19 Jul What is a Compounding Cleanroom? A Quick Guide
Deep within pharmacies and other healthcare settings, compounding cleanrooms work like secret laboratories, where medications are crafted specifically for individuals. These highly-controlled environments ensure that each dose is free from dangerous particle contamination, and therefore meets the highest standards of safety. In this article, we’ll define what a compounding cleanroom is, and cover the rules and regulations that typically govern them.
What is a Compounding Cleanroom?
A compounding cleanroom is a controlled environment where pharmacists or other healthcare professionals create personalized medications for patients. Compounding is when the form of medication is altered, whether through changing the dose or mixing different medications together. This is done when commercial medications are not sufficient for specific patient needs. Compounding cleanrooms protect the compounding process by keeping spaces free of microbial and other contamination.
Regulations and Standards
To keep spaces as clean as possible and to ensure that patients are not harmed, compounding cleanrooms are bound by strict regulations. The most relevant guidelines come from the United States Pharmacopeia (USP) and the International Organization for Standardization (ISO).
ISO Standards
ISO standards provide classifications for maintaining air quality and cleanliness in cleanrooms. Compounding cleanrooms usually require ISO Class 7 or better conditions. High-efficiency particulate air (HEPA) filters and other advanced technology are typically used in these spaces to remove and keep out particles, ensuring that the air quality meets the right standards.
USP <797>
Similarly, USP <797> is a set of guidelines to ensure that compounded sterile preparations (CSPs) are sterile and free from contamination. It covers all sterile compounding, including hazardous and non-hazardous drugs. Some key aspects include:
- Engineering Controls: Use of Primary Engineering Controls (PECs) like laminar airflow workbenches and biological safety cabinets (BSCs); Secondary Engineering Controls (SECs) like cleanrooms; and segregated compounding areas (SCAs) with HEPA filtration. Cleanrooms must meet ISO Class 7 for buffer areas and ISO Class 8 for anterooms.
- Personal Protective Equipment (PPE): Requirements include gowns, gloves, masks, shoe covers, and more.
- Environmental Monitoring: Regular air and surface sampling, and particle counting.
- Documentation: Detailed records of compounding processes, sampling logs, and cleaning procedures.
- Training: Personnel must be trained in aseptic techniques, PPE use, and maintaining cleanliness.
USP <800>
USP <800>, on the other hand, focuses specifically on the safe handling of hazardous drugs to protect healthcare workers and patients. This includes:
- Containment Controls: Use of containment primary engineering controls (C-PECs), such as biological safety cabinets or compounding aseptic containment isolators, to protect workers from exposure to hazardous drugs.
- Design: Requirements for the physical layout of the cleanroom to minimize exposure risks.
- Environmental Monitoring and Decontamination: Protocols to ensure a safe working environment, including regular decontamination and environmental monitoring.
The Bottom Line
Compounding cleanrooms are important for the safe and effective preparation of personalized medications, or CSPs. By following regulations such as ISO, USP <797>, and USP <800>, these cleanrooms become the backbone of medication safety and quality. Understanding and following these regulations is crucial for designing and operating a compliant compounding cleanroom.
Want to speak with the experts? Contact Allied Cleanrooms today to get a free quote on a new compounding cleanroom.