Outsourcing Facilities: Environmental Monitoring and Controls Critical in Drug Compounding
Drug compounding is the process of combining, mixing, or altering pharmaceutical ingredients to create a medication tailored to an individual patient's needs. Compounding can be as basic as the addition of flavoring to a poor-tasting medication or as advanced as the large-scale production of sterile medications prescribed by a hospital or other medical facility.
There are many community and hospital pharmacies that offer basic compounding, and most are only loosely regulated by the FDA and (to varying degrees) from state to state. On the other hand, registered outsourcing facilities that compound and distribute sterile drugs are subject to stringent state Board of Pharmacy regulations, inspections, and FDA CGMP standards. These include strict requirements for maintaining specified temperature, humidity, and air quality controls for safe production and storage of sterile compounded medications.
The HVAC systems typically utilized in these compounding facilities are 100% outside air once-through systems that incorporate HEPA filtration and tight operating ranges for both temperature and humidity. Room pressure and negative airflow must be precisely controlled, as well. Environmental integrity is continually monitored and trend-logged to prove compliance and alert users when excursions or other abnormalities occur. Redundant supply and exhaust systems are often present in compounding pharmacies to provide emergency backup and system maintenance, and some employ redundant exhaust in a lead/lag scenario to ensure that negative pressurization is not interrupted should a fan go down. Backup generators and uninterruptible power supply (UPS) are considered vital.
Regular, facility-specific HVAC preventive maintenance is critical to maintaining optimal environmental conditions in compounding pharmacies. Without it, systems can drift from setpoints for temperature, humidity, air changes, airflow, and static pressure. Proper PM helps prevent the excursions, alarms, failing systems, and other problems that can potentially shut down the production of urgently-needed medications.
MSC has extensive experience in the preventive maintenance, service, diagnostics, and design/build of cleanroom HVAC systems in drug compounding facilities.We work closely with our clients to design systems that accurately and effectively control their environment and to develop PM programs tailored to their specific facilities. MSC can also assist compounding pharmacies in writing a comprehensive standard operating procedure (SOP) to ensure consistency, repeatability, and full regulatory and standards compliance.