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




