Our Quality Policy

Our company motto includes the following two quality-related instructions.

Based on the fundamental policy set forth in the company motto, we have employed the following quality slogan.

This has been set forth to encourage us to always pursue the cutting-edge progress, not only in terms of products or manufacturing technology, but also in terms of quality. It also urges us to conduct more accurate and prompt inspections in order to be a company trusted by customers. Against this background, we established the following quality objectives in 2013. Since then, we have been continuing our endless pursuit of quality.

Quality Management Organization Chart

Quality Assurance Department

Shiotani Glass runs QMS (Quality Management System) smoothly and controls products in accordance with ISO standards to assure product quality consistently from material procurement and manufacturing up to shipment. Quality standards have been set for all processes to determine if product quality and safety are maintained in all processes and if products to be shipped satisfy the quality requirements, which serves as a check on production activities.

ISO Certification

Since ISO certification acquired in 2006, we have been keeping a high level of quality control.

Process and Manufacturing Validation

Pursuant to the GMP (Good Manufacturing Practice) ministerial ordinance, we verify the scientific evidences and validity to see if the manufacturing processes and methods used for pharmaceutical glass containers are proper and if the expected results have been obtained. Based on the results of verification, the manufacturing processes and methods are documented and applied to production.
In addition, procedure documents describing the raw materials and manufacturing steps have been prepared and used for each process.
Our Quality Assurance Department observes the Quality First policy and makes every effort to improve product safety and reliability.

Quality Control Section

Reliable Quality Control System based on Years of Experience

Shiotani Glass manufactures glass containers that come into direct contact with pharmaceutical preparations. Therefore, we have built up quality control system that complies with ISO 15378 (GMP for Primary Packaging Materials for Medical Products).
Our Quality Control Section takes charge of quality checks before and during production, as well as data preparation and shipping judgment. These quality checks cover a wide variety of items, not only product dimensions, shapes, and appearance, but also breaking strength (breaking moment) measurement, alkaline elution measurement, strength tests and more. Such obtained information will be fed back to the manufacturing processes in a timely manner, thus contributing to more stable and reliable product supply.

Quality Checks in Terms of Product Dimensions and Apparent Shapes

Measurement of Alkaline Elution

Strength Measurement

Confirmation of Strain Removal

Pharmaceutical glass containers are made from material tubes that undergo thermal processing to form them into the shape of containers. Since strain remains in the containers after the processing, they need to be heated again to remove the strain (this is called annealing). Shiotani Glass uses a polarizer to visualize the strain and make comparison between before and after annealing to see if strain has been removed without fail.

Issuing Inspection Report