Contamination pose a serious threat to the safety and integrity of compounded pharmaceutical products. USP <797> outlines the steps that need to be taken to maintain a safe, contaminant-free cleanroom.
Preventative action and early detection of possible sources of contaminants can help pharmacies stay compliant with FDA regulations.
The following four actions are a good starting place for keeping your compounding pharmacy clean:
The first step to maintaining a clean cleanroom is identifying potential sources of contamination. Microorganisms can survive and grow on humans and in water, which are considered to be primary sources of contamination. Contaminants are transferred from humans and water to secondary sources, like air and surfaces, where they survive but do not grow.
Failures in engineering controls and incorrect aseptic techniques can also lead to cleanroom contamination.
Following a regular cleaning schedule will help prevent contamination in cleanroom pharmacies. Each pharmacy should develop their own cleaning scheduled and protocols based on USP guidelines.
Proper gowning and hand hygiene will help eliminate human-borne contaminants. Each compounding pharmacy should develop and maintain SOPs based on USP guidelines for gowning and hand hygiene.
The following gowning and hand hygiene procedures are recommended:
Viable particles contain living microorganisms, are able to germinate and impact the sterility of compounded products. Fungi, bacteria, viruses and spores are all viable particles. Non-viable particles are organic particles in the air that do not contain living microorganisms but can transport them. Particulates like dust, dirt, pollen, fibers, rust and chemical compounds are considered to be non-viable particles.
It is critical to monitor cleanroom air and surfaces for both viable and non-viable particles, as they can negatively affect the sterility of compounded products. Each pharmacy should develop a schedule and SOPs for environmental monitoring based on USP <797> guidelines.
Proper environmental monitoring, preventative actions and process improvements are critical for staying compliant with FDA regulations. DiNovo Pharmacy and Packing Provisions is here to help. We sell all environmental monitoring products, including garbing materials, sample plates, air monitoring devices, cleaning supplies and more.
We can also help pharmacies develop SOPs for cleaning, garbing and environmental monitoring. Reach out to our sales team at. email@example.com to view the recording of our Environmental Monitoring webinar with Veltek Associates.
Oversight of the compounding industry is increasing. At DiNovo, we put patient safety first. We provide supplies for 503A and 503B pharmacies, including supplies for packing and shipping, cleaning and disinfecting, and compounding. Contact us today or download our compliance checklist to learn more.