Investing in a new cleanroom to achieve USP Chapter compliance is generally a substantial financial and time commitment that often presents a number of workflow and logistical challenges along the way. Once such an intensive project is completed, the effort required to maintain compliance may seem pedestrian. However, meeting the requirements put forth in the chapter goes beyond just creating a proper cleanroom; it also means implementing a robust cleaning and disinfection program after the project is completed to ensure continued compliance.
To design pharmacy cleanrooms to meet specifications for HEPA filtration, air changes per hour, pressure differential, and consistent levels of temperature and humidity, the construction materials should be impermeable, have minimal shedding properties, and be easy to clean. In fact, frequent cleaning of the cleanroom is key to maintaining contamination control of a sterile products environment over the long term. Proper cleaning of controlled environments involves manual cleaning methods to reduce dirt and other foreign particulate matter, followed by chemical disinfection treatments to reduce contamination risk. Ultimately, cleaning frequency should be directly proportional to IV medication preparation activity; maintaining active environmental monitoring will provide feedback on the diligence of cleaning activities and allow for the optimization of cleaning frequency.
Equipment and Scheduling
Cleaning the cleanroom requires specialized equipment, including lint-free, disposable mop heads, non-shedding wipes, buckets made of plastic or stainless steel, and HEPA-filtered vacuums. Using the wrong equipment can actually contribute to higher contamination in the IV area. For example, if environmental services personnel are cleaning the cleanroom with the same cloth mop head used for general cleaning of the pharmacy, bathrooms, or other, non-sterile areas of the hospital, microorganisms can easily be introduced into the cleanroom.
It is important to establish cleaning and disinfection policies and procedures that specify which cleaners and sanitizers to use, as well as areas to be cleaned and frequency of cleaning. Cleaning personnel that enter the sterile products area should be given initial and supplemental training on proper aseptic gowning and garbing technique. As for scheduling, cleaning is best done during off-peak shifts, such as nights and weekends, and should be done frequently. In order to track long-term compliance, create a form that documents the cleaning process; the form should include the date and time, the area cleaned and disinfected, and the initials of the cleaning personnel.
Choosing the Right Cleaning Personnel
Implementation of a robust cleaning program begins and ends with practitioners. Therefore, the first decision should focus on determining who will actually perform the cleaning. Will it be members of your existing pharmacy staff? Will you look to engage staff from the hospital’s housekeeping or environmental services departments? Does it make more sense to employ an outside vendor with cleanroom cleaning expertise? This decision will have a major impact on the effectiveness of the cleaning program as each of these choices has various advantages and disadvantages.
If you decide to employ existing pharmacy technicians to clean the cleanroom, it is important to account for the additional labor capacity that will be required. One advantage of using existing pharmacy personnel is that they already have a strong intrinsic knowledge of IV preparation, equipment, documentation, and pharmacy culture. While employing pharmacy technicians in this way can be a cost-effective alternative, keep in mind that cleaning may be construed by pharmacy staff as a routine, mundane process that is detrimental to a successful career path—thereby potentially impacting their commitment to do the job well.
A second option is to employ hospital housekeeping or environmental services personnel. This also can be cost effective, but exercise caution as these staff members may not have appropriate training in proper aseptic techniques and personnel garbing processes needed to maintain USP Chapter compliance. If you choose to take this route, reinforce existing training with educational sessions on aseptic procedures and proper cleanroom compliance practices; it is important to emphasize the risk of contamination to IV medications that can result from improper cleaning and the impact on patient safety.
The third scenario is to hire a third-party vendor. When considering this approach, it is vital to evaluate the past experience of the company in cleaning and sanitizing cleanrooms. As there are a number of companies that now offer these services, this process will require proper due diligence; be sure to establish that the company has properly trained, certified, and experienced personnel, as well as the equipment, products, and solutions necessary to comply with regulations.
General Cleaning Procedures
Regardless of who performs the cleaning and sanitizing, it is important to have a basic understanding of how it should be done—even if you are relying on an experienced third-party provider. When cleaning the cleanroom, empty trash containers first and then vacuum ceilings, floors, and walls with a HEPA-filtered vacuum. Caution should be exercised when cleaning the delicate ceiling HEPA filters and should only be done using a vacuum with HEPA filtration. Cleaning HEPA filter grates with harsh solutions may damage the filters, allowing for microorganism penetration.
Cleaning and disinfecting of equipment such as laminar airflow workbenches (LAFWs) and other horizontal surfaces should be conducted with non-shedding, cleanroom-approved wipes. The physical process should flow from top to bottom and back to front in a unidirectional motion using single overlapping strokes. Floor mopping in the cleanroom should always be executed starting with the area furthest from the point of entry/exit. The operators should literally clean themselves out of the room. For mopping floors, a pull-lift technique should be employed (see Figure 1).
