Full Design Package
It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Our qualification process is not an independent activity but an integrated application of GxP practices.
Based on the User Requirement Specification, Design Qualification is the documented verification that the proposed design of the facilities, systems and equipment, is suitable for the intended purpose. It starts right from the conceptual design phase of the project. We integrate current regulations and guarantee the performance of the rooms, in accordance with the parameters as stipulated in your URS.
Our 2D and 3D design package, along with our virtual tour, offers you a unique preview of your entire facility before it is built. This enables us and your end users to optimise the layout, simulate work and materials flow, and also check maintenance related activities upfront. This approach avoids delays and modification costs at later stages of the project.
Functional Systems with Advanced Control
Over the years, we have developed proven envelope solutions and reliable HVAC concepts for many applications. Our systems meet the required ISO classification as well as qualification to international cGMP.
Functional and mechanical system design is essential to achieve GMP regulatory compliance. Our cleanrooms deliver the highest quality with controlled running costs. Each one features an air handling system that is optimised for the intended application and operates with redundancy to improve reliability.
Our ECO2 control system helps simplify all aspects of cleanroom management. It allows control of the full range of cleanroom auxiliary items to achieve optimum conditions for lighting, temperature, humidity and particle counts. Users can remotely control and monitor multiple rooms, and it can be integrated with existing facilities management systems and business management systems.
Commissioning, Qualification, Validation
Qualification is a method of systematically demonstrating and documenting that facilities, systems and equipment perform as intended.
- Installation Qualification is a documented process that ensures the facility and equipment provide what is required.
- Operational Qualification verifies and documents that the as built facility and equipment operate in accordance with the design specifications.
- Performance Qualification or Process Validation verifies that the loaded facility and equipment perform as intended. Performance Qualification is also an ongoing process, meeting annual qualification and validation requirements for GMP facilities.
As an essential part of GMP, Qualification and Validation should be part of an ongoing programme, specified in your Quality Manual and Validation Master Plan.
Our commissioning process verifies that what was specified was installed, that it functions properly, and that the installation can be handed over to be qualified. Typical activities in this phase may include design reviews, factory acceptance testing, site acceptance testing, and functional testing. The results are documented, and any deviations encountered during testing are logged, corrected and retested.