We offer development, assembly, laser-based micro-welding, packaging in clean rooms and preparation for sterilization. We have an ISO 7 Class 10,000 standard clean room and also laminar hoods for ISO Class 6 aseptic procedures, which require the highest standards of cleanness. Laserlux specializes in precise micro-welding, using state-of-the-art laser equipment, starting from minimal circumference of 50 micron laser rays, fine assemblies and electro mechanic assemblies for systems and products.
We perform procedure testing, operation and control activities on room temperature, humidity and pressure levels complying with ISO 14644. Support for regulatory and validation procedures and take part in CE and FDA and ISO testing. Work is performed in a clean room by a team of professionally trained employees:
- Daily air pressure, temperature and humidity control
- Continuous control and fault indication
- Environmental monitoring
- Water purifining system and tests
Laserlux clean environment area services include:
- A certified and well-trained staff
- The clean rooms ISO 7 (Class 10,000) are equiped with the ISO 6 (Class 1,000) the laminar hoods that allow easy pass of materials
- Use of clean room spaces for prototype development
- Cleanroom rental services
- Laser Micro-welding in a cleanroom
Laserlux specializes in assembling medical devices in a clean rooms in compliance with medical standard:
- Clinical batches manufacturing
- Small batches for V&V
- Batches for sterilisation
- Large batches for sale
- Different assembly solutions:
- Mechanical assembly
- Electro mechanical assembly
- Optical assembly
- Electro optical assembly
- Cleaning and washing:
- Mechanical cleaning
- Ultrasonic cleaning
- Dipping
- IPA/Ethanol cleaning
- Cleaning of electrical components
- Stream baths washing
- Drying under laminar hoods and compressed filtered air
- Packaging services with:
- NELIPAK machine for blisters
- Sealers for pouches
- Packing in large-size blisters
- Pre-sterilization processes:
- Packaging in sterile barrier primary and secondary packages
- Labeling
