Clean Rooms Designed to Qualify
We manage the design and construction of clean rooms, and the validation activities around them. You get one team from the first user-needs review to rooms that are commissioned, qualified and handed over.
Three Stages, One Team
Design
Reviewing the required equipment and utilities, understanding user needs, setting the budget and managing the tender.
Construction
Selecting the contractor and managing construction, with the architects, HVAC and electrical teams coordinated as one project.
Before Hand-Over
Commissioning and validation of the equipment, the HVAC system and the clean rooms. Validation testing is managed by us and performed by an external contractor.
EU GMP Clean Room Grades
Airborne particle classification per EU GMP Annex 1 and ISO 14644-1. We design the room and the pressure cascade around the grade each step of your process needs.
| Grade | At rest | In operation | Typical use |
|---|---|---|---|
| A | ISO 5 | ISO 5 | Aseptic filling, open product, LAF zones |
| B | ISO 5 | ISO 7 | Background for Grade A in aseptic work |
| C | ISO 7 | ISO 8 | Solution preparation, less critical steps |
| D | ISO 8 | Set by site | Component handling, airlocks, washing |
One Team, Five Disciplines
Planning a Facility, a Line or a Validation?
Tell us what you are building. An engineer will get back to you.