High product quality from the clean room

For you as a manufacturer of medical technology products, efficient and adaptable manufacturing processes as well as securing and increasing your product quality are among the most important success factors. In order to prevent contamination of the products and processes – and not least hazards – for end users, manufacturing processes in medical technology are often only possible under clean room conditions. Strict legal provisions apply, which are anchored in DIN EN ISO 14644, DIN EN ISO 13485, the EU GMP guideline, the VDA and many other standards.

Flexibility is in demand

Whereas years ago oversized, centralized clean rooms were often built, the trend today is towards decentralized, flexible and modular clean room systems that can be variably extended. The decisive factor here is that the increasingly complex systems and components are precisely matched to one another. This means that the systems can always be adapted to changing conditions, not only during construction but also later on.

Avoid malfunctions in production

Development in the production of microelectronic components is proceeding at a rapid pace. Particle-free manufacturing environments are indispensable today. Even the smallest particles can lead to malfunctions and have a negative impact on product quality. Micromechanics is also subject to a trend towards miniaturization and high-precision production. To avoid malfunctions, manufacturing under controlled conditions is a success factor in this industry that should not be underestimated.

Clean room or controlled area?

Clean rooms mean investment costs, starting with the planning and continuing in operation. Please keep in mind that in many settings, a controlled area may already be sufficient, and can be accomplished on a smaller budget. A controlled area begins when critical particles are larger than the 5 µm as defined by ISO 14644. VDA 19 or ISO 16232 serves as the basis for controlled area. We would be happy to advise you whether a controlled area is the right solution for your requirements.

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Clean room technology for optical production areas

Particulate-sensitive components are very often used when working on optical benches. Even particles of the smallest size and concentration have a significant impact on the quality and functionality of your products. Improve your product quality and reduce your reject rates – manufacture under clean room conditions. In this way, your products meet the high quality requirements of the laser and optical industry.

Your research and development activities and the transfer to series production benefit from comprehensive contamination protection. At ENGIE Deutschland, we provide environments that protect your process from particulate or microbiological contamination. We design and construct the appropriate clean rooms and support you in the qualification and validation of the production unit.

Our customers include research laboratories where, in addition to straightforward product protection, the protection of persons is particularly important. The clean room technology is part of a controlled handling of hazardous substances based on the Hazardous Substances Ordinance (GefSubstanceV) of the BAuA.

In addition to research institutes, universities and colleges, development departments of companies with a wide range of applications are among our most important customers.

Hygienic production areas

By using clean room technology, you increase hygiene in the production, processing and packaging of food without thermal treatment and preservatives – this allows you to extend the best before date and reduce production costs.

Today's consumers are better informed than ever about the impact of nutrition on their health. Therefore, the production, processing and packaging of foodstuffs are of particular importance. As a manufacturing company, we at ENGIE Deutschland support you in creating a production environment that guarantees healthy and first-class food.

Clean room conditions for hygiene-sensitive plastics

As a processor of hygiene-sensitive plastics, you must reliably eliminate contamination risks that can ultimately lead to reduced product quality and potentially endanger end users. This is why injection molded parts are now increasingly produced under clean room conditions, especially in medical technology, pharmaceuticals, the automotive and food industries, chip production and electronics. A particle-free production environment plays a central role in the manufacturing process.

Injection molding and clean rooms

We differentiate between two approaches: Either the injection molding machines are connected from the outside to the clean room and equipped with LF modules or they are placed inside the clean room. The solutions differ significantly in terms of investment costs, operating costs and flexibility in the event of changes in the production process.

As is so often the case, there is no one right solution. Therefore, as a matter of principle, we strive to ensure that you, as the clean room user, cooperate very closely and in a spirit of trust with us, the clean room builder, at an early stage in the planning process. In a risk analysis, we jointly assess the different influences on the quality of the products to be manufactured, in order then to develop and implement an efficient and individual solution. We bring to the table many years of experience in the design and construction of clean room environments for the production of injection molded parts.