15 July 2024
Why the design phase within CLIMB is essential
With our experience and the unique Cleanroom Implementation Blueprint (CLIMB), we offer your organisation the guidance and support needed for a successful project journey. In this blog, we dive into the crucial design phase of CLIMB and explain why this phase is vital to the success of cleanroom projects.
What is CLIMB?
CLIMB stands for Cleanroom Implementation Blueprint. It is our unique approach to guiding and supporting cleanroom projects from concept to implementation and even beyond. With CLIMB, we provide a structured roadmap designed to guide organisations through the entire cleanroom process, from the initial steps of process mapping to ongoing monitoring of the operational cleanroom.
The impact of design
The design phase within CLIMB is essential to laying a solid foundation for any cleanroom project. Therefore, this phase involves more than just sketching a floor plan; it is a comprehensive analysis and step-by-step elaboration that ensures that the design takes optimal account of safety and quality requirements in accordance with PIC/s. Let's dive into some crucial elements of the design process.
Time saved through early involvement
By involving Normec Advipro in the cleanroom project from the beginning of the design phase (or earlier), collaboration can be achieved so that results from analysis during the process mapping and design process can be incorporated into the design. This results in significant time savings and avoids missed opportunities for optimisations and improvements in the design, which will later have to be overcome by, for example, additional procedures. Which again, is a delaying factor.
Cleanroom floor plan = check! Now what?
Quality control and error prevention
Another critical role is to perform quality checks. Normec Advipro carefully verifies that the developed floor plan meets cGMP standards and is in compliance with regulations, including PIC/S and Eudralex Volume 4. In other words, we verify that the design is optimally worked out in order to perform the activities in the safest and highest quality manner possible. Incorrect design decisions can later have a major negative impact on functionality and safety within the cleanroom.
Our expertise allows us to identify and correct potential design errors and shortcomings before they become costly problems. For example, it verifies that the separation of activities is correctly pencilled in, waste flow is correct, there is sufficient space for storage of product and material according to zoning, etc.
This not only ensures a higher level of quality, but also saves time and resources in the long run.
Normec Advipro's design review checklist
Normec Advipro has developed its own design review checklist within CLIMB, which is continuously updated to check every detail in the design against the cGMP and regulations, making any necessary comments, recommendations or questions. This ensures that all aspects of the design meet the highest standards. This systematic approach allows us to guarantee the quality and compliance of the design.
Collaboration and communication
In the design phase, collaboration and communication are also crucial. At Normec Advipro, we work closely with your team to ensure that all requirements and wishes are incorporated into the design according to URS. This collaborative process ensures that the end result meets not only the technical specifications, but also the operational needs of your organisation.
Conclusion
The design phase within CLIMB is a crucial step for the success of cleanroom projects. Through early involvement, in-depth quality checks, use of visual aids and close collaboration, we ensure an efficient and effective project process.
At Normec Advipro, we are proud to support organisations in their pursuit of perfection in cleanroom environments. With CLIMB, you are assured of a structured and reliable approach that will take your cleanroom project to new heights. Contact us via the button below to find out how we can support you with your cleanroom project.