Polyethylene (HDPE)

PE is the most common term for polyethylene. It is a plastic material that tolerates irradiation (gamma and e-beam), which means that the packaging is suitable for aseptic filling – ready to use. However, the formulation always determines the type of packaging. A plastic vial made of high-density polyethylene plastic is not suitable for autoclaving.

For production of vials in PE plastic we only use high-density polyethylene plastic (HDPE). It is made from medical grade virgin-material and meets all regulations cf. European Pharmacopoeia (Ph. Eur.) and US Pharmacopoeia (USP). In addition, a DMF is available on the material.

Vials are packed in clean room ISO Class 7

All HDPE vials are packed in our clean room ISO class 7 / EU-GMP class C. This room is established according to the EU-directives 91/356 EØF and 91/412 EØF and meet all current guidelines.

The air of the clean room is automatically controlled and the monitoring and alarm system functions 24 hours a day, enabling immediate intervention if disruptions arise.

Bacteriological control and control of particles are performed regularly by an external company to ensure that the system works.

HDPE vials can be used to contain e.g.:

• Fish vaccine
• Hydrogen Peroxide
• Iron Dextrane
• Iron Preparation
• Macrogol 400
• Vaccine for foot and mouth disease

If you want to know if HDPE vials are suitable for storage of your liquid, our development department is always ready to help you - contact us here.

Vials made from polyethylene plastic

• Are blown by sterile filtered air
• Are packed in clean room ISO class 7 / EU-GMP class C
• Are pressure-tested on the machine
• Are quality-tested by use of sampling at least every 3 hours
• Are examined for particles
• Are being bacteriologically tested
• Are compatible with standard rubber stoppers and aluminium caps according to ISO 8362 and ISO 8536
• Are Ready-to-Use -suitable for aseptic filling
• Have high impact strength
• Provide a safer working environment
• Medical Device Manual is available, which is very useful at registration. The NDA must be signed upon delivery.