Cleanrooms: From design to validation
Interflow creates functional solutions for complex air control issues. When designing and building our cleanrooms we focus on safety, comfort, sustainability, flexibility and ease of use. This guarantees a clean, usable, working environment which will protect you, your processes and your products.
- Customized Solutions: Based on your requirements and the information you provide, an ‘air’ technical installation is designed that meets your needs and follows the guidelines and regulations of appropriate authorities. By understanding your production process and the specifications of the environment, we will advise you on design solutions that will meet the required classification. Interflow offers you a customized total concept.
- Comfort: In terms of the cooling requirement it is important to know if there is any equipment in the cleanroom that dissipates heat to the space. Is the equipment suitable for use in a cleanroom? If not, what adjustments are needed? Are the requirements regarding temperature and relative humidity in the cleanroom realistic? Is there sufficient space for the required air treatment installations, plant and equipment? Our cleanroom specialists will help you answer these questions.
- Cost efficient: We always aim for a reliable, economic and cost-effective cleanroom. We use energy efficient installations such as heat recovery systems, energy efficient lighting and energy efficient fans. When designing your cleanroom, only high-quality materials and components are used that increase life span and reduce energy consumption. Low air resistance, controlled ventilation, heat recovery and selecting components with low energy consumption and high efficiencies ensure a sustainable design.
- One project team: During the design and construction of your cleanroom you will be communicating with one well-coordinated team that is experienced in working together when building a cleanroom. Our team will take care of all the project management requirements which will ensure all your ideas are developed into a cleanroom in which all elements are coordinated. The testing and commissioning service we undertake guarantees that your cleanroom is delivered fully operational and fully validated. We will advise you in the correct use and maintenance of your cleanroom by giving relevant instruction and training as well as giving advice on other items such as appropriate clothing etc.
Classifications: ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices).
Several standards are leading in the classification of cleanrooms, including:
- “NEN-EN-ISO 14644-1: 2016- Cleanrooms and Associated Controlled Environment”.
- “Guide to Good Manufacturing Practice for Medicinal Products”.
Interflow can advise you in the choice on which particle-free classification you need: A classification that is too high for your needs will incur unnecessary costs. It is also important to understand in which condition the cleanroom is to be assessed: as built, at rest or operational.
From January 2016 “NEN-EN-ISO 14644-1: 2015 ‘Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration” is the global ISO standard which has 9 classifications: ISO Class 1 to 9.
“Guide to Good Manufacturing Practice for Medicinal Products” is used by the pharmaceutical industry in the Netherlands. This document concerns the rules in the production of medicines in the European Union and include class A to D.