It is critical to comply with the manufacturer-specified contact time, as this allows for proper microbicidal activity to take place. There are automated mopping systems available, such as the MopKing product from AmKing Technologies, that ensure measured amounts of sanitizer are applied with each mop stroke and even provide documentation of time, area, number of mop strokes, amount of sanitizer used, etc. Whether the disinfectant is applied manually or automatically, allow the solution to remain on the surface for the time recommended by the specific product. Suggested sanitizers include LpH se, Vesphene II se, Bleach, and Spor-Klenz; each of which has different active ingredients (see Figure 2).
Given the prevalence of antibiotic-resistant microorganisms, such as MRSA and VRE, and the overall concern for nosocomial infections, cleaning programs are most effective when sanitizers and cleaning products are rotated on a periodic basis, which will help combat microorganism resistance in your cleanroom.
Monitoring Cleaning Effectiveness
It is important to frequently garner feedback on the effectiveness of your cleaning and sanitization program. This is best accomplished via -compliant environmental monitoring measuring viable and non-viable contaminant levels in the cleanroom. Viable particle monitoring evaluates microbial contamination on surfaces or in the air, while non-viable testing evaluates particle counts at specific size. Cleanrooms are classified according to the number and size of particles permitted per volume of air, and 0.5 micron particles are the most commonly measured size.
Particle counts are found to be directly proportional to bacterial contamination levels. Thus, environmental monitoring goes hand-in-hand with an effective sanitization program by providing a continuous feedback loop on the performance of the program. An effective environmental monitoring program should include sample sites, location maps, testing frequency, action/alert levels, and detailed test procedures, and must be governed by standard operating procedures (SOPs) that document the purpose, responsibility, and procedures necessary to the program. Monitoring results can be graphically trended over time and by location to demonstrate overall effectiveness and control of the cleaning/sanitization program.
Ultimately, proper cleaning and disinfection of your sterile products environment is key to compliance. It is a specialized service that greatly impacts contamination levels, and therefore the safety of both employees and patients. Simply using a sterile products cleanroom does little to protect your employees, patients, and the medications themselves if compliant cleaning practices are not strictly adhered to. Implementing, and most importantly, maintaining a proper cleanroom cleaning program is vital to your overall pharmacy operation.
Fran McAteer, MS, MBA, is vice president of quality at Microbiology Research Associates, Inc, an FDA-registered contract microbiology testing laboratory specializing in USP testing for pharmaceuticals, biologics, and medical devices. Fran has expertise and experience in the implementation of USP programs for hospital pharmacies, IV preparation, cleanroom engineering, and acts as a consultant for many hospitals.
Outsourced Cleaning Services Checklist
- Does the vendor have specific
expertise in cleanroom cleaning?
- Have they cleaned and disinfected other hospital pharmacy cleanrooms?
- Do they employ personnel who are trained in aseptic technique and
- Can they demonstrate a consistent track record in sanitizing cleanrooms?
- Will they provide appropriate cleanroom equipment and cleaning products?
- How do they measure and document their practices?
- Do they provide different levels and frequencies of cleaning, especially if there is a potential contamination event?
- Will they work during off-peak hours to minimize workflow interruptions?
- What are the pricing and contract stipulations?
- Acute Care Pharmaceuticals
- Alconox, Inc
- Aramark Cleanroom Services
- Aseptic Enclosures
- Benchmark Products
- Berkshire Corporation
- Blue Thunder Technologies, Inc
- ChemoGLO, LLC
- Clean Air Essentials
- Cleanroom Connection
- Cleanroom Consulting Services
- Connecticut Clean Room Corporation
- Contec, Inc
- Decon Laboratories, Inc
- Diversey Inc
- Dubin Medical, Inc
- Dycem Limited
- Ecolab Healthcare
- Essentra Porous Technologies
- Fagron, Inc
- Georgia-Pacific Professional
- Getinge USA Inc
- Health Care Logistics
- High-Tech Conversions, Inc
- ISO-MED, INC
- IsoTech Design Inc
- JOSCO Products
- Kimberly-Clark Professional
- Liberty Industries, Inc
- Med Effect, Inc
- Medi-Dose, Inc / EPS, Inc
- Medical Specialties Distributors, LLC
- Medtronic (A Cardinal Company)
- Metrex Research, LLC
- Micronova Manufacturing, Inc
- NCI (formerly Innotech Products, Inc)
- Nitritex (Ansell Healthcare)
- PDI Healthcare, Inc
- Perfex Corporation
- Safetec of America, Inc
- Steriplex SD
- STERIS Corporation
- TECHNOWIPE, Inc
- Terra Universal
- Total Pharmacy Supply, Inc
- Ultrapure Technology
- Valutek, Inc
- Veltek Associates, Inc
- Vileda Professional
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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