Sterile API production is possible whenever a sterile environment can be maintained throughout all stages of the manufacturing process. A full understanding and proper integration of all manufacturing steps are essential to achieving the desired results.
Isolation technology helps maintain a sterile environment around the process while minimizing space requirements.
FPS Pharma engineers isolators for the API manufacturing processes:
An increasing number of HPAPIs are now required to be manufactured under sterile conditions.
The requirements for sterile manufacturing, as well as operator safety and protection, can be met through custom-designed isolation systems.
One of the most important projects of this year has been the construction of a production scale sterile contained micronisation system that was delivered to a pharmaceutical manufacturer in Spain last July. The equipment, designed to be installed across different floors, is composed of a glovebox to discharge the batches from a filter dryer without affecting the […]
FPS has recently delivered a high containment Integrated systems for an Oncology plant in Bangalore. The system is composed by an ANFD discharge Isolator, a Vacuum Transport System (VTS) and a Micronization equipment PROMILL-8 in Isolator. “Our client searched an appropriate solution for -grinding material and clean packaging after the filtering and drying process-“ say […]
The experience gained in 16 years of activity allows FPS to be a world leader and offer a service with high-quality standards for the global market. The design and production process of the systems is carried out entirely in the plants of Fiorenzuola d’Arda (PC), starting from a careful listening of the customer’s requests to […]
FPS present the Toxic-sterile Isolator for preparation vessel charging How to weight and dispense a HIGH POTENT STERILE into a process vessel? How to maintain the API sterility and protect the operator without using PPE? How to avoid cross contamination from processing different products? Process: Weight & charge a HPAPI into a process vessel in […]
