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

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API manufacturing

Containment systems for API manufacturing

Maximum process reliability and personnel protection in the production of pharmaceutical active ingredients, from development to commercial production.

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API

OEB 4/5

GMP

Containment

Overview

The central role of containment in API manufacturing

The manufacture of active pharmaceutical ingredients (API) is at the heart of the pharmaceutical industry. To meet GMP requirements and protect both personnel from highly potent substances and the product from contamination, containment systems are essential for API manufacturing. Closed production processes minimise the risk of particle exposure and ensure product integrity throughout every process step. Rhein-Plast provides validatable, tried-and-tested solutions for this purpose, specifically designed for the stringent regulatory framework of API manufacturing (GMP) and enabling the safe handling of active ingredients up to OEB 5.

challenges

Typical challenges in API production

People and product protection

Open processes expose employees to the risk of exposure to highly active or toxic APIs and jeopardise product purity through contamination.

Regulatory compliance

Compliance with strict GMP guidelines and OEB limits (Occupational Exposure Band) is essential for approval and operation. OEB 4 containment is often the minimum requirement.

Cross-contamination

In multi-product facilities, carryover of active ingredients between different batches must be reliably prevented so as not to jeopardise patient safety.

OUR SOLUTIONS

Flexible containment systems for API manufacturing

Rhein-Plast develops flexible single-use containment systems for API manufacturing that can be seamlessly integrated into existing plant. Our solutions, such as Continuous Liners, transfer bags and FIBC liners, create closed production processes and ensure dust-tight handling of powders and liquids. Manufactured from high-quality, pharma-compliant films (optionally antistatic with DÜPOLEX®), our products meet the requirements of API manufacturing in accordance with GMP. They provide a secure barrier that prevents cross-contamination and ensures the highest product purity from raw material to finished active ingredient.

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Continuous Liner

FIBC liner

Transfer bag

DÜPOLEX®

Continuous Liner

FIBC liner

Transfer bag

DÜPOLEX®

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advantages

Benefits at a glance

Maximum security

Effective protection for your personnel and your products through closed systems up to OEB 5.

Prevention of cross-contamination

Single-use systems eliminate the risk of carryover between batches.

GMP compliance

Our solutions are manufactured under ISO 9001 in cleanrooms (ISO 5, 7, 8) and are fully validatable.

Flexibility

Simple integration into existing processes without expensive modifications, ideal for multiproduct facilities and CDMOs.

PRODUCTS

Suitable products for API manufacturing

Continuous liner / endless liner
For the safe filling and transfer of powders.
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Transfer bag
For the contamination-free transport of APIs and intermediates.
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FIBC liner
For the dust-tight handling of large quantities of bulk materials.
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Continuous liner / endless liner

For the safe filling and transfer of powders.

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Transfer bag

For the contamination-free transport of APIs and intermediates.

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FIBC liner

For the dust-tight handling of large quantities of bulk materials.

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Design your API manufacturing to be secure and GMP-compliant

Our experts will be happy to advise you on the right containment solution for your process.