Log in | Register

Aseptic Technologies / Facility of the Year Award Winner - Equipment Innovation

For the latest pharmaceutical news and updates - Sign up now!
Loading...
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.

Register or log in to send e-mail for more info

E-mail to a colleague

See company's other products

Pharmaceutical Processing

Blogs

When Is Software The Answer To Regulatory Concerns About Your Investigations?

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Jan 30 | John Ager, Technical Consultant, Life Science, Kepner-Tregoe, Inc

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.

The Benefits of Professional Project Management

The Benefits of Professional Project Management

Jan 13 | Thorsten Vammen, Director at GEA Liquid Processing in Skanderborg, Denmark

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.

Multimedia

Government Seeking $1T Campaign Against Alzheimer's

Government Seeking $1T Campaign Against Alzheimer's

Jan 18 | Video

Government advisors tried to set priorities for a national campaign to treat and manage Alzheimer's disease, which is projected to cost more than a trillion dollars in care by 2050. But as Dr. Jon LaPook reports, the plan does not include any funding.

ADHD Drugs in Short Supply

ADHD Drugs in Short Supply

Jan 11 | Video

Parents of children with attention deficit disorders are forced to travel from pharmacy to pharmacy in search of prescription medicines with no guarantees they will be available.

Study: Link Between Statins And Diabetes

Study: Link Between Statins And Diabetes

Jan 10 | Video

A recent study reveals that women who take statins may have a greate chance of developing diabetes.

Avastin Shows Promise in Fight Against Ovarian Cancer

Avastin Shows Promise in Fight Against Ovarian Cancer

Jan 5 | Video

Two recent studies show that Avastin, already approved for other cancers - but still controversial, could help women buy more time in their fight against ovarian cancer.

Top Stories and Headlines
EVERY DAY!

FREE Email Newsletter