Helvoet Pharma - Rubber Closures and Aluminium Caps for Injectable Drugs and Medical Devices

Helvoet Pharma, the pharmaceutical packaging division of the Dätwyler holding, is a leading manufacturer of rubber closures and aluminium caps for injectable drugs, medical devices and diagnostic systems.

Helvoet Pharma has five rubber manufacturing plants and four plants for the production of aluminium seals and flip-caps spread around Europe and the US. All together, more than 12 billion components are supplied to a global customer base. This makes Helvoet Pharma a key supplier to the pharmaceutical, biotech, medical device and diagnostic markets worldwide.

COMPONENTS FOR PREFILLED SYRINGES

An extensive product range of components for prefilled syringes enables Helvoet Pharma to be a leading supplier in this field. Helvoet Pharma’s product range includes plungers, pistons and tip caps, coated (OCP) or uncoated, next to latex and MBT-free compounds, such as FM27, for needle sleeves or needle covers.

OMNIFLEX PLUS - COATED RUBBER CLOSURES

OmniflexPlus is an inert, flexible, fluorinated polymer coating for pharmaceutical rubber closures that covers the entire product surface, including the trim edge. The chemical inertness of the fluorinated polymer coating provides a very high degree of compatibility with pharmaceutical or biotechnology products.

OmniflexPlus coated stoppers offer the excellent seal integrity of the vial-closure combination. OmniflexPlus coated stoppers can be supplied gamma sterilised.

The absence of siliconisation makes OmniflexPlus stoppers a key component for Biotech applications, cephalosporines, cytostatics and other high-end pharmaceutical product developments.

RUBBER-FREE AND LATEX-FREE COMPOUNDS

If you are looking for the compound with the lowest extractables level available in the market, Helvoet Pharma can comply with the FM457 rubber compound. This compound is available for stoppers and for components for prefilled syringes. Excellent gamma-irradiation resistance and the fact that this compound is extremely compatible with Water for Injection (WFI) are two of the benefits of FM457.

If demanding lyophilization applications are involved, FM460 is the answer. FM460 is the newest low moisture compound for universal use.

All these compounds are free from latex and natural rubber. They also comply with all major pharmacopoeial requirements

READY-FOR-STERILISATION AND READY-TO-USE COMPONENTS

Helvoet Pharma can supply its products as Ready For Sterilisation (RFS) or Ready To Use (RTU). In both cases the products are washed with purified water and rinsed with water for injection. When using RFS components, a very high standard of particulate and biological cleanliness is applied. The products are packed in special autoclavable bags. The main advantage is that Helvoet Pharma’s customers do not need to wash and repack goods before the sterilisation process in the autoclave saving time and money.

RTU products are a step beyond RFS. Components are supplied gamma-irradiated and can be used immediately in the clean room without pre-treatment.

Both RFS and RTU are based upon validated processes.

RFS AND RTU ISOLATORS

Helvoet Pharma can also provide the components for use in isolaters in Ready for Sterilization or Ready to Use forms. In order to enable this, the components are supplied with a Rapid Transfer Port (RTP) connection.