A New Concept in Aseptic Filling: Closed-Vial Technology

The closed vial has been developed to improve aseptic filling quality and to reduce process complexity. A ready-to-fill closed vial consists of a sterile vial provided with the stopper secured in place. The vial is filled by inserting a noncoring needle through the stopper, which is then resealed by laser.

Aseptic filling has been well establ i s h ed for several dec ades but regulatory requirements have become more and more re s tri ctive over ti m e . For ex a m p l e , aut h ori ties have requ ested incre a s ed envi ronmental safety in the filling area, with very stri ct requ i rem ents rega rding el i m i n a ting po ten tial con t a m i n a ti on agents and reducing particles, in ad d i ti on to revising product formu l a ti ons to el i m i n a te pre s erva tive s . These recommendati ons have led to two major improvem en t s : bet ter air qu a l i ty control to redu ce con t a m i n a ti onrisk and new cont ainer de s i gn s . Containment tech n o l ogies reduce the risks associated with the human pre s ence in Class 100 cl e a n rooms. The isolator appe a rs to be the best soluti on in terms of quality, a l t h o u gh it is the most com p l ex for ph a rm aceutical manu f actu ri n g, e s pec i a lly for condu cting mu l tiple and difficult validati on ex periments, performing controlled va por-phase hydrogen peroxide sterilization, maintaining del i c a te pre s su re balance s , and con tro lling the complex airf l ow patterns gen era ted in the cl o s ed envi ronment.

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