By Thomas Licker, CEICR, CBRM
Pharmaceutical Compounding Laboratories have been the talk of the town of late. “Pharmaceutical compounding”, the art and science of creating custom medications to meet a patient’s specific needs (strength, dosage, flavors, ingredients), takes place in lab facilities with stringent environmental requirements. One of the most challenging of these for Facility Managers is maintaining sterility in negative pressure clean rooms.
The guidance for maintaining compounding laboratories is outlined by the US Pharmacopeial Convention (USP), with environmental focuses discussed in (795) Nonsterile Preparations, (797) Sterile Preparations and (800) Hazardous Drugs—Handling in Healthcare Settings. It is essential that while implementing the recommended controls the lab environment is well-monitored and that sterility failure is immediately identified and addressed.
What causes contamination in negative pressure clean rooms?
The rooms that make up the sterile space, including the Isolators, are under negative pressure which brings “make up” air in – along with airborne contaminants. Engineering controls such as HEPA filtration or the use of ultra-low particulate air filters (ULPA) can help mitigate issues with cross contamination. The environment should be cleanroom specific and have a properly gasketed drop ceiling. When possible, it is best to install a microbial-resistant sheet rock ceiling if there aren’t too many utilities that require access.
So what if there are continued room failures? Facilities Engineers, Environmental Services and the pharmacy personnel come together to finding the source of the contamination. An evaluation by a specialized contractor will expedite the process of identifying the potential problems and working through a process of elimination to find a solution to the issues plaguing the facility.
How to identify the source of contamination in clean rooms
- Verify room pressurization. Is the laboratory properly balanced across the Work Room, Ante-room, Clean-room, and Isolator spaces?
- Evaluate the laboratory construction. Sometimes the solution lies behind the exterior walls:
- Is it properly sealed? (Fire blocking)
- Is it properly insulated?
- Is there evidence of uncontrolled intrusion from the exterior or other source of moisture? Conduct Air Sampling from potential intrusion sources, and check for intrusion of uncontrolled sources around outlets and fixtures.
- Examine building materials. Are the walls constructed of microbial-resistant wall board?
- Assess Personal Protective Equipment (PPE) protocols. Is it being brought in by the laboratory workers? Observe donning and doffing procedures, and implement periodic validation sampling of sterile PPE.
- Identify other potential sources of contamination in the space. Perform a thorough review of all procedures and standards followed by lab personnel.
Laboratory facility hygiene issues can cause panic and concern, especially in specialty controlled environments. Cross-contamination can come from a wide variety of variables: Aging facilities might need a complete renovation, a new location, or a move to newly-popular customizable mobile laboratory units. Best practices can be overlooked in the construction of brand new labs as pressure to complete the facility on time may be a factor. The important thing to do is bring any facility hygiene issues to light quickly and address them from the front end. Putting temporary measures in to pass environmental testing may only prolong exposure and add unnecessary anxiety to the process. Regularly scheduled room-space sterilization or outsourced terminal cleaning will help maintain to environmental standards and mitigate future room failures.
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