Shiotani Glass manufactures glass containers that come into direct contact with pharmaceutical preparation. We have built a production control system that complies with ISO 15378 (GMP for Primary Packaging Materials for Medical Products) required for pharmaceutical containers to ensure reliable and safe production.

Production Control Highlights

Shiotani Glass has uniquely established strict control standards for reliable and safe production. The following highlights some of the standards.

Material Tube Packaging and Acceptance Check

Pharmaceutical glass containers are made from material grass tubes that undergo thermal processing to form them into the shape of containers. Therefore, handling of material tubes is important. All the delivered material tubes are assigned with a lot number to enable traceability.

The truck yard where material tubes are delivered is provided with three shutters that are interlocked to prevent from being opened at a time.
Pest control is in place with advice from Earth Environmental Service, a pest control professional.

Material tubes are delivered, wrapped with shrink film to prevent entry of foreign substances.

A fixed quantity of material tubes is picked up lot by lot and subject to dimensional inspection (appearance, diameter, wall thickness, etc.), and stored in our warehouse.

Semiautomatic warehouse with moving rack can store 30 rows, up to about 1,300 pieces of pallets. Inventory control in cooperation with the production control system is enabled. Dustproof rubber tires are employed and sensor-based safety system is provided to ensure clean and smooth product control.

Clear Water from the Sho River, Toyama Used to Clean Material Tubes

Material tubes are cleaned one by one, using the unique cleaning system developed on our own. Clear underground water from the Sho River, Toyama is filtered through RO (reverse osmosis) membrane is used as cleaning water. The raw water in the Sho River, Toyama is about three times as clean as that in Osaka. This clean raw water is further purified for use in the cleaning process.

Packaging Material Preparation Room

To prevent contamination, packaging materials to be used for products are cleaned and assembled in advance in the preparation room (Class 30,000 cleanroom). We can meet various requests such as material changes to plastic or plastic cardboard, bulk package (no outer package used).