We maintain a 100K cleanroom that conforms to ISO14644-1 Class 8. We ensure that our production environment is kept to the highest standard by maintaining routine cleaning on a regular basis and ongoing monitoring on our bio-burden level and particle count level with our own laboratories. Water used in medical device related operations is purified by Reverse Osmosis process.
Our injection moulding division is well equipped to produce both engineering plastic and liquid silicon rubber. We are also capable to make twin shots overmoulding or insert moulding. We are familiar with performing operation qualification (OQ) and production qualification (PQ) on injection moulding for mass production; or we can also accept injection moulding validation by First Article Inspection (FAI) with a more stringent online real time quality assurance. Our machines range from 30 tones to 120 tones.
Assembly and Secondary Operations
Every project is different and our project team together with the production engineer will develop well thought unique working instructions for each project from scratch so that best practice will be adopted. Our assembly could also cover other secondary operations including multi-colour pad printing, high-speed non-contact ink jet printing, ultrasonic welding, spin-welding, UV or EFD gluing. We can also work with our customer to make custom build semi automatic or fully automatic assembly line.
We have facility, knowledge and experience to perform packaging validations and OQ and PQ on medical device packaging that complies with ISO 11607 and all necessary shipping, environmental and accelerated aging test. Common packaging solution include Nylon, PE or Aluminium pouch sealing with medical/tyvek paper and blister tray.
Our experience in sterilisation is wide. While we outsource our sterilisation service to our collaboration partners, we monitor the entire process and have the capability to develop our own protocols to govern the entire process in accordance to ISO standards, whether they are Ethylene Oxide (ISO 11135) or Radiation (Gamma/E-beam) (ISO 11137).