A platform process is producing a suitable process for the manufacture of a group of related products in a defined generation system. At Lonza one of our technology platform offerings is a process for the manufacture of therapeutic proteins in Chinese hamster ovary (CHO) cells.
Container closure integrity plays an significant role in Maintaining the sterility and stability of lyophilised sterile products. Defects qui cause has freeze dried vial to leak are not Necessarily detected by a visual inspection process. Such defects are examples of microscopic cracks in the glass & scratches, defects That are hidden by the crimp, or temporary defects Such As That stop pop-up result in temporary container leakage.
Increasingly, 100% automated container closure integrity testing (CCIT) is Being Implemented to complement visual inspection for ontrolling the quality of finished products sterile vial.
Freeze dryers equipped with 100% environmentally friendly refrigeration system: AIR -> REFRIGERANT (The Wave 47)
Since 20 years, refrigerants, used in the production of cold, regularly subject to restrictive regulatory measures at European level, in order to limit their environmental impact. The F-Gas Regulation has been further amended, particularly involving a drastic reduction of fluorinated gases with high impact on global warming.
To ensure the quality and sterility of the end product of a BFS process, it is not limited to one machine. The articulated around environment, and allowing its operation is also to be considered. To develop the implementation strategy (engineering) and validation (quality assurance), we must identify, integrate and control the critical points related to the process.
Rationalize and prioritize the control provisions of the manufacture of a medicament: this is the aim of the Quality Risk Management (QRM). Although the background, the approach by the risk is a methodology used and operated for a long time in other industries, for pharmaceutical companies, because of their public health mission, the implementation is much more delicate.