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

+49 6322 7980

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Quality

Aseptic filling

Primary packaging material for aseptic filling

Maximum process reliability, cleanroom suitability and regulatory compliance for your aseptic filling processes.

Asepsis

cleanroom

Pharmaceuticals

Biotech

Overview

Why aseptic filling places special demands

Aseptic filling places the highest demands on the cleanliness and integrity of all process components. Our GMP-compliant primary packaging materials made from polyethylene are specially developed for direct contact with sensitive pharmaceutical active ingredients. Through our manufacturing in cleanrooms up to ISO Class 5, we guarantee low-particle and microbiologically controlled packaging solutions that can be seamlessly integrated into your validated filling lines and maximise product safety. In aseptic filling, the aim is to fill a sterile product into a sterile container under sterile conditions in order to rule out microbial contamination. Every component that comes into contact with the product must itself be sterile and free from particles. Our primary packaging materials are therefore not just a shell, but an active part of the containment concept.

Critical requirements in aseptic filling

Particle control and sterility

Every particle poses a contamination risk. Our primary packaging materials are manufactured in cleanrooms of ISO classes 5, 7 and 8. They are suitable for common sterilisation methods such as gamma irradiation.

Material compatibility

The packaging must not enter into any unwanted interactions with the active ingredient. We use only qualified pharmaceutical-grade materials and provide extensive data on extractables and leachables.

Seamless integration

Our pouches and films must fit perfectly into highly automated and validated filling lines. We guarantee precise dimensional accuracy and consistent material properties.

OUR SOLUTIONS

Rhein-Plast primary packaging materials for aseptic processes

Rhein-Plast develops and manufactures high-quality polyethylene components that are specifically tailored to the strict requirements of pharmaceutical and biotechnological manufacturing processes. Our films and bags offer excellent chemical resistance, high mechanical stability and defined density properties. Production takes place in our certified cleanrooms (ISO 5, 7, 8) in compliance with GMP guidelines. We provide complete documentation to support your validation and approval processes.

Primary packaging

Cleanroom ISO 5/7/8

PE components

GMP-compliant

Validatable

Primary packaging

Cleanroom ISO 5/7/8

PE components

GMP-compliant

Validatable

Primary packaging

Cleanroom ISO 5/7/8

PE components

GMP-compliant

Validatable

Primary packaging

Cleanroom ISO 5/7/8

PE components

GMP-compliant

Validatable

advantages

Constant material properties

Precise dimensional accuracy

Guarantees seamless integration into your automated filling lines.

Constant material properties

Ensures the reproducibility of your processes and the stability of your products.

Systems that can be validated

Comprehensive documentation and certificates of conformity speed up your approval procedures.

Collaborative project support

Integration into isolators and cleanroom processes of ISO classes 5, 7 and 8 for maximum product purity and the highest process reliability.

Products

Suitable products for aseptic processes

Become our development partner for your aseptic filling

Are you facing a new challenge in aseptic filling, or are you looking for a reliable partner for your primary packaging materials? Speak with our experts. Together with you, we develop the ideal solution, precisely tailored to your processes and regulatory requirements.