Controlled Environments

Facility Life Cycle

As we are a multidisciplinary business, customers can work with us in one field, for example air handling in a cleanroom, or for the whole facility, including permits and process plant. And in the latter case the customer benefits from having a single point of contact for the whole process. We prefer to take on the responsibility for the full facility lifecycle, and support our customers with regulatory compliance. Hence our services cover the full cycle:

Our Services for your

complete Facility Life Cycle

Step 1:

Consultancy & advice

During the feasibility stage it is investigated if there is adequate support for the project. Our specialists undertake objective feasibility studies and define the premises for the project as well as a schedule of requirements (brief). These provide essential input for the conceptual design. Our extensive knowledge and experience of legislation and regulations and the contents and structure of relevant standards enable us to advise our customers effectively. They may not get what they asked for, but instead what they actually need.

In our approach the project follows the process: the added value comes from understanding the customer’s process and interpreting that to provide a perfectly matched controlled environment. Additionally, Kuijpers Quality Services provides consultancy services in quality control (QC) and quality assurance (QA).

The basis of a good design is always a full understanding of the processes carried out in a space. This is both to ensure that guidelines and regulations are complied with and to consider the elements to be positioned in the space. The layout of the room and other aspects have a major impact on the financial aspects of the project. Kuijpers can advise you on the basis of our extensive expertise, so our customers can optimise their decisions.

We aim to distinguish ourselves on the basis of expertise, knowledge and experience during this important initial stage. We believe in getting it right the first time, so that the team can immediately continue with the next step and we reduce the cycle time of the project.

Step 2:

Design & build

If the feasibility has been proven and the project goes ahead we enter the design and build stage. As the relevant required standards and requirements depend on the type of controlled environment we liaise with the customer about all proposals and designs to ensure that their intentions and requirements are fulfilled. Are the functional design and detailed design correct, complete and compliant? Then it is time to start construction.

Our expertise of controlled environments and total lifecycle services enables us to:

· reduce the overall investment cost
· reduce the cycle time
· design in accordance with the budget.

In addition to the design and construction of controlled environments to ensure contamination control our experts also focus on commissioning and qualification. Kuijpers designs and builds in accordance with the ISPE Good Engineering Practices (GEP). This approach to design and construction ensures Quality by Design. It also results in a documented and qualified handover of controlled environments in which the customer’s processes can be operated in compliance with regulations and legislation. Because of the complexity of our projects, commissioning is not restricted to the handover – we undertake checks throughout the entire process.

Kuijpers advises, designs and builds on the basis of:
· IPSE 2001-2007
· GMP and GMP-z for Dutch hospital pharmacies
· NEN-EN-ISO-14644
· NEN-EN-ISO 14698
· EU Directive 2009/41: Contained use of GMOs
· EHEDG guidelines
· WIP Dutch guidelines for infection prevention
· VCCN (Dutch association for contamination control) guidelines for contamination control

Step 3:

Maintenance & operations

Once a we have handed over a correctly operating plant or facility, we support our customer with maintaining the controlled environment, through our maintenance and operations services. The focus is always on compliance.

Key requirement: compliance

You build a controlled environment for a reason, and there are specific regulations and guidelines for each market. Practically all our clients have to undergo regular inspections. Therefore it is essential that they demonstrably comply with quality and safety requirements.

Kuijpers specialists are not only aware of the regulations, requirements and standards but also understand them. This enables us to support our customers effectively and demonstrate the compliance status throughout the lifecycle, supported by evidence. We provide all the documentation required to prove this during inspections. Of course, we also ensure that this documentation is always kept current.

Curious how we can help you?

Please feel free to contact Harm.

Harm van den Oever Manager of Design & Engineering