Plastic vials, jars, ampoules in HDPE, COC/COP high barrier

ClearVial™

Vials made of COC or COP is a transparent alternative to a glass vial.

With our 100 % transparent ClearVials, we introduce a pharmaceutical plastic packaging, which alone by its size, lightweight and impact strength represents a ground-breaking packaging solution for the biotech and pharmaceutical industry.

Our transparent ClearVials are manufactured from COC plastic (Cyclic Olefin Copolymer) and COP plastic (Cyclic Olefin Polymer).
It is a completely transparent material that allows you to inspect the vial fluid for particles during the production process and before use.

COC and COP vials can be delivered Ready-to-Use

Both our COC and COP plastic vials can be delivered sterile and Ready-to-Use. The vials are therefore suitable for aseptic filling.
It is neither necessary to wash or dry the vials before filling, making ClearVial a very profitable choice as it is not necessary to implement a washing and drying plant in your production line.

Depending on your current production line, you reduce both your consumption of water and electricity while reducing your production time.
And because our ClearVials follow  ISO standards, they are identical to a glass vial. It is therefore easy to implement COC or COP vials in your existing production line without major investments.

Transparent vials replace glass and increase your flexibility

Compared to glass, COC and COP favours the environment both with regards to transport, filling and disposal. A Drug Master File (DMF) is available for both materials and meet all regulations cf. European Pharmacopoeia (Ph. Eur.) and US Pharmacopoeia (USP).

However, when choosing a pharmaceutical plastic packaging – a ClearVial – you are not bound to standard sizes. In cases where our standard sizes and designs do not meet your unique needs, we would like to collaborate on a customised solution with a high flexibility both in terms of order sizes, special packing requirements and delivery.

Features and Benefits

• Are blown by use of sterile filtered air
• Are packed in clean room ISO class 7 / EU-GMP class C
• Are pressure tested on the machine
• Are being quality-tested by use of test samples every third hour as a minimum
• Are being examined for particles
• Are bacteriological and endotoxin tested
• Are pyrogen-free
• Comply to ISO-standard 8362, which means that it is identical to a type-I glass vial
• Can be delivered Ready-to-Use – no wash needed before filling
• Have good barrier properties
• Are suitable for autoclaving at 121° C/250° F for 15 minutes
• Come in sterile state (gamma-irradiated)
• Are cold and heat resistant
• Are 100 % transparent, enabling easy identification of fluid particles
• High impact strength
• Provide a safer work environment
• Medical Device Manual is available, which is very useful at registration. NDA must be signed at handover
• Drug Master file is availab

Polypropylene Containers (PP)

A vial with unique barrier properties

Polypropylene plastic (PP) is used for plastic packaging in the pharmaceutical industry. Our vials made of polypropylene come in 10 different standard sizes from 3 ml up to 1000 ml.

The vials are made from virgin medical grade polypropylene plastic, which comply with the regulations in European Pharmacopoeia (Ph. Eur.) and US Pharmacopoeia (USP). A Drug Master File is furthermore available for the material and for the vials. The vials are available in the colours natural and amber-dyed. The amber-dyed version is used for light sensitive fluids as for instance some oncological products.

Vials in polypropylene can be autoclaved at 121° C / 250° F. If you need a pre-sterilised vial in PP plastic, please contact us for further information.

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.

Features and Benefits

• 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.

Polyethylene Containers (PE)

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.

Features and Benefits

• 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.

Multilayer Containers

Multilayer vials with unique barrier properties protecting against e.g. oxygen and other gases.

At MedicoPack, we have many years of experience and expertise within the development and production of multilayer vials.  We manufacture more than 4 million multilayer vials annually, the majority of which is customised designs.

As a rule, our multilayer vials are based on a PP/EVOH/PP construction. EVOH is an ethylene-vinyl alcohol-based material. EVOH increases durability and ensures the integrity of the pharmaceutical product in the best manner possible. In addition, multilayer vials normally come irradiated thus they are suitable for aseptic filling.

The combination means that the barrier properties of the vials are significantly increased which makes it suitable for e.g. oxygen-sensible products. The multilayer vial exploits the barrier properties of both PP and EVOH. The barrier layer furthermore protects fat and vitamin containing products against oxidation.

The materials meet the strictest requirements from the authorities regarding medical primary packaging and have all been approved according to US Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.).

When durability counts!

Medical products become more complex, which imposes more stringent requirements on the packaging’s barrier properties. Modern medical products are often volatile and sensitive to oxygen, so it may be a problem to obtain the necessary shelf life if the product is filled into a monolayer PP, HDPE or COC vial.

As a solution to this particular problem, MedicoPack offers multilayer vials. These are vials made up of a PP / EVOH / PP construction. It is a unique construction that gives the product a longer durability, as the EVOH material provides a functional barrier in both directions: it ensures formal integrity and quality, while also blocking external gas penetration.

Multilayer plastic packaging

• Is much cheaper than coated glass vials
• Can be designed with different barriers, up to 6 layers of plastic
• Is blown by sterile filtered air
• Is pressure tested on the machine
• Is quality tested by use of sampling at least every 3 hours
• Is examined for particles
• Is bacteriologically tested
• The vials are compatible with standard rubber stoppers and aluminium caps according to ISO 8362 and 8536
• High impact strength – minimal risk of vials breaking on the filling line, during use and during transport
• Can be delivered irradiated
• Suitable for autoclaving at 121 ° C / 250 ° F for 15 minutes – autoclave guide can be sent.