Clean rooms
Chempilots has dedicated clean rooms to facilitate R&D and production of medical devices and controlled drug release systems. Our clean rooms are offered as an integrated part of our contract R&D services and for use during custom production.
Clean room details
Our clean room facilities include:
- Class 10,000 (class C) at rest: 3 clean rooms with dual locks (material and personnel, respectively), approximately 250 m² (2,700 ft²).
- Class 100,000 (class D) at rest: 2 clean rooms with single lock, 150 m² (1,600 ft²) and one clean room with dual locks, approximately 60 m² (650 ft²).
- Ventilation: Each clean room’s ventilation system is adjusted regularly to fit requirements. HEPA-filtered air enters rooms through ceiling-mounted bag diffusers and is not recycled.
- Water supply: R/O unit and a distillation plant with a ring held at 80oC (175oF) to provide purified water (PhEur).
- Sterilization: Matachana steam autoclave under current control.
Current clean room usage
We have a turnaround of 1-2 clean room installations per year to accommodate new projects or for scaling up an ongoing project. Dedicated clean rooms that are currently in operation include:
- A GMP cell for NO-loading of polymers. The air flow is balanced to give negative pressure inside the room to protect operators. Extensive safety installations are installed in the room and in the exhaust system.
- A bench work cell for injectable polyacrylamide hydrogels. Handling of acrylamide monomers requires absorbent filters in air exhaust system and restricted room access.
- Production lines for contact lens inks, for various antiseptic agents and for soft contact lenses. All lines have their own installations and special measures to prevent cross-contamination. Most of the lines are under external QA audit control.
Contact us
For more information please call Richard Schmidt on
+45 44 39 61 15 (9-17 CET) or send us an e-mail.
