Polyethylene films for the pharmaceutical industry
Cleanroom-made, chemically neutral, traceable packaging film for the strictest cleanliness requirements of pharma and medical technology.
What pharma expects from packaging
Four requirements every QA team checks at every supplier — and our answer to each.
Cleanliness
Minimal particle count on the film surface: contamination is a risk to sterile products and medical devices.
Chemical neutrality
The packaging must not interact with the contents: migration-free, odour-free PE is required.
Traceability
LOT number, date and product information on the packaging — industry regulation requires it.
Antistatic protection
Electronic diagnostic devices, implants and measuring instruments are ESD-sensitive.
How cleanroom film is made
Four steps in a controlled environment — every step documented.
- 1
Raw material
LDPE/LLDPE pellets, closed material handling, minimal human contact.
- 2
Extrusion
3-layer co-extrusion inside the ISO Class 9-compatible cleanroom, in filtered air.
- 3
Converting
Tubing, bags, pouches — cutting and sealing in the controlled environment.
- 4
Identification and packing
Per-roll ID and production date; the finished roll is packed inside the cleanroom.
Where does ISO Class 9 sit on the cleanliness scale?
ISO 14644-1: permitted particles (≥0.5 µm) per cubic metre, by class.
Our cleanroom is not certified: it operates and is measured to ISO 14644-1 Class 9 — the measured value is a fraction of the Class 9 limit.
Our solutions for pharma
Cleanroom film
Polyethylene film made in an ISO 14644-1 Class 9-compatible cleanroom. Low particle contamination, 3-layer co-extrusion, LDPE/LLDPE, 20–200 µm.
Details
ESD film for medical devices
Antistatic film for packaging diagnostic equipment, implant electronics and sensor instruments. 10⁹–10¹² Ω surface resistance.
Details
Printed packaging
Flexo-printed LOT number, expiry date, barcode and product information on the film. Up to 6 colours.
DetailsOur products for pharma
All can also be made in the cleanroom — size and formulation tailored to the application.
Typical applications
- Secondary packaging of pharmaceutical raw materials (tubing, bags)
- Protective packaging of medical devices (diagnostics, sensor instruments)
- Outer packaging of implants and sterile instruments
- Packaging of laboratory consumables
- Temporary covering of cleanroom furniture and equipment
Why Parainesis?
ISO Class 9-compatible cleanroom
A dedicated production line for the highest cleanliness requirements.
Traceability
Every roll carries an ID number and production date.
Custom development
Formulation and configuration tailored to your application.
Experience
30+ years of industrial film production, references from the pharma sector.
Certified management systems
The company's quality, environmental and safety management systems are certified: ISO 9001 · ISO 14001 · ISO 45001 (downloadable in the footer). The cleanroom is ISO 14644-1 Class 9-compatible, not certified.
Technical summary
Next steps
Looking for cleanroom-compatible packaging film? Send us the ISO class, the application and the sizes — our experts reply within 24 hours.
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