Polypropylen (PP)

Vials packed in clean room ISO Class 7

All PP vials are packed in our clean room ISO class 7 / EU-GMP class C. This room is constructed according to EU-directives 91/356 EØF and 91/412 EØF and comply with 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.

PP vial can be used to contain e.g.:

• Adrenaline
• Glucose
• Radioactive Isotopes
• NaCl solutions
• Lidocaine
• Cisplatin
• Potassium
• Sterile water
  
  If you want to know if PP vials are suitable for storage of your liquid, our development department is always ready to help you - contact us here.

Vials made from polypropylene plastic as packaging

• 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 test samples every third hour as a minimum
• Are examined for particles.
• Are bacteriologically tested.
• The vials are compatible with standard-rubber stoppers and aluminium caps cf.  ISO 8362 and ISO 8536
• High impact strength - minimal risk of  breaking vials on the filling line, during use and transport.
• Suitable for autoclaving at 121° C/250° F for 15 minutes – autoclave guide can be sent.
• Medical Device Manual is available, which is very useful at registration. NDA must be signed at handover.
• Drug Master File is available.