Our film products

Pharmaceutical packaging and cleanroom packaging made of polyethylene

Polyethylene packaging:

Packaging made of polyethylene (LDPE) is characterized by its diverse properties. It is particularly suitable for medical or pharmaceutical applications due to its ability to be sterilized.

Individually:

Thanks to their flexibility in terms of character and format, our packaging can be used for a wide range of requirements. We manufacture packaging according to your individual requirements to ensure optimal application within your processes.

Designs:
We manufacture LDPE film packaging in a wide range of designs on various cleanroom production lines:
flat film flat tube half tubing gusseted tube
film sections flat bags gusseted bags
Production formats:
Films, bags & cuts:
  • widths approx. 50 - 1,200 mm
  • thickness approx. 50 – 250 my
  • large-format packaging solutions (e.g. container covers) on request
Roll:
  • compact small rolls for manual use
  • industrial large rolls for further mechanical processing

Characteristics:
KWP cleanroom film packaging is:
  • highly pure
  • from cleanroom production ISO 14644-1, Class 5 / GMP Class B
  • with minimal bacterial contamination
  • bag-in-bag cleanroom packaging
  • transparent
  • waterproof / liquid-tight
  • flexible
  • stable
  • weldable
  • sterile or sterilizable
Sterilization:
KWP cleanroom film packaging can be sterilized using:
  • radiation sterilization (e.g. γ-radiation)
  • ethylene oxide (EtO)
  • hydrogen peroxide (H 2 O 2 )
Resistance:
KWP cleanroom film packaging is resistant to the following substances, among others:
  • alcohols
  • aliphatic hydrocarbons
  • fats
  • alkalis
  • acids
  • hydrogen peroxide

Additives:

By using additives, we can adapt the properties (e.g. slip agents to control the sliding value), handling and machinability of the films to individual areas of application.

Packaging:

Our films are always rolled on plastic cores and all products are packaged at least twice in a cleanroom-compliant manner to ensure safe inward transfer at our cutomers' facilities.

Production

Quality and precision at work - for the best result and maximum satisfaction

Cleanroom production
according to
DIN EN ISO 14644-1,
Class 5:

We are committed to producing products of outstanding quality in this strictly monitored production environment in order to meet the requirements and expectations of our customers. Your safety and satisfaction are our top priority.
All process steps, from granulate to extrusion and assembly to the finished packaged product, take place in ISO Class 5 clean rooms in accordance with DIN EN ISO 14644-1.
Our production facilities are microbiologically monitored (microbiological monitoring) and their cleanliness status is regularly confirmed.

Extrusion:

In our ISO 5 clean rooms, we produce LDPE films and film packaging on several production lines using blown film extrusion.
The particulate and microbiological status of our clean rooms corresponds to ISO Class 5 and GMP Class B.
Every step of our manufacturing process is conducted under the strictest controls to reduce the risk of contamination to a minimum.

Lock system:

Access to our production departments is via a multi-level lock system. Personnel locks and material locks are separated from each other.
This lock system ensures that our high purity classes are maintained.

Clothing:

Our packaging department is connected to the extrusion department. In this department, the previously produced films are further processed and packaged on state-of-the-art film sealing machines, for example into film bags.

Pharma set packing & aseptical workstation:

The pharmaceutical set packing of our products from the Zyto-Spezial range also takes place under conditions and in clean rooms of class ISO 5 / GMP Class B.
Particularly critical products are manufactured in separate, aseptic areas (GMP Class A/B, ISO Class 4/5) within our clean rooms.

Raw materials

LDPE – a versatile and high-quality plastic

LDPE

Low density polyethylene (LDPE) is a thermoplastic (polyolefin) with a comparatively low density, produced from ethylene by high-pressure polymerization.
LDPE is characterized by its high chemical resistance to alcohols, aliphatic hydrocarbons, fats, alkalis and acids, for example.
Due to its chemical purity - LDPE consists only of carbon and hydrogen - this plastic is completely recyclable.

Medical Grade:

In the manufacture of medical and pharmaceutical products, the raw materials used are of crucial importance. We rely on carefully selected medical-grade materials to ensure the highest standards in terms of purity, quality and safety, even in critical applications.

Our raw materials meet strict requirements set by international authorities such as the European Commission and the United States Food and Drug Administration (FDA).

The use of appropriately approved materials is an integral part of our production practices to ensure that the final products meet the highest quality and safety standards.
By consciously selecting and using these first-class raw materials, we are able to manufacture products of outstanding quality that meet the strict requirements of the medical and pharmaceutical industries. Your trust in our products is our top priority, and therefore we rely on transparency and the highest quality standards at every stage of the manufacturing process.

Approvals:
The raw materials we use comply with the following specifications:
  • Regulation EU No. 10/2011
  • Regulation EC No. 1935/2004
  • Regulation EC No. 1907/2006
  • US Food & Drug Administration (FDA) - Code of Federal Regulations
  • US Pharmacopeia (USP)
  • European Pharmacopoeia (Ph. Eur.)

*Selection

Delivery capability / risk management:

Through selective supplier selection and consistent risk management, including in procurement matters, we are able to ensure uninterrupted production and delivery capability (see > KRITIS - Critical Infrastructures).

© KWP GmbH