Recent years have shown steady growth in manufacturing sterile, high potent products in the pharmaceutical industry. Antibiotics for intravenous or intramuscular injection in powder form such as Ceftriaxone Sodium for example, need to be produced under sterile conditions.
It is therefore critical to fully understand all safety aspects and to have access to specialized technology and expertise. The selection of the proper technical solutions can address and overcome the regulatory and process related challenges and improve pharmaceutical plant operations.
From the drying process to the final packaging of the material it is of the upmost importance to handle the powders without exposure to the environment or human contact.
Authorities have found noncompliant facilities using open aseptic processing systems (including open RABS). As they were not able to ensure consistent contamination prevention and thereby presenting a major and persistent risk of sporadic contamination, they are strongly recommending to have a fully closed operation under strict control conditions.
Dec has developed unique concepts to link the various process steps in a closed way combined with isolator technology thus eliminating any risk of product exposure and therefore guaranteeing fully compliant manufacturing facilities along with optimized production cost.