A robust viable sampling plan is validation that your processes produce sterile products. Critical areas to your process need to be sterile under working conditions. Air Safe performs viable sampling under dynamic conditions within your hoods as well as in your buffer and ante rooms. Contact Air Safe to learn more about what you should already be doing.
Air Safe embraced viable air sampling early on, before the current USP <797> document became effective. An excellent tool for ensuring aseptic techniques and effective cleaning procedures are being utilized to minimize the level of bio-burden in your clean environment. With our experience, we can help you implement procedures to reduce these levels of potential contamination. We keep historical data so we are able to monitor the trends in the monitoring and notify you of any abnormalities within the monitoring.
Environmental monitoring is one of the most important tests we offer to our pharmacy clients. As required for compliance with USP <797> and FDA 503A/B standards, pharmacy air in controlled environments is sampled via an active air sampler which impacts a metered volume of air onto agar media plates. These samples, along with surface contact samples, are sent to an accredited laboratory for identification of any colony growth. These laboratory reports are included in your final certification report.