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

+49 6322 7980

info@rhein-plast.de

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

+49 6322 7980

info@rhein-plast.de

Contact

HPAPI / OEB-5 processes

Safe handling of highly potent active ingredients (HPAPI)

Maximum personnel safety and product integrity with our certified OEB 5 containment solutions.

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Configure solution now

HPAPI

OEB 5/6

Pharmaceuticals

Containment

Overview

What are HPAPIs and why are they particularly demanding?

Handling highly potent active substances requires uncompromising safety. Highly active pharmaceutical ingredients with extremely low OEL values (OEB 5 and above) require special containment measures. Our HPAPI containment portfolio, in particular our DÜPOLEX® endless liners, offers certified protection for OEB levels 4 and 5. These systems prevent cross-contamination and reliably protect employees from exposure to toxic substances. Through GMP-compliant cleanroom manufacturing and validated processes, we ensure that your OEB 5 containment strategy meets the highest regulatory requirements while also enabling efficient production workflows. Rhein-Plast offers modular solutions for this need.

The challenges in HPAPI processes

Extremely low exposure limits (µg/m³ range)

OEL values in the microgram range require containment systems that reliably contain even the smallest particle quantities.

Complex regulatory requirements

HPAPI processes are subject to the strictest requirements, from GMP and OEB classifications to environmental protection regulations.

Risk to personnel and the environment during open handling

Without closed systems, even the smallest amounts of active ingredient can cause serious health damage to employees.

OUR SOLUTIONS

The Rhein-Plast portfolio for HPAPI processes

Continuous Liner / endless containment, transfer and connection bags, primary pharmaceutical packaging with GMP material, customised film solutions. All products are manufactured from high-quality, GMP-compliant polyethylene films in our German cleanrooms and enable enclosed, dust-free transfer.

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Continuous Liner

Transfer bag

Primary packaging

GMP material

Continuous Liner

Transfer bag

Primary packaging

GMP material

Continuous Liner

Transfer bag

Primary packaging

GMP material

Continuous Liner

Transfer bag

Primary packaging

GMP material

Request a consultation

Request a consultation

advantages

OEB 5/6 Compliance

Dust-free

Closed processes without particle release to protect personnel and product.

OEB 5/6 Compliance

Demonstrable compliance with the highest containment levels, verifiable and documented.

GMP-compliant materials

Pharmaceutically qualified PE films from our own in-house extrusion.

No extensive conversion

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

DÜPOLEX®

The premium film for your HPAPI containment

Our proprietary film technology offers superior mechanical strength and anti-static properties.

For the safe handling of highly potent active substances, film quality is crucial. Our DÜPOLEX® films set the standard here.

Permanent anti-static

Prevents powders from sticking and reduces the risk of explosion.

High tear and puncture resistance

Minimises the risk of leaks and ensures maximum process safety.

Certified purity

Manufactured under ISO and GMP conditions to eliminate product contamination.

Validated barrier and sealing properties

Integration into existing systems without costly modifications.

Areas of application

Typical areas of application for OEB 5 containment

From API manufacturing to filling: secure processes across the entire value chain.

Sampling

Contamination-free sampling from reactors or mixers.

Dispensing & Weighing

Dust-free decanting and refilling of powders and granules.

Tablet pressing & encapsulation

Safe loading and unloading at production facilities.

Filling & Packaging

Closed transfer of APIs in primary or secondary packaging. Our continuous liners for OEB 5 are a flexible and efficient solution.

Products

Recommended products for HPAPI processes

Continuous liner / endless liner

Our endless liners guarantee the highest level of product and personnel protection in critical production environments such as the pharmaceutical and battery industries. Safe, verifiable and immediately integrable.

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FIBC liner

Our Big Bag liners protect sensitive bulk materials in the pharmaceutical, chemical and battery industries. GMP-compliant, antistatic and tailored individually to your process.

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Transfer bags, batch bags & beta bags

GMP-compliant single-use systems for contamination-free handling of powders and components in pharmaceutical production.

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Continuous liner / endless liner

Our endless liners guarantee the highest level of product and personnel protection in critical production environments such as the pharmaceutical and battery industries. Safe, verifiable and immediately integrable.

View product

FIBC liner

Our Big Bag liners protect sensitive bulk materials in the pharmaceutical, chemical and battery industries. GMP-compliant, antistatic and tailored individually to your process.

View product

Ready for safe HPAPI containment?

Contact our experts for personalised advice on your OEB 5 application.

Contact experts now

Contact experts now