Helvoet Pharma, the pharmaceutical packaging division of the Daetwyler holding, is a leading manufacturer of rubber closures and aluminium caps for injectable drugs, medical devices and diagnostic systems.
Helvoet Pharma has a global presence through the different production locations, geographically spread in the world. Helvoet Pharma has 5 rubber manufacturing plants and 4 plants for the production of aluminium seals and flip caps in Europe and the US. All together, more than 12 billion components are supplied to a global customer base. This makes Helvoet Pharma a worldwide key supplier to the pharmaceutical, biotech, medical device and diagnostic market.
Components for prefilled syringes
The 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.
OmniflexPlus
OmniflexPlus is an inert, flexible, fluorinated polymer coating for pharmaceutical rubber closures which 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. Next to this, OmniflexPlus coated stoppers offer an excellent seal integrity of the |
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vial-closure combination. OmniflexPlus coated stoppers can be supplied gamma sterilized. (Ready-for-Use) The absence of siliconisation makes OmniflexPlus stoppers the key component for Biotech applications, Cephalosporines, Cytostatics and other high end pharmaceutical product developments.
Compounds
If you are looking for the compound with the lowest extractables level available in the market, Helvoet Pharma can comply with rubber compound FM457. This compound is available for stoppers and for components for prefilled syringes. An additional advantage comes from the excellent gamma-irradiation resistance and the fact that this compound is extremely compatible with Water for Injection (WFI).
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, and are complying with all major pharmacopoeial requirements
Ready-for-Sterilization or Ready-for-Use?
Helvoet Pharma supplies to its customers products in RFS or RFU. 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 customer do not need to wash and |
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customer do not need to wash and repack goods before the sterilization process in the autoclave. Time and money are saved as a result of this solution. One step beyond RFS is RFU, where components are supplied gamma-irradiated. Components can be used immediately in the clean room without pre-treatment. Both RFS and RFU are based upon validated processes.
Isolators
Helvoet Pharma can also provide the components in Ready-for-Sterilization or Ready-for-Use for use in Isolators. In order to enable this the components are supplied with RTP-connection. (Rapid Transfer Port)
Flip Caps
At Helvoet Pharma we manufacture a wide range of plain aluminum caps, flip caps and caps for IV packaging. The different aluminum colors, plastic buttons and configurations make Helvoet Pharma one of the market leaders in secondary packaging for injectable drugs. Our aim is to provide high qualitative aluminum seals and flip caps with a multi-functional target :
. Protect the drug from outside contamination
. Protect the injection site of the rubber closure
. Maintain the seal integrity of the vial and closure
. Differentiate vials with different content
. Increase tamper evidence
Helvoet Pharma can offer these caps in all standard sizes. |
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