The world's number two manufacturer of rubber components for pharmaceutical products, Helvoet Pharma, has broken ground on a new facility that promises to double or even triple its capacity to supply the fast-growing markets for injectable biologics and cancer drugs.
Belgium-based Helvoet is already a major player in the market for rubber components such as the stoppers for vials, and other elements such as plungers and tip caps used in syringes and insulin cartridges, ranking in the market somewhere behind West Pharma Services of the US and ahead of France-headquartered Stelmi.
The company said the new facility, one of five it operates around the globe, would keep it among the top players in the sector in supplying the fast-growing market for components used in biologics, vaccines and oncologics.
The sensitive nature of these drugs means that considerable care has to be taken in selecting rubber components. Selecting a poor grade of stopper, for example, could allow leaching of elements into the vial that inactivate its contents, according to Helvoet's marketing manager Paul Roosen.
The new facility, which will take up 6,000 square metres, should add 500 million to 1 billion extra units to Helvoet's current output of 'several hundred million' vial stoppers that are destined for these fragile products, said Roosen, who also noted that the firm's total output of stoppers is in the region of 12 billion a year.
The main products made at the facility will be Helvoet's FM457 range of stoppers, made of an inert elastomer that has been specifically designed to prevent leaching and so be suitable for filling sensitive drugs, as well as the firm's Omniflex and Omniflex Plus ranges. The latter are said to be unique in the marketplace and are coated with an impermeable barrier to prevent leaching.
Both products are important items for biologic and other fragile drugs - the Omniflex range is a little more expensive but can shorten time to market by making stability testing easier. Meanwhile, the FM457 range is suitable for sterilisation via gamma irradiation, an important factor in the production of ready-for-use (RFU) injectable products.
Other product lines destined for the new facility include Helvoet's FM460 range of low-moisture stoppers and pre-filled syringe components (FM480).
Roosen told in-PharmTechnologist.com that the new facility will allow it to carry out almost the entire production process - from pressing the mixed rubber into moulds through die cutting, washing/sterilising and packaging into RFU or ready-for-sterilisation (RFS) units - in a cleanroom environment. At the moment only the washing, sterilisation and packaging stages are carried out in cleanrooms.
"Large companies want suppliers to uphold the same strict standards in their manufacturing processes as applied to the pharmaceutical sector itself," he said, adding that the plant - which represents an investment to the tune of €22m, should be operational by January 2009.
Helvoet also makes aluminium crimp seals for cartridges and aluminium seals and flip caps for vials and operates plants in Alkan, Belgium, Italy, the US and Germany.