Tailor-made solutions for your Cleanroom

Hygiene and safety are your main concerns within the pharmaceutical industry and avoiding the risk of contamination is a top priority. It is critical to ensure contamination control during pharmaceutical research or manufacturing process. Our professional, technical clothing rental and laundering solutions, in full compliance with industry standards, relieve you of these daily concerns. This allows you to focus on your core business: developing and manufacturing quality medicines safely.

The pharmaceutical industry manufactures all types of medicines in different forms such as compacted powders, capsules and liquid solutions. Each component must be processed on different production lines, to comply with the strict requirements of the EU GMP (Eudralex Volume 4).

GMP and pharmaceutical industry

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

The GMP is defined by European regulatory agencies to guarantee the standard quality of medicinal products. The manufacturing process must ensure the safety, purity, and efficacy of the product. Compliance with GMP is necessary to:

  • Manage a safe and reliable production line.
  • Avoid cross-contamination between different chemical components and other contaminants.
  • Maintain a fast and efficient multi-product production.
  • Provide a high-quality product.

 

This GMP also contains the recently revised Annex 1 call “Manufacture of Sterile Products”. Annex 1 is one of the 20 annexes that make up the GMP guide. Intended for companies in the pharmaceutical sector, Annex 1 shows the principles and procedures to be followed for the manufacture of sterile medicines for human and veterinary use. To know more about the Annex 1 and the modification that implies for your process, click here

Our solutions for the pharmaceutic industry

Why choose Elis Cleanroom

  • Elis cleanroom - controlled enviroment laundry

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    A controlled environment

    The optimal production for pharmaceutical industries requires that critical production processes are carried out in a contamination controlled environment. This is because particles pose a high risk of contamination to pharmaceutical production processes. The cleanroom environment eliminates the hazard of particulate and biological contamination, and this reduces the risk of product failure to the minimum, ensuring the promised, predetermined protection to your production.

  • Elis Cleanroom garment

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    Suitable workwear

    As a manufacturer, you need to protect your employees and provide them with the right equipment. With its large range, Elis Cleanroom offers tailor made solutions, qualified for ISO class 6/7 and 4/5.

  • Elis Cleanroom garment maintenance

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    Choosing maintenance rental to contribute to the circular economy

    Based on the economy of functionality, the Elis model favours service over product, rental over purchase. The Elis Group also works in other areas of the circular economy: repair, reuse, reconditioning or recycling to extend the life of products for as long as possible, according of course to predefined qualification tests. Product sustainability is at the heart of Elis' DNA. Our ambition is to provide you with a responsible, high-quality offer, with less pressure on natural resources and the environment.

Maintenance rental service

With our rental service, we help you focus on your core business, while keeping your budget under control.

  • The purchase and storage of your items: As you do not have the time to deal with the management of the clothing for your teams, we take care of the purchase and storage of your items.
  • Maintenance of your items: We carry out quality controls at each stage of the treatment of your garments, in specialised factories.
  • Regular delivery and collection: We adapt our services to your rhythm and preferences (times, storage area, quantities, etc)
  • Your needs assessed by our experts: We study your needs beforehand, to offer you tailor-made solutions.

Customer references

  • A healthy environment
  • Client Dopharma logo
  • "I have regular contact with the account manager of Elis Cleanroom, so he knows exactly what is going on within our organization. That is why everything runs smoothly with us"

    Henny Roks Sterile Manufacturing Manager at DoPharma

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