We maintain a Class 8 / 100K cleanroom that conforms to ISO14644-1 Class 8 and a white room for clean electro mechanical products. Optimal production environment is is achieved by routine maintenance and surveillance on bio-burden level and particle count level with calibrated equipment and certified laboratories. Only water purified by reverse osmosis process is used in our processes.
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 has completed with installation qualifications (IQ) and each molding project will perform operation qualification (OQ) and production qualification (PQ). Our machines range from 30 to 120 tones.
Assembly and Secondary Operations
Every project is different and our production engineers will develop well thought working instructions for each unique steps. 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.
Our medical packaging solutions adhere to ISO 11607 and other necessary shipping, environmental and accelerated aging test requirements. Common packaging solutions include nylon, PE or aluminium with tyvek backed pouch, blister tray sealing with medical paper or tyvek lid.
We work closely with our sterilization 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 irradiation (Gamma/E-beam) (ISO 11137).