Helping you ensure patient safety and demonstrate a microbial state of control
We're dedicated to helping you monitor the state of environmental control, safeguarding the safety of patients, end-users, and equipment operators. You’ll get the personalized support you deserve from accessible subject matter experts and highly trained, gown-qualified technicians - we’re committed to delivering a truly seamless experience. If you're ready to get started, click the orange "Get more information" button and fill out the form. Our team will be in touch with you.
We'll help make regulatory compliance easier
You can focus on your core business while our experts carry out comprehensive environmental monitoring (EM) and microbiological laboratory services. We know that time is precious - that's why we deliver accurate data quickly and help streamline processes, tailoring our services to meet your unique needs.
You'll have confidence in the data-driven decisions you make for your operation. Our quality-centric, “first time right” mentality and stringent processes and controls uphold the utmost quality and integrity of your data. Plus, staying up to date with regulatory changes is easy with Element - you can rely on our deep expertise in USP standards, FDA guidance, and State Board of Pharmacy requirements.
Experience seamless, dedicated support
From consulting to sample processing and reporting to remediation support, we operate as part of your team, and are with you every step of the way. We provide dedicated support, including education and training in proper aseptic practices for your staff, and you'll get world-class technical support from easily accessible subject matter experts.
When you partner with Element, you'll have access to an unparalleled blend of experience, staff development and training, and extensive regulatory, industry, and scientific knowledge. To explore a partnership with Element, fill out a short form and a member of our team will be in touch with you.
Your partner in success
As your partner in success, we’re invested in delivering efficient and effective solutions. You can rest assured we hold the accreditations you need - we're ISO 17025 and A2LA accredited, in addition to being registered with the FDA.
Leverage our wealth of knowledge and demonstrated history of success designing robust microbiological EM programs for compounding pharmacies and pharmaceutical, biotech, and medical device manufacturing companies. If you're interested in knowing more, just fill out a short form. A member of our team will be in touch with you.
Get to know Element
Scroll down to explore a handful of the many services we offer to help you ensure regulatory compliance.
Your global partner in ensuring patient safety
Interested in seeing what more Element has to offer? Here are a handful of our many services to help you ensure patient safety.
Environmental Monitoring
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
Compounding Pharmacies
We provide USP <797> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing facilities.
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.
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.
Media-Fill Test Kits
Our media-fill test kit program provides aseptic compounding proficiency test kits that validate confidence in your aseptic procedures.
Client Portal
Secure 24/7 access to your test result information, which you can download directly to your information management system.