ISO cleanroom classes at Rhein-Plast

Production in ISO 5, ISO 7 and ISO 8 for optimal alignment with your hygiene concept.

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explanation

Basics of ISO cleanroom classes (DIN EN ISO 14644-1)

ISO 14644-1 defines the classification of cleanrooms

Cleanroom classes range from ISO 1 (cleanest) to ISO 9 (normal room air). Classification is based on particle concentration per m³. Assignment: GMP Class A = ISO 5, B = ISO 5, C = ISO 7, D = ISO 8.

Our approach

Containment for each class

We manufacture flexibly in the cleanroom classes you need

ISO 5 (GMP A/B)

Aseptic filling, sterile production

ISO 7 (GMP C)

API handling, packaging

ISO 8 (GMP D)

Extrusion, packaging, storage

advantages

The right class for your needs

Rely on packaging from the correct cleanroom class

GMP compliance through certified cleanroom environments

Flexible selection of cleanroom class depending on product requirements

Cost-effective through selecting the right class for your needs

Complete documentation for your validation

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Discuss the cleanroom class for your product

We help you determine the optimal class for your requirements.

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