Sterile API production is possible whenever a sterile environment can be assured during all production steps. Full understanding and integration of all manufacturing steps are necessary to obtain the desired results.
Isolation technology maintains the sterile environment around the process with minimal space requirements.
FPS designs isolators for the following API manufacturing processes:
More and more HPAPIs are requested to be manufactured under sterile conditions.
The requirements for sterile manufacturing and operator safety and protection can be met by custom designed isolators.
FPS and Amira: a strategic partnership allowing high quality standard for the biodecontamination of sterile isolators.Discover more reading the article on May issue of NCF magazine (Italian version attached). Courtesy translation.
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 […]
Last week we asked our followers: Can an isolator handle an API that is both potent and sterile? Let us explain. If a powder is both sterile and toxic, the isolator will start working under sterile conditions. A VHP cycle will be run and the isolator will operate under positive pressure to keep the aseptic conditions (i.e. prevent […]
Process: The multi-chamber isolator is designed to guarantee a sterile environment for the micronization of up to 20kg of API with a PilotMill-6 spiral jet mill. Process steps: Introduce material in the micronization chamber Run a decontamination cycle for the working chambers and a sterilization cycle for the micronization unit Open the bags and charge […]
