We maintain a Class 8 / 100K cleanroom that conforms to ISO14644-1 Class 8. We also have a white room for clean electro mechanical products which does not require a cleanroom environment. We ensure that our production environment is maintained to the highest standard by maintaining routine cleaning and ongoing monitoring the 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 manufacture both engineering plastic and liquid silicon rubber. We are also capable of twin shots over-molding or insert moulding. All machines have gone thru installation qualifications (IQ) and each molding project will perform operation qualification (OQ) and production qualification (PQ) on injection molding process for mass production. Our machines range from 30 tones to 120 tones.
Assembly and Secondary Operations
Every project is different and our project team together with production engineers will develop well thought unique working instructions for each project from scratch so that best practice will be adopted. We also provide other secondary operations such as up to 5 colour pad printing (or tampo printing), high-speed non-contact ink jet printing, ultrasonic welding, spin-welding, heat stake and UV or EFD gluing. We can also work with our customer to make custom build semi automatic or fully automatic assembly line. We also flexible to assembly setup including the utilization of a conveyor belt line or a cell line.
We have facility, knowledge and experience to perform packaging validations on medical device packaging that complies with ISO 11607 and all necessary shipping, environmental and accelerated aging test. Common packaging solutions include Nylon, PE or Aluminium pouch, blister tray sealing with medical paper or tyvek paper.
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).