West Pharmaceutical Services Inc. is adding staff and modifying production for its new ready-to-use luer-lock pre-fillable syringes and an upcoming staked needle syringe system.
Both pharmaceutical products have syringe barrels made of Crystal Zenith-brand cyclic olefin polymer instead of less-expensive glass.
The company will hire validation engineers and sterilization support staff, said Fran DeGrazio, vice president of marketing and strategic business development. The CZ programs employ 60-100 in full- and part-time positions.
The company manufactures, sterilizes and assembles the luer-lock products at its facilities in Montgomery and Jersey Shore, Pa.; and at the Sakae, Japan, plant of business affiliate Daikyo Seiko Ltd. West Pharmaceutical is targeting customers in North America and Europe, according to DeGrazio.
The company delivers a tub of syringes for direct entry into an aseptic filling line. In addition to the CZ barrel, the ready-to-use system includes a polypropylene rod, rubber-tip cap and rubber plunger.
The cap and plunger are coated with Daikyo FluroTec-brand barrier film to minimize ion-extractable emissions from the polymer and adsorption on the syringe surfaces.
Typically, a glass system uses silicone lubricants for a plunger's movement, but the silicone-oil-free CZ system avoids that need, the company said. Silicone oil may be incompatible with some protein concentrations and can degrade the effectiveness of a drug.
West Pharmaceutical introduced the pre-fillable syringes at the April Interpack show in Dusseldorf, Germany.
``Customers and the pharmaceutical industry are becoming more familiar with the [ready-to-use] CZ product and are asking for proprietary containers for specific programs,'' DeGrazio said in a telephone interview from company headquarters in Lionville, Pa.
Separate development work on the insert-molded staked needle syringe due on the market in 2009 takes place at Daikyo and in Scottsdale, Ariz., at Tech Group, a West Pharmaceutical business segment.
The Food and Drug Administration must approve any drug application that uses a new Daikyo CZ syringe system for delivery of a drug product.
The drug applicant is responsible to assure that the drug in the syringe meets applicable drug stability criteria, DeGrazio said. The characteristics of the CZ syringe can help sensitive biopharmaceuticals achieve this requirement due to its inertness, he added.
Nippon Zeon Co. Ltd. of Tokyo manufactures the CZ-brand COP resin and, in 1995, granted Daikyo and West exclusive global rights to use it in pharmaceutical and medical devices.
In addition to the pre-fillable system, Daikyo also manufactures containers and vials produced from the same CZ resin.
DeGrazio withheld volume data but said Daikyo in Japan has doubled its manufacturing capacity for CZ products.