Innovative, integrated process equipment for the freeze drying of oncological products developed by Telstar has been installed at Italian company BSP Pharmaceuticals.
The complex installation consists of two large-scale pass-through lyophilizers (30m2) with a fully automated ‘push-in/pull-out’ type constant level loading and unloading system. Conceived for use in the manufacturing process of oncological products, the equipment has been designed to be integrated within aseptic isolators requiring high level protection for the operator (OEL5), the product (ISO5) and the environment.
The automatic push-in/pull-out vial loading and unloading systems which are integrated to each of two lyophilizers have been designed to operate effectively both in aseptic conditions for product protection and under contained conditions for operator protection. The system includes a patented compact drive system featuring flexible steel bands especially suited to use within ISO5 aseptic zones.
The freeze drying equipment developed by Telstar has been designed in a vertical configuration and features a pass-through process chamber at the production level with all technical elements in the basement. The vertical layout improves production flow during the freeze-drying process and provides segregation of liquid and freeze-dried product states.
Located in Latina Scalo, Italy, BSP Pharmaceuticals is the largest CMO plant dedicated to the development and manufacturing of high potency and cytotoxic drugs. It offers a complete range of services to pharmaceutical companies by installing and implementing hardware and processes designed to guarantee product quality, scalability and process robustness, as well as to minimise set up times and ensure smooth and fast technology transfer and scale up processes.