You need to get your product to market quickly and safely. Element offers options to validate your product sterility and meet your project deadlines.
USP <71> Sterility Testing
Standard USP <71> sterility testing, essential to sterile compounders, outsourcing facilities and manufacturers, has a 14-day incubation time.
Rapid Sterility Testing with BacT/ALERT® 3D Dual-T
With Element's rapid sterility testing, results are available in seven days, half the time of the standard USP <71> test. We use BacT/ALERT® 3D Dual-T, the first fully automated, growth-based, dual-temperature microbial detection system. Our comparability studies conform to USP <1223>.
Ensuring product sterility is critical to patient health and safety, so timely testing turnaround is essential to delivering critical medicines to the patients who depend on them. To learn more about Element's sterility testing options, contact us today.
We provide USP <797> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing facilities.
Element offers GLP and cGMP virology testing options to serve our clients in the antimicrobial and pharmaceutical industries.
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.