Compounding pharmacies have made news during the past year, and it has not been a pleasant time in the spotlight. In a dramatic and unfortunate scenario, New England Compounding Center’s tainted steroids were linked last fall to meningitis and other infections. The ensuing surprise inspections of compounding pharmacies in Massachusetts uncovered broader problems that ranged from citations for minor violations to facility shut downs. In all, only 10% passed inspection statewide. The director of the Massachusetts Department of Public Health’s Bureau of Health Care Safety and Quality said many of the problems pinpointed by investigators related to flaws in the design or operation of the companies’ cleanrooms.
To look further into the issue regarding design and control within compounding pharmacies, Controlled Environments spoke with Rick Meyer, President, Superior Laboratory Services Inc., Pasadena, Texas. Rick has 35 years’ experience in the construction, design, installation, consulting, repair, certification, and maintenance of laboratories, cleanrooms, and filtration systems. He has designed, built, consulted, and certified over 100 USP-797 facilities since 2004. In addition, Rick has tested/certified over 2,000 cleanrooms, designed/built over 900 cleanrooms, and certified over 75,000 hoods. He is a member of six IEST working groups, including HEPA leak testing, nano facility design, nano safety, and USP-797 facility design. Rick currently participates as a member of the ISO-14644 TAG team to review and comment on those standards.
Controlled Environments: How does facility design affect controls?
Rick Meyer: Poor design will and does lead to potential contamination. Items to watch are:
a) Seals of penetrations
• Lights are sealed ISO-7 cleanroom lights only
• Electrical switches and outlets
• Plumbing drains and supplies
• Fire alarms and sprinkler heads
• Door frames, latch holes, and hinges
• Ceiling tiles and grids
• Floors without integral coving
• Pressure, temperature, and humidity sensors
• Communication systems
All of the above have the potential to allow spiders, ants, roaches, or other insects to contaminate the cleanroom from wall cavities.
b) Supply and return air location
• Supply HEPA should be in the ceiling for first air in the room to be clean with no run to contaminate—and for ease of leak testing HEPA with the preferred method of scanning the HEPA.
• The return should be located at floor level and in all corners about six inches off the floor. Be sure that returns are not near doors or in the ceiling.
• Door sweeps are never recommended and neither are gaskets on the frame; they are just a source of potential contamination and very difficult to clean. Sliding doors have issues as well, and cleaning them is extremely difficult (i.e., tracks, roller wheels, gaskets between door and walls).
• Cabinets should be avoided by all means and laminates should never be used. Laminates are not smooth, impervious, free of cracks, crevasses, and/or seams. They also have wooden substrates that are not non-hydrophobic as are doors. We find our tops and bottoms to be exposed wood in many locations and see growth on them regularly.
CE: Can poor design be overcome?
RM: Not really, for the longer the facility is in operation the more you will realize the design flaws.
CE: What are some of the most common problems that you see?
RM: No low level exhaust in hazardous areas, such as chemo and nuclear pharmacies, and no low level returns in non-hazardous or low risk pharmacies. All of the responses to the first question are common problem areas. And certification reports are not detailed enough.
CE: In order to prevent cross-contamination, is the amount of space or the arrangement of the space most important? Or is it a balancing act?
RM: Arrangement of doors, HEPA location, and return location will help dramatically, but hood and movement in the rooms is a critical component as well. When designing a cleanroom, the size of the room and the number of occupants is extremely important. Be aware that the expansion for pharmacies is a foregone conclusion, so be prepared for the inevitable.
CE: Should (or can) a facility certify their own airflow and room pressure?
RM: I do not recommend this due to the expense of equipment, training of competent individuals to perform the tests, constant changes in the standards, and the issue of the fox guarding the hen house. There is also instrument calibration and continuous training for technicians to keep abreast of new techniques and instruments.
CE: What are the guidelines for appropriate intervals for certification?
RM: Every six months for certification is the minimum, and continuous monitoring will be required when and if the FDA gets their bill in the Senate passed.
CE: Anything else you would like to add?
RM: Gravity is your friend, and all particles larger than five microns are affected by it. A person is the dirtiest item that enters your cleanroom. HEPA filters should always be in the ceiling for first air, and test ports must be installed to accurately scan or test HEPA filters. There shouldn’t be cabinets in any room; sinks should be deep to limit splash; faucets should be foot pedaled with a tankless hot water system. Leave the area below the sink open for ease of cleaning and ease of plumbing failure recognition. I prefer doors to swing in and use pull handles to exit; this makes them hands-free like operating rooms. The room shouldn’t have ledges, and always use cleanroom lights. Get a competent consultant to work with an engineer and architect in designing your rooms—experience counts. Interlock supply and exhaust systems are needed if doing chemotherapy. And lastly, be sure HVAC systems are continuously running and are not turned off at night or on weekends.
This article appeared in the September 2013 issue of Controlled Environments.
