Specialized PM, Diagnostics, and Repair are Critical for Compounding Pharmacy HVAC Systems
Compounding is the creation of a pharmaceutical preparation that meet the unique needs of in individual patient when a commercially available drug does not meet those needs. For example, a patient may be allergic to an ingredient in the commercial version, or may require a smaller liquid dose of a drug commonly made in tablets. While most pharmacies offer some level of compounding, a compounding pharmacy is a facility in which preparations are produced by specially-trained pharmacists in cleanrooms that meet strict environmental standards. About 7,500 pharmacies in the U.S. currently specialize in compounding services, and compounding often takes place in hospital pharmacies and other healthcare facilities.
Compounding pharmacies and cleanrooms must follow stringent HVAC standards and regulations to maintain the required environmental controls to safely produce and store medicines. Integrity of the environment must be monitored and trend-logged to show compliance and alert users when excursions or other abnormalities occur. Specialized HVAC systems utilized in compounding pharmacies are typically 100% outside air, once-through systems that incorporate HEPA filtration and tight operating ranges for both temperature and humidity. Room pressurization and negative airflow must be monitored on a continual basis. Some compounding pharmacies install redundant supply and exhaust systems for emergency backup and system maintenance. Others have redundant exhaust in a lead/lag scenario to ensure that, should one fan go down, negative pressurization is not interrupted. A backup generator and an uninterruptible power supply (UPS) are vital.
Regular, facility-specific preventive maintenance is critical to maintaining optimal HVAC system conditions in compounding pharmacies. Without the appropriate PM, systems can drift from setpoint, which includes temperature, humidity, air changes, airflow, and static pressure. Excursions, alarms, tripping and failing systems, and other environmental issues can shut down operations, a dire situation in a facility that produces urgently-needed drugs. Preventive maintenance is the best protection against these issues.
As a service subspecialist in the technical intricacies of HVAC, process cooling, and building automation, Mechanical Service Corporation | MSC has extensive experience in the preventive maintenance, service and diagnostics of compounding pharmacy and cleanroom HVAC systems. We work closely with compounding pharmacies to design highly-customized preventive maintenance programs, and we ensure that their HVAC systems meet all set standards and strictly comply with all regulations set by authorities having jurisdiction. While a Standard Operating Procedure (SOP) outlining monthly, quarterly, and annual maintenance items and procedures for HVAC systems should be supplied to the client at the time of commissioning, this is not always the case. MSC can help compounding pharmacies develop a detailed SOP if one was not provided at the time of commissioning.