Building Prefilled Syringe Capacity for the Future

Demand for prefilled syringes continues to grow, reports Yves Buelens, general manager of Catalent Pharma Solutions’ (www.catalent.com) Sterile Technologies facility in Brussels, Belgium. Catalent offers a wide range of services to the pharmaceutical industry from drug development through clinical and commercial manufacturing and packaging services. Catalent processed a large number of prefilled syringes in 2009 on its three filling lines in Brussels, and the firm is poised to add a fourth line.

Yves Buelens, Catalent Pharma Solutions

“We have about 400 square meters currently as a green field in our 2600 square-meter sterile area that we could use for expansion,” says Buelens.

In addition, Catalent has just purchased a neighboring facility with about 6000 square meters, which could be used for tech transfer activity in sterile and biological product development.

Catalent’s Brussels site has a current capacity to fill 175 million 1-ml syringes each year, and that capacity was put to the test just prior to the H1N1 influenza pandemic in 2009. “Vaccine makers came to us and requested a shorter cycle time, and we reacted quickly,” explains Buelens. “Our operations are built to be very agile.”

The Brussels site can fill prefilled syringes under aseptic conditions using restricted access barrier systems (RABS) and can also terminally sterilize them using autoclave if needed. The site employs two high-speed filling lines that can handle 18,000 units/hour and a medium-speed filling line for 15,000 units/hour.

Using ready-to-fill technology from suppliers that handle syringe manufacturing, washing, siliconization, packaging, and sterilization, Catalent receives sterile syringes nested and sealed in tubs that can be put directly onto lines for filling and finishing. Use of ready-to-fill syringes in particular has helped eliminate most of the stress placed on glass syringes, Buelens explains. “With no physical contact between the syringes, there is limited cosmetic damage and very limited glass breakage,” he says. “Syringes supplied nested in tubs are more expensive, but the quality benefit is there.”

Catalent can handle all component sourcing and has worked with the following suppliers: Becton Dickinson, using its SCF (Sterile, Cleaned, and ready to Fill) syringe barrels; Bunder Glas AG, using its RTF (Ready to Fill) syringe barrels; Schott, using its 3S syringe barrels; and Nuovo Ompi. While Catalent typically specifies Type I borosilicate glass, it could work with alternative materials, such as cyclic olefin copolymer (COC), if requested. Stoppers have been sourced from Helvoet, West, Stelmi, and Daikyo.

Automatic inspection machinery is employed on the syringe-filling lines, explains Emmanuel Cajot, operations director. “Manual visual inspection can also be performed to meet certain regulatory requirements, such as those of Japan,” he adds. Four lines then handle marking, labeling, and pistoning. In May, a fully automatic line is being added. Catalent routinely adds unique identification to support clinical trial batches, says Cajot. “We have been printing 2-D Data Matrix codes for batch numbering for customers in France.”

Emmanuel Cajot, Catalent Pharma Solutions

For secondary packaging, Catalent employs automatic blister packaging lines. Catalent is currently considering upgrades and/or replacement lines to address cost improvement. “We are in the process of developing user requirement specification documents, and we are looking for suppliers that are flexible and responsive. We cannot take two years to install new equipment because of customer needs,” says Buelens.

The facility also offers management of products requiring temperature control within 2–8˚ C as well as frozen or sub-frozen products down to –70 or –80˚C. During filling and packaging processes, “we manage time out of the controlled areas and document it in batch records,” says Cajot. And, while the company maintains centralized and permanent environmental monitoring, “we can employ mobile refrigerators to decrease that time even further.”

Buelens says that Catalent’s Brussels site has been audited and found to be in compliance with requirements from FDA, European Medicines Agency (EMA), U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), Brazil’s ANVISA, Health Canada, Japan, and Australia. The facility also offers formulation, compounding, water-for-injection (WFI) diluent production, and bio tech transfer. The facility currently produces about 20 products produced for 120 countries.

Catalent’s latest project at the Brussels site includes producing a proprietary compound for Nuron Biotech for the treatment of multiple sclerosis. Catalent will formulate, fill, and package NU100 in a prefilled syringe. Nuron Biotech is currently planning to take NU100 into Phase III clinical trials in 2011.

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