SAN DIEGO, CA – MediZap, North America’s leading turn-key service provider of e-beam terminal sterilization for compounded pharmaceuticals has partnered with Analytical Lab Group, now part of Element Materials Technology (Element), to offer sterile compounding testing services and more to its pharmaceutical compounding clients.
The partnership adds another layer of value to the MediZap program by expanding its services to include USP <797>, USP <800>, and cGMP FDA compliance expertise and testing solutions for compounded pharmaceuticals.
The partnership is a direct integration with MediZap’s Four Pillar Service, with ALG-Element offering services in the areas of research and development testing, safety and compliance testing, stability testing, container closure testing and quality assurance testing.
MediZap clients can expect these primary benefits, and more, from this exclusive partnership with ALG-Element:
- Peel Off Sample Submission – Samples are taken from the terminal sterilization run for compendial quality control testing. Samples are pulled post-sterilization and immediately sent to the ALG-Element microbiology lab for testing, saving the client significant time and money.
- Q-Alerts – When a client has a quality event that potentially affects drug safety or stability, the joint team effort between MediZap, ALG-Element and the client immediately launches a quality investigation and quickly and effectively identifies the single root cause in a unified manner.
- Advanced Technology for Testing Services – ALG-Element sterile compounding testing services includes Rapid Sterility USP <1223> BacT | ALERT®, Sterility USP <71>, Endotoxin USP <85>, Bioburden USP <61>, and USP <62> to help clients keep their projects on schedule, reduce product waste, validate the efficacy and purity of products, and get their products to market faster.
Analytical Lab Group, which was recently acquired by Element Materials Technology (Element) is an industry-leading specialty contract lab, comprising FDA- and EPA-focused laboratories across the United States. It is a GLP/cGMP compliant, FDA registered, DEA registered, and ISO/IEC 17025:2017 accredited company dedicated to pharmaceutical testing solutions.
“The partnership with ALG-Element further supports MediZap’s commitment to helping innovative 503A and 503B compounding pharmacies, small pharmaceutical companies, and schools of pharmacy meet the ever-tightening USP <797> guidelines for sterile compounding assurance regulated by the State Boards of Pharmacy and FDA. It allows us to offer clients a full spectrum of small lot testing and sterilization services to overcome historic sterilization validation methodologies and keep their projects on track and get their products to market faster. We are excited to integrate ALG-Element’s services into our own Four Pillar Service that has made MediZap a leader in the terminal sterilization industry,” said Jonathan Bergstrom, CEO of MediZap.
Sterile drug manufacturing now starts with terminal sterilization, such as MediZap’s exclusive E-Beam Terminal Sterilization technology, providing customers with the highest standard of sterilization. Terminal sterilization provides an FDA/ISO validated sterilization process, creates a benchmark for sterilization across the industry, standardizes third-party accountability for testing, and saves money in terms of in-house equipment, staff and documentation.
MediZap is North America’s premier turn-key service provider of cutting-edge e-beam terminal sterilization for compounded pharmaceuticals. They provide an all-inclusive program with E-Beam Sterilization, Packaging Solutions, Compliance, and Exclusive Partnerships, allowing them to offer a world-class client experience. Utilizing a network of compounding pharmacies, outsourcing facilities, and pharmaceutical companies across North America, MediZap clients can leverage exclusive line capacity, group pricing, and shared industry knowledge and trends.
ALG is an industry leader in the specialty contract lab space and comprise FDA- and EPA-focused laboratories across the United States, with facilities in the San Francisco, Minneapolis and Boston areas. The ALG team is focused on Helping Protect Life® through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech and healthcare spaces. Their facilities are GLP/cGMP compliant, FDA registered, DEA registered and ISO/IEC 17025:2017 accredited.
Element, one of the world’s leading independent providers of testing, inspection and certification services to a diverse range of industries, where failure in service is simply not an option.