Rest assured our Pii experts will monitor, manage and complete the production of clinical and commercial sterile injectable products with our cGMP filling lines, robotics single-use and isolator-barrier systems, in accordance with all cGMP requirements and QbD principles.
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Our Pharmaceutics Know-How™ accelerates the development of parenteral formulations for clinical trials and improves your decision-making from concept to clinic and commercialization. We have the proven experience, modern equipment and facilities to develop and supply injectable products (IV, IM and SC) and formulations including:
Our proven and experienced team of scientists, engineers and regulatory affairs professionals serves you through the entire process, from pharmaceutical development, clinical trial manufacturing and analytical testing to regulatory filing and commercialization — all in strict accordance of cGMP requirements and utilizing QbD principles. Our state-of-the-art facility includes equipment and filling lines from AST, M&O Perry, Groninger, Fedegari and Millrock.
Sterile products processed using single use technology in strict accordance with cGMP requirements. Process all ready-to-use nested, vial, syringe and cartridge formats for clinical and small and medium-batch commercial applications.
Small-batch, flexible Aseptic filling & closing
The GENiSYS® R filling line provides reliable and flexible processing, minimizes manual operations, and reduces product waste, common at the beginning and end of batch manufacturing. Eliminating waste is key to successful small batch processing. Necessary operations such as pump calibration, in-process fill weight checks and residual product hold-up in the fluid path all contribute to product rejects. The GENiSYS® R’s in-process control system allows for 100% fill weight inspection with minimal reduction in processing speeds to minimize or even eliminate improperly filled containers and minimize product hold-up at the end of the batch – resulting in maximize product yield. In addition, the Electronic Batch Record (EBR) system provides a complete record of the dispensed material.
