OSO BioPharmaceuticals Manufacturing LLC is investing more than $5 million in equipment and infrastructural improvements that include a new Grade A aseptic filling suite for liquid, suspension and lyophilized products.
The rolling diaphragm pump filling suite, manufactured by Bosch, comes equipped with optional rotary piston and peristaltic pumps. It will function at 115 percent of the previous line’s capacity, increasing the speed and efficiency with which OsoBio can deliver drug products to clients.
Thanks to its ability to conduct non-destructive online weight tests, the new line will deliver greater precision and yield. And its restricted access barrier system will minimize risk of cross-contamination and diminish potential occupational exposure.
OsoBio is a contract manufacturing organization (CMO) that produces injectable sterile liquids, suspension and lyophilized biologic and pharmaceutical products for the pharmaceutical industry.
“This state-of-the-art filling suite represents a substantial investment in the future – the future of OsoBio, as well as the futures of the pharmaceutical clients we serve,” said Milton Boyer, president. “It allows OsoBio to manufacture drugs in a better, smarter and faster manner, while ensuring high-quality product and the safety of patients and employees alike. This is an exciting new addition to OsoBio’s facility.”
In preparation for the new line, OsoBio extensively remodeled its facility, making infrastructural enhancements that included installing welded PVC walls throughout controlled and classified areas to further secure the sterile environment and improve durability, ease of use and maintenance. OsoBio also installed poured epoxy floors throughout its facility to support its strong record of industrial safety.
The new line produces sterile liquid, suspension and lyophilized formulations in vial sizes ranging from 2cc to 100cc. The Bosch equipment includes:
• An RRU 3084/44 high-performance container washing machine, which uses intensive flooding, ultrasonic and spraying techniques to reliably clean vials inside and out in a continuous process,
• An HQL 4480S drying and sterilization tunnel with laminar flow for depyrogenization and cooling of glass vials,
• An FLC 3080 filling and closing machine designed to fill, sample check-weigh and stopper vials in a continuous motion process in compliance with International Organization for Standardization requirements,
• A GLT 4040 tray loader with 100-percent vial counting accuracy, and
• A TRL 1030 tray loader designed to automatically load vials at high speed in cleanroom applications, requiring minimal interaction and maintaining Good Manufacturing Practices (GMP) standards.
OsoBio’s new filling suite should be installed, fully validated and operational by late August.
Headquartered in Albuquerque, N.M., OsoBio specializes in products requiring complex handling, including highly potent compounds. Responsiveness, attention to detail and clear communication are the hallmarks of our client care.
Source: Oso BioPharmaceuticals