To address the incidents that are still recorded each year due to the injection of contaminated products, and the complexities of vial component preparation, high-speed stoppering, and aluminum cap crimping, Aseptic Technologies, a subsidiary of GlaxoSmithKline Biologicals, developed the new Crystal® Closed Vial technology for aseptic filling of injectable products.
This new technology consists of a read-to-fill vial which is supplied clean and sterile to the pharmaceutical manufacturer. To obtain a clean and sterile vial, both vial body, made of cyclo-olefin copolymer (COC), and thermoplastic elastomer (TPE) stopper are molded in clean room Class 100 / Grade A / ISO 5 clean room and directly assembled by robot. To ensure sterility, the container is gamma-irradiated prior to delivery to the pharmaceutical manufacturer.
The filling process of this ready-to-fill container consists of a needle piercing the stopper and dispensing the liquid. After needle withdrawal, to restore closure integrity, the piercing trace is laser re-sealed. A cap, with the stopper surface protected until use by the doctor, is placed by snap fit. All these operations are performed inside a Closed Vial Filling System (CVFS) which ensure a permanent Class 100 / Grade A / ISO 5 environment around filling operations. All classical vial and stopper preparation steps (washing, siliconization and sterilization) have been eliminated.
As this technology was completely new, Aseptic Technologies decided to install the first Crystal Closed Vial Filling Line (CVFL) in its own Gembloux, Belgium facility and operate it as a contract manufacturing organization to help clients obtain stability data and fill clinical batches before making large financial investments.
The major advantages of this new technology are a better sterility assurance level (SAL) for the patient and a simplification of the overall process. The SAL is improved by keeping the vial permanently closed, the vial behaving as an isolator by itself. This simplification affects the entire supply chain including the manufacturing (simplified process with elimination of large quantity WFI generation, sterilization, high speed stoppering and aluminum cap crimping), transportation and storage (unbreakable and secured container). Healthcare practitioners have also largely expressed their preference for the closed vial in view of its ease of use (easy to open, to pierce and to collect the liquid), its resistance to shocks and the improvement of the asepsis.
The site is located in the center of Europe, 60 km away from Brussels, the capital of Belgium and European Community. It is composed of two buildings: AT01 which is dedicated to offices meeting rooms and workshops and AT02 that includes workshop, offices and a filling suite of 400-square-meters with all of the necessary equipment to perform aseptic filling in the Crystal Closed Vial technology.