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Industry solution

Polyethylene films for the pharmaceutical industry

Cleanroom-made, chemically neutral, traceable packaging film for the strictest cleanliness requirements of pharma and medical technology.

ISO Class 9
compatible cleanroom line (operates to ISO 14644-1)
20–200 µm
cleanroom film thickness
3 layers
co-extrusion, uniform quality
30+ years
industrial film production

What pharma expects from packaging

Four requirements every QA team checks at every supplier — and our answer to each.

01

Cleanliness

Minimal particle count on the film surface: contamination is a risk to sterile products and medical devices.

Our answerProduction in an ISO Class 9-compatible cleanroom with filtered air, controlled temperature and positive pressure.
02

Chemical neutrality

The packaging must not interact with the contents: migration-free, odour-free PE is required.

Our answerLDPE/LLDPE raw material, custom formulation tailored to your application.
03

Traceability

LOT number, date and product information on the packaging — industry regulation requires it.

Our answerEvery roll carries an ID and production date; flexo printing in up to 6 colours.
04

Antistatic protection

Electronic diagnostic devices, implants and measuring instruments are ESD-sensitive.

Our answerESD film, also in a cleanroom-compatible version.

How cleanroom film is made

Four steps in a controlled environment — every step documented.

  1. 1

    Raw material

    LDPE/LLDPE pellets, closed material handling, minimal human contact.

  2. 2

    Extrusion

    3-layer co-extrusion inside the ISO Class 9-compatible cleanroom, in filtered air.

  3. 3

    Converting

    Tubing, bags, pouches — cutting and sealing in the controlled environment.

  4. 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.

ISO 3ISO 4ISO 5ISO 6ISO 7ISO 8ISO 9Parainesis (Class 9-compatible)measured: ~400,000 / m³limit: 35,200,000 / m³

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

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

ESD film for medical devices

Antistatic film for packaging diagnostic equipment, implant electronics and sensor instruments, to your technical requirements.

Details
Printed packaging

Printed packaging

Flexo-printed LOT number, expiry date, barcode and product information on the film. Up to 6 colours.

Details

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
Gowning station before the cleanroom: white coats and protective shoesBlown film line with stairs and winder in the cleanroom

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.

ISO 9001ISO 14001ISO 45001

Technical summary

Parameter
Value
Cleanroom
ISO 14644-1 Class 9 (compatible, not certified)
Raw material
LDPE / LLDPE
Structure
3-layer co-extruded or mono
Thickness (cleanroom film)
20–200 µm
Width
90–2800 mm (gusseted tubing: 3100 mm)
ESD surface resistance
to your technical requirements
Printing
flexo, up to 6 colours
Identification
per-roll ID + production date

Next steps

1

Sample request

Send a short specification and we post a free sample within 48 hours.

2

Technical consultation

Let's discuss the optimal formulation and size for your application.

3

Quotation

A tailored quotation within 24 hours.

Looking for cleanroom-compatible packaging film? Send us the ISO class, the application and the sizes — our experts reply within 24 hours.

Get a quote