Clean Room Design
Holistic clean room planning by Glatt Engineering that brings together all interfaces and engineering disciplines in advance
Holistic clean room planning by Glatt Engineering that brings together all interfaces and engineering disciplines in advance
Clean rooms are indispensable in the pharmaceutical industry. Only with them can the requirements for contamination-free production defined in the relevant GMP regulations and other guidelines be met. This applies equally to liquid and solid pharmaceuticals and in sterile and non-sterile environments.
The early consideration of this discipline in the project significantly influences its success. The selection of a suitable cleanroom system, its design, integration into the building structures, the selection of suitable cleanroom furniture, wall systems, flooring systems, coving, media integration, glass elements, clean room doors, panel ceilings, clean room luminaires, integrated washing stations – just a small selection of questions that need to be considered early on in the project, the effects of which are often underestimated, but which cost a lot of time during planning and are financially relevant, thus influencing the overall success of the project.
As a developer of innovative OSDs as well as a contract manufacturer for pharmaceutical and other GPM-regulated solid products, we have many years of experience within the Glatt Group. Our knowledge of the requirements for production under clean room conditions motivates and enables our clean room planners to achieve creative and successful results.
One example of this is the development of a special solution for a maintenance-free, seamless clean room washing station.
clean room design in practice
A, B, C and D are more than just letters for us! Which clean room classes challenge your project? Whether it’s a GMP pharmaceutical, high potent active substance, biotech or food project – we develop a suitable clean room solution for every area of application. This must meet the requirements resulting from EN-ISO 14644 and the EU GMP Annex 1 guidelines, among others.
Supported by our building services team, we use energy-efficient technology for you. You save costs and optimize the CO2 footprint of your clean room. Your production becomes competitive and flexible for possible future expansions.
Cleanrooms as an integral part of complex system planning – take us at our word and let us develop your optimum solution.
Weimar, Germany, January 2022: Plant manufacturer and process expert, Glatt Ingenieurtechnik, from Weimar, Germany, has developed a seamless cleanroom washing area that has already successfully passed practical tests at both the company’s own technology center and customer sites.
It’s hard to imagine a pharmaceutical industry without cleanrooms, which have to meet increasingly stringent requirements. From the very beginning of a project, companies should involve an experienced planner to build or redesign a cleanroom. Coordinated communication between the various suppliers then ensures both efficient implementation and regulatory compliance.
When it comes to current GMP regulations and other specifications, cleanroom requirements are clearly defined. Customer specifications, the choice of systems and the details of the design are all crucial considerations. Ronny Töpfer, Project Engineer at Glatt Ingenieurtechnik (Weimar, Germany) explains what’s important in terms of walls and other associated components.
In advance of any cleanroom project — whether it’s a conversion or a new build — careful and comprehensive planning is essential. Before the start of any pharmaceutical cleanroom assembly, such as the interior fit-out, all structural work must be completed as fully as possible. This means that the building shell should be finished and the construction site must be completely clean. This is the only way to ensure that no particles are transferred from the surfaces of the building fabric into the cleanroom to be constructed.
Further information on this topic and related topics can also be found in the following publications:
December 2023: Glatt wins follow-up order for BioCampus MultiPilot in the port of Straubing-Sand
August 2022: ‘Glatt selected for Engineering Project for new GMP Biorefinery by NSTDA in Thailand’
Published article: ‘How to move biopharmaceuticals productions smoothly and quickly into Asian markets’ PDF, Englisch
Published article: ‘High Containment Processes in the Solid Drugs Production’ PDF, Englisch