Pharmacists can be in control of their cleanroom environment by understanding the critical elements.
Although the USP 797 mandate had a January 1, 2008 deadline, the buzz in the pharmacy industry is still, “What do we need?”; “What is a cleanroom?”; “What do we need to consider?” A lot of the pharmacists we have spoken to have voiced these concerns. Stating that they have read the mandate but are still confused has been a constant complaint. Those in the pharmacy industry are well versed in compounding medications, but are unsure as to what an ISO 7 ante room, an ISO 7 buffer zone, and an ISO 5 compounding zone are. What does the ISO mean? This has been a constant question throughout this industry.
The main points pharmacists need to track and be aware of are ergonomic flow of the design, environmental controls of the room (temperature, humidity, pressure, and particle counts), and gowning and cleaning protocols. Knowing these elements will enable pharmacists to be empowered about their cleanroom needs for this mandate.
The ergonomic flow of the design is the first crucial step in creating a cleanroom environment to fit pharmacists’ needs. Pharmacists’ input to the architect/cleanroom contractor about their day to day operations is vital to the design of their cleanroom environment. Because pharmacists understand their processes and workflow better than the architects or cleanroom contractors, they need to play a major role in the design of the room. An open dialogue is a must to ensure that you receive the best cleanroom to meet your pharmacists’ needs.
There have been a lot of design flow complaints from pharmacists that have had cleanrooms built without their design input. From having a sink in the farthest location from the ante room entrance door to chemo-compounding BSCs being placed in ante rooms, there have been many disappointments in the industry.
Now that you have supplied your input and have your cleanroom in place, what is critical to maintaining your environment? What is vital to quality assurance? Temperature, humidity, room pressure, particle counts, and microbial contaminants are the key elements to monitor and control. The temperature, humidity, and room pressure must be logged on a daily basis. What temperature is required? What is the gauge for humidity? What pressure differential should be observed? These are all common questions that pharmacists have once their room is built.
The temperature should always be maintained below 20° Celsius. Anything above this temperature becomes a risk for microbial contamination and is uncomfortable for the gowned technicians. The relative humidity should be maintained between 35-65%RH. This is most comfortable for employees and inhibits the growth of microbial contaminants. The pressure differential between the ante room and dry pharmacy is to be not less than 5Pa (0.02WC) and the buffer zone to the ante room should be 6.2-12.5Pa (.025-.05WC). These three components must be read and logged at each shift or a minimum of once a day.
Particle counts and microbial contaminant screening are a major role of quality assurance. Particle counts must be monitored and certified at least every six months by a certification company that is utilizing the appropriate monitoring systems. The acceptable count for the ISO 8 is >3,520,000 particles at .5μm; ISO 7 is >352,000 particles at .5μm; ISO 5 is 3,520 particles at .5μm. A continuous particle and environmental monitoring system is an ideal option to install. This device can control and validate particle counts, temperature, humidity, and pressure gauges all in one. The data can be accessible from any connected computer and can be manipulated to adjust environmental elements with the click of a button.
GOWNING AND CLEANING PROTOCOLS
Surfaces and personnel attire growth media samplings are also part of the USP 797 mandate. Surface sampling utilizing contact plates and swabs (for irregular surfaces) must be performed on a periodic basis. A general microbiological growth medium like a soybeancasein digests medium or a TSA should be utilized to test surfaces. For high risk compounding, a malt extract agar or equivalent should be utilized to test for the growth of fungi. Swabbing of surfaces is recommended for irregular surfaces such as bins, ceiling tiles, etc. This growth media process can be done in-house or sent to a third party for validation.
Personnel microbial growth testing requires training on the proper gowning procedures. The fingertip or glove testing must be completed before any personnel compounding for human consumption can begin. This test involves the technician properly donning attire and gloves and then the evaluator sampling the fingers and thumb onto an appropriate agar plate. This test must have a reading of zero cfu and be completed three times, before a technician is able to compound CSPs for human consumption. The evaluator must be certain that the individual testing does not utilize 70% isopropyl alcohol on their gloves prior to testing. This test must confirm that technicians are able to don the appropriate attire without contaminating their gown/gloves.
The proper gowning protocol is a must and one of the biggest contentions for pharmacists and their staff. This procedure is vital to protecting the end product for human consumption. The pharmacy staff is not used to washing hands, gloving, covering hair and face, and gowning. But, proper gowning protects the end product from the biggest contaminant — humans. A strict training process and protocol is the best way to enforce this procedure. One of the biggest sources of microbial contamination is make-up and jewelry. These two elements are not permitted in a cleanroom environment. At first, the gowning process and practice will be a time consuming endeavor but will become second nature to the pharmacist with practice.
Another important component of controlling your USP 797 cleanroom environment is the constant cleaning protocol. Following a regimented cleaning protocol will ensure the particle and microbial contaminants are kept to a minimum/non-existent level. Floors, work surfaces, and material carts are to be cleaned daily. Ceilings, walls, and pass-throughs are to be cleaned monthly. Keeping a cleaning log is recommended and will assist the facility in maintaining and following the proper protocol.
There are a lot of components to properly maintain and control the environment of a USP 797 cleanroom. The first element to have under control is the design/ergonomic flow. After your cleanroom has been built there is more to control and monitor to ensure the safety of the end product. Safety of the end product is safety to the general public. Being in control of your cleanroom is extremely important and will become less of a burden once the protocol has been adopted as second nature.
Heather Wylie is Co-Founder and President of Haddad-Wylie Industries (HWI Global). In the cleanroom industry for six years, Heather received her BA from Carlow University in Education. HWI Global, 3840 South Water Street, Pittsburgh, PA 15203; (412) 884-3028; www.hwicleanrooms.com.