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.
Sterility testing is a crucial step in aseptic manufacturing. It is a process designed to demonstrate the presence or absence of external contaminating microorganisms in substances that are intended for human use. What happens during sterility testing? Well samples of a batch are checked to verify the sterility of the entire batch. Of course it is crucial […]
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 […]
FPS has recently designed and manufactured an isolator designed to introduce up to 100kg of potent sterile API and dispense it in specific containers to be connected to the process equipment. During the initial phase of listening to the customer’s needs, the different stages of the process were analyzed, from the introduction of the material into the […]
