Pace Analytical Life Sciences (PLS) has recently made significant investments to upgrade our capabilities and capacity for Total Organic Carbon (TOC) USP/EP testing. We have upgraded and standardized our equipment: we have purchased three new instruments and placed one within each of our FDA-registered, GMP-compliant testing laboratories:
- Oakdale, Minnesota
- Somerset, New Jersey
- San German, Puerto Rico
In addition, we have modified and validated the internal methods we use to perform Total Organic Carbon (TOC) USP/EP testing. The new method can be used for the testing of purified water samples and the testing of aqueous extracts. It is a method with the quantification, range, and sensitivity to support the updated requirements of USP <661>, general chapters for evaluation of plastic packaging components.
Our new method, LM 286, “Quantitative Determination of Total Organic Carbon”, outlines the requirements for the analysis of Total Organic Carbon in accordance with several compendia chapters, including: EP 2.2.44, USP <643>, and USP <661>. This method has been formally validated and documented under a formal validation protocol. We will be happy to share with clients a copy of the validation report for LM 286, upon request.
These investments in equipment and a properly validated method allows Pace Analytical Life Sciences to support all your facility monitoring programs, your water system validation projects, and your raw material and packaging testing programs. By using the same method and equipment in each of our three GMP testing labs, you have the assurance of consistent and reliable data, regardless of where the testing is completed. This also provides ready access to immediate capacity; any of our laboratories can provide support to large projects and to prevent service interruptions if one facility is constrained.
About Pace Analytical Life Sciences
Pace Analytical Life Sciences is a network of full-service contract analytical testing laboratories providing chemistry and microbiology testing services to the Pharmaceutical, Biopharmaceutical, Medical Device, and Combination Product manufacturing industries. Our investment in state-of-the-art facilities and highly trained personnel emphasizes our commitment to delivering positive customer experiences across all channels of our business. We are dedicated to providing not only the best in analytical testing services, but also the most reliable. We are well-equipped to handle almost any project regardless of scope or complexity. Founded in 2006, Pace Analytical operates FDA-registered laboratory testing facilities in Oakdale, Minnesota, San German, Puerto Rico, and Somerset, New Jersey.
Pace Analytical Life Sciences operates a subsidiary, Wolfe Laboratories, Inc. Wolfe Laboratories is a premier contract research organization that provides integrated drug development solutions to the biopharmaceutical industry. Wolfe Laboratories is recognized as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development. Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that goal by embracing our core values of integrity, excellence and teamwork. The company has a high percentage of repeat clients, which is a testament to its long-term commitment of continual investment in its capabilities to meet biopharma’s growing demand for high quality, integrated early development services. Founded in 1999, the site is located in Woburn, Massachusetts.
For more information, please visit Pace Life Sciences
Director, Business Development
James Wheeler at (651) 738-2728