About Our Plant
Striving for a Plant of Worth Showing,
with Awareness of the Essence of GMP.
Inspection & Assembly Line
Inspection and Assembly
We undertake a 100% visual inspection of various components, such as plastic caps, gaskets and rubber stoppers under highly clean environment (actual measurements corresponding to class 10,000 approx.).
Process design is made for individual items on the basis of one specification-to-one item and submitted to customers for approval. Based on data obtained through an initial investigation of the quality level of each packaging component, we initiate designing the process and preparing SOPs to suite customer’s quality criteria. Lot control can be implemented for the product as well as each component to ensure their traceability.
For designing a suitable package, after confirming how our customer receives and uses each component at their site, we offer an optimal packaging specification, for instance, shrink packaging, outsourcer’s original packaging, double wrapping, individual packaging. Inspectors engaged in visual inspection are all qualified based on internal criteria.
They are educated and trained based on SOPs, and undergo regular checkup for inspection accuracy using defect samples.
We undertake all burdensome jobs from procurement, supplier management, inspection & assembly, and to quality assurance, hence customers can expect labor-saving and curtailment of production cost.
Further, our Shiga Plant is registered as manufacturing site for medical devices, and is capable of performing inspection and/or assembly.
In addition to that, since a license for manufacturing and marketing of class II medical devices has been acquired, it now becomes possible to file an application for and distribute class I and II medical devices,too.