QUALITY ASSURANCE SYSTEM
Reliability and safety are most demanded for the primary packaging glass containers for pharmaceutical use. The scheme to protect the pharmaceutical preparation from physical and chemical effects, developed based on the knowledge and findings obtained for about a century. That is our “Quality Assurance System”.
Our Quality Policy
Our company motto includes the following two quality-related instructions.
All Actions and Words Begin with Trust.
Trust is the Life of the Company.
Based on the fundamental policy set forth in the company motto, we have employed the following quality slogan.
Evolve Powerfully to Be a Good Company!
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.
Make Continuous Improvement for Better Customer Satisfaction
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.
Since ISO certification acquired in 2006, we have been keeping a high level of quality control.
We have acquired ISO 9001 certification in all our business places: Osaka head office, Toyama factory and Malaysia factory.
Our Toyama and Malaysia factories have been certified to ISO 15378.
ISO 15378 specifies special requirements for applying ISO 9001:2015 that complies with the Good Manufacturing Practice (GMP) for primary packaging materials for medical products. ISO 15378 specifies requirements for GMP and QMS.
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
Measured in 1μm increments by contour tracer
Mainly used to measure the internal shape of the container’s mouth.
Dimensional measurement by projector
Portions that cannot be measured by vernier caliper are enlarged for measurement
Measurement by image measuring system
Enables accurate measurement without variation even for products with complicated shapes.
Also used for sampling inspection.
Measurement of Alkaline Elution
Measurement by atomic absorption spectrophotometer
Measurement by desktop pH meter
Mainly used for physical and chemical testing, such as analysis of eluted solution, preparation of reagents.
Moment measuring system (Breaking moment of cut ampoule)
Strength measurement by autograph tester
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
All products are shipped accompanied by an inspection report.