Whether you need to use a contractor or are doing it yourself, Element will be your trusted Environmental Monitoring and product testing service provider. We support a wide range of clients compounding for human and veterinary use including 503A sterile compounders and 503B outsourcing facilities, home infusion providers, and oncology clinics.
From technical support in establishing an Environmental Monitoring plan, performing sample collection, remediation assistance, and data trending, Element can offer the best experience to meet the requirements of your state pharmacy board and regulatory auditing bodies.
Environmental Monitoring
Focus on compounding and let Element perform your full-service on-site EM. We will execute your monitoring plan for viable air samples, viable surface samples, total particulate counts, media-fill testing, as well as gloved fingertip and thumb sampling. If your EM is performed in-house, we can process all of the aforementioned at select Element locations with the same level of support before, during, and after the service!
Sterility & Endotoxin Testing
If you’re compounding under Category 2 or Category 3 and/or meet the conditions to require product testing, we can offer USP <71> Sterility testing via Membrane Filtration or Direct Inoculation. For endotoxin testing, we offer USP <85> Kinetic Chromogenic and Turbidimetric methods.
Connect with a Technical Expert
Our team of microbiologists and easily accessible industry experts are ready to answer your questions. For more information about our compounding pharmacies testing services or to request a quote, contact us today.
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Sterility and Rapid Sterility
Ensuring product sterility is critical to patient health and safety, so a fast turnaround time is essential to delivering critical medicines to the patients who depend on them. Element offers USP <71> Sterility testing and rapid sterility testing options.71>
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Disinfection Qualification
Element offers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.
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Environmental Monitoring
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
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