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.
Key Benefits of Compounding Pharmacies with Element
- Expertise & Support - Element offers a deep understanding of sterile compounding regulations and best practices. Our team of microbiologists provide technical support, helping clients stablish effective environmental monitoring plans and address contamination issues.
- Comprehensive Services - We provide a full suite of environmental monitoring and product testing services, including air and surface sampling, particulate counts, media-fill testing, sterility, endotoxin testing, and more. This comprehensive approach simplifies the compliance process for you.
- Focus on Compounding - By outsourcing environmental monitoring and product testing to Element, you can concentrate on the core competency: patient care. This allows you to allocate more resources to compounding and improving patient outcomes.
Supporting you through regulatory compliance
Sterile compounding facilities face complex and evolving regulatory challenges. Element offers expert guidance and support to ensure compliance with USP and other standards, helping you avoid costly errors through tailored environmental monitoring plans and regulatory interpretation.
Cost-effective, tailored solutions
Sterile compounding demands significant investments in time, personnel, and equipment. Element offers a cost-effective solution by handling your environmental monitoring and product testing needs. Our dedicated team frees up your staff to focus on the core compounding activities, improving efficiency, and patient care. By partnering with Element, you optimize your resources while maintaining the highest quality standards.
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.
Our range of related services
Full service on-site EM from gown-qualified and train technicians:
- Aseptic Manipulation Competency
- Hand Hygiene and Garbing Competency
- Total Airborne Particle Sampling
- Viable air and surface sampling
- Investigational sampling
- EM Performance Qualification (PQ) services (where applicable)
- Cleanroom certification via our third-party partner
ISO 17025 accredited microbiology services:
- Incubation, enumeration, and genus level identification
- Growth promotion testing of media
- USP <1072> Disinfectant Efficacy Testing (where applicable)
- USP <71> Sterility Testing (where applicable)
- Electronic Certificates of Analysis
Why choose Element
Element delivers comprehensive environmental monitoring and product testing solutions for sterile compounding facilities. Our expert team ensures regulatory compliance, minimizes contamination risks, and optimizes your operations. By partnering with Element, you gain a strategic advantage in maintaining the highest quality standards while focusing on patient care. 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.
“Very pleased with the assistance that Element provides with monthly microbial monitoring. They were also instrumental in helping develop a new testing plan for our new cleanroom suit.”
Craig N Jones
Brigham and Womens Faulkner Hospital
Learn more
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.
Disinfection Qualification
Element offers Disinfection Qualification studies for the pharmaceutical industry and Disinfectant Efficacy studies for the antimicrobial industry.
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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