Rhein-Plast is a company in the Industrial Packaging Liner industry

+49 6322 7980

Industries

PRODUCTS

Applications

Quality

Primary packaging

GMP-compliant primary packaging directly from the manufacturer

We produce high-purity PE bags and films for direct contact with pharmaceutical active ingredients and products. Manufactured in a cleanroom, can be validated and tailored to your processes.

ISO 9001

GMP-compliant

Cleanroom ISO 5/7/8

Antistatic available

Product overview

What are primary packaging materials?

Product overview

What are primary packaging materials?

Primary packaging materials are in direct contact with the pharmaceutical product. Rhein-Plast manufactures high-quality PE primary packaging materials in ISO-certified cleanrooms. They meet the requirements of the European Pharmacopoeia and FDA guidelines, offer excellent chemical resistance, low extractables/leachables values, and are fully validatable.

At a glance

Pharma-grade PE

Cleanroom ISO 5/7/8

Ph. Eur. / FDA

Low E&L values

Fully verifiable

Gamma-sterilisable

At a glance

Pharma-grade PE

Cleanroom ISO 5/7/8

Ph. Eur. / FDA

Low E&L values

Fully verifiable

Gamma-sterilisable

TECHNICAL DETAILS

Characteristics and specifications of our primary packaging

Qualified for direct contact with medicinal products

Material

High-purity PE film (LDPE/HDPE), in-house extrusion

Manufacturing

Cleanroom ISO 5, 7, 8

Conformity

GMP, Ph. Eur., FDA 21 CFR 177

Sterilisation

Gamma, EtO possible

E&L

Extractables/Leachables data available

Sizes

Custom-made according to customer specifications

Material

High-purity PE film (LDPE/HDPE), in-house extrusion

Manufacturing

Cleanroom ISO 5, 7, 8

Conformity

GMP, Ph. Eur., FDA 21 CFR 177

Sterilisation

Gamma, EtO possible

E&L

Extractables/Leachables data available

Sizes

Custom-made according to customer specifications

Become our development partner

Together we develop the optimal solution for your product contact.

CONFIGURATION

Tailored solutions for your product contact

From standard to highly specialised

Standard PE bag

Proven bags for direct product contact in pharmaceutical production

Standard

PE

GMP

Sterile primary packaging

Gamma-sterilised for aseptic filling and sensitive formulations

Sterile

Asepsis

Gamma

Special film bags

Barrier or antistatic films for special requirements

DÜPOLEX®

Barrier

Special

Standard PE bag

Proven bags for direct product contact in pharmaceutical production

Standard

PE

GMP

Special film bags

Barrier or antistatic films for special requirements

DÜPOLEX®

Barrier

Special

Sterile primary packaging

Gamma-sterilised for aseptic filling and sensitive formulations

Sterile

Asepsis

Gamma

Additional configuration options

Different film thicknesses, weld seams and closure options, custom-made to suit your process.

Areas of application

Typical areas of use

Wherever there is direct product contact

Medicine packaging

Bags and films for direct contact with the active ingredient

Aseptic filling

Sterile packaging for sensitive formulations

API caching

Safe storage of active substances and intermediates

Biotech products

Primary packaging for biological active substances

Medicine packaging

Bags and films for direct contact with the active ingredient

API caching

Safe storage of active substances and intermediates

Aseptic filling

Sterile packaging for sensitive formulations

Biotech products

Primary packaging for biological active substances

Industries

Qualified for regulated industries

Pharma, biotech and medical technology in focus

Pharma
Biotech
Medical technology

Products

Contact us – we’ll be happy to advise you

Contact us –
we’ll be happy to advise you

Talk to our experts about your specific requirements for

containment systems and primary packaging.