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

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Asepsis

Primary packaging materials and containment for aseptic processes

Sterile barriers, validatable systems and regulatory certainty for aseptic manufacturing processes in the pharmaceutical and biotech industries.

Asepsis

Sterile

cleanroom

GMP

Overview

Eliminate contamination by design

Aseptic processes are at the heart of sterile manufacturing in pharmaceuticals and biotechnology. To ensure patient safety and the integrity of the product, every source of contamination must be eliminated. This requires complete control over all product-contact surfaces and materials. Our GMP-compliant packaging and containment systems are therefore not just passive enclosures, but active, integral components of your validated process. They secure the sterile barrier and enable safe handling of active substances and components under the highest cleanroom conditions.

challenges

Critical requirements in aseptic manufacturing

Sterile integrity and low particle contamination

Each component must be low in particles and form a verifiable sterile barrier to prevent microbial contamination or particle ingress.

Extractables/Leachables Control

The materials must not release any substances into the product so as not to jeopardise product purity and patient safety.

Integration into validated processes

Sterile transfer bags and other single-use systems must be able to integrate seamlessly and safely into existing, validated filling and process lines.

OUR SOLUTIONS

Rhein-Plast solutions for aseptic applications

Rhein-Plast develops and manufactures specialised containment solutions for aseptic processes. Our continuous liners, sterile transfer bags with special ports and customised isolator bag systems are produced in our cleanrooms of ISO Classes 5, 7 and 8. We use exclusively high-quality, GMP-compliant polyethylene films, whose suitability is demonstrated by comprehensive extractables and leachables data. These systems enable the safe, contamination-free transfer of powders, components and liquids and ensure the maintenance of the sterile chain.

Primary packaging

Transfer bag

Continuous Liner

Custom solutions

Primary packaging

Transfer bag

Continuous Liner

Custom solutions

advantages

Advantages for aseptic processes

Sterilisable (Gamma/EtO)

Our products are suitable for common sterilisation methods such as gamma irradiation or ethylene oxide (EtO).

Low-particle

Manufacturing in the clean room guarantees minimal particle contamination.

Validatable (IQ/OQ/PQ)

Comprehensive documentation. All materials and processes fully documented in accordance with GMP standards.

Seamless process integration

Our systems are designed to integrate easily and securely into your existing installations.

PRODUCTS

Recommended products for asepsis

Primary packaging

PE bags and films for direct, sterile product contact.

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Transfer bag

Sterile transfer solutions for aseptic process steps.

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Special Containment Solutions

Tailor-made isolator bag systems for unique requirements.

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Request an aseptic containment solution

Speak to our experts about the requirements of your aseptic processes and find the right solution.