures must include the establishment of a formal cleaning schedule.
A Formalized Cleaning Strategy
A formalized cleaning plan and schedule for sterile compounding areas is essential to continually minimize air particulate contaminations. All areas within the anteroom and compounding area need to be addressed and can be placed on a daily, weekly, or monthly cleaning schedule, based upon the room and surface area.
Nebraska Methodist Hospital (NMH) is a 440-licensed bed, not-for-profit facility located in Omaha, Nebraska. In 2006, the department of pharmacy services compounded 325,029 lowand medium-risk sterile products, in addition to 2,107 sterile hazardous drugs. NMH has a formal sterile compounding area with a 500-square-foot anteroom, a 400-square-foot ISO Class 7 cleanroom, and another 120-square-foot ISO Class 7 cleanroom designated for hazardous drug compounding.
Our pharmacy staff documents the completion of each task on a form to be monitored by the sterile compounding manager. A separate form is used for each area. At NMH, three certified pharmacy technicians are assigned to clean one room each. To minimize cleaning time, anteroom inventory is limited to a four-day supply and wire shelves are utilized. The cleanroom can take two hours to clean, and the anteroom takes one to two hours to clean in two separate sessions. We divided our anteroom into two separate areas for cleaning to minimize the disruption to workflow. The hazardous drug room has minimal inventory and takes about an hour to clean. During the cleaning process outdates are also checked. The floors are cleaned by the housekeeping staff each evening.
All of our cleanroom cleansers have been approved by NMH’s epidemiology department to ensure that they meet the requirements for high-level disinfection.
Counter tops, shelving, and storage bin surfaces are cleaned using PDI Super Sani-Cloth germicidal disposable wipes. We cleanse the carts used in the transfer of products and the outer surface areas of our laminar flow hoods with a high level disinfectant, STERIS LpH-Se. Personnel don gloves to protect themselves from exposure to these agents. It is important to note that these disinfectants destroy all microorganisms with the exception of highly concentrated bacterial spores. We disinfect our anteroom sinks daily with LpH-Se. Outside of established cleaning times, NMH’s housekeeping personnel are not allowed to enter the cleanroom. Pharmacy staff moves all rubbish from the cleanroom to the anteroom twice daily. All sharps are disposed of in red biohazard sharps containers. Hazardous waste is disposed of in yellow or black containers, based upon regulated waste streams. These containers are managed by housekeeping once they are filled and sealed by pharmacy personnel.
Cleaning the Cleanroom
The NMH cleanroom is cleaned by surgical services housekeeping personnel. The vents and floors are cleaned on a daily basis, and on a monthly basis, the room is “term-cleaned,” to ensure that a clean environment is created and maintained to the same standard as the NMH surgical suites.
For daily cleaning, the cleanroom floors and vents are cleaned using STERIS Coverage Concentrate made according to manufacturer’s specifications. A department-dedicated bucket is used to prevent contamination from other areas of the hospital. Prior to entering the cleanroom, housekeeping personnel don appropriate garb. The vents are first wiped with a clean cloth. Then the floor is cleaned, starting from the farthest corner of the room and proceeding to the entry room door.
For the term cleaning of the cleanroom, pharmacy personnel ensure that compounding of all sterile products is completed for the day. The rooms are then cleaned in the following order:
Self-Validation of Air Quality
Once a cleaning schedule is developed and initiated, an environmental monitoring program must be established to ensure the following processes are being followed according to procedure:
NMH uses the Graseby In-line Suction System by Andersen to collect air samples as part of our environmental monitoring program. A grid was drafted of the cleanroom to ensure that samples were included from all high-traffic areas and areas of expected contamination. An inhibitive mold agar Petri dish (for molds/fungus) and a blood agar Petri dish (for bacteria) are labeled with the room, location, and date, placed into a biohazard bag and hand delivered to the microbiology department for incubation. The plates are incubated for four days and any growth is cultured and identified.
In addition to self-validation, NMH utilizes CSI Testing Inc. of Plymouth, Minnesota, for semi-annual air testing, laminar flow hood certification, and pressure gradient measurements. Reports are compared and monitored for any trends of increased particulates. If increased particulate levels are observed, the sterile compounding staff evaluates the procedures used in that specific area to identify potential sources of contamination.
By following the cleaning procedures outlined above, NMH is able to maintain a compounding environment that complies with the standards set forth in USP Chapter <797>. Establishing a cleanroom cleaning program can be made easier by breaking things into smaller tasks. Begin by looking at your daily processes. Determine if inventory can be minimized, and reduce traffic into the room. Your department of epidemiology can be very useful in helping you determine the correct cleaners and disinfectants to use in your cleanroom, and your surgical services housekeeping department can help you determine schedules, products, and techniques for cleaning your room. Contact your environmental services department to test your HEPA filters and airflow. After implementing your cleaning program, compare before and after air samples to see if your cleaning methods have improved your air quality. Most of all, involve your employees. Have them read USP Chapter <797> and understand the importance of the changes you are trying to establish. They may bring a fresh perspective to the table and come up with some great ideas.
Jeannie Bennett, RPh, MS, is a patient care pharmacist at Nebraska Methodist Hospital in Omaha, Nebraska, where she has worked for the past eight years.
Fred Massoomi, PharmD, FASHP, has served as the pharmacy operations coordinator at the Nebraska Methodist Hospital for the past 11 years.
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