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Quality
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True Traceability System™
Factory structure
All processes are designed to prevent contamination, and clean room wear is mandatory there. In particular, washing, inspection, and packaging processes are designed and managed in the structure suitable for GMP standards.
Formulation design
When the rubber formulation is designed, cytotoxicity tests, acute toxicity tests, pyrogenic tests, and hemolytic tests are carried out. We are conducting Extractable Testing in conjunction with European inspection agency, and we can provide the relevant data upon customer request.
Final packaging process
The packaging process takes place in the area of ISO CLASS 5. It is managed in accordance with the ISO 14644-1 standard.
Physico-chemical test and physical property test
Samsung Medical Rubber has rubber stopper test equipment that can conduct physico-chemical tests suitable for each country. We can conduct tests such as KP, JP, EP, USP, ISO, etc.
IPC SYSTEM
The inspections in all processes comply with a system suitable for ISO 15378. The related matters are recorded in our Manufacturing Execution System, and the quality items can be checked for each LOT anytime, anywhere.
Microbial test
We operate our own microbiology laboratory, and testing for bioburden, endotoxin, airborne microbe, settle plate microbe, surface microbe, and E. coli is possible.
QUALITY SYSTEM
Samsung Medical Rubber's quality system complies with ISO 15378:2017 and ISO 9001:2015, and specifies the quality management system requirements for manufacturers of primary packaging materials for pharmaceuticals and medical devices. Our standard describes GMP principles and sets out QMS requirements that apply to the primary packaging of pharmaceuticals. We carry out strict quality control based on appropriate results within the "Micro Test, Plastics U.S.P. Class VI with Implantation, MTL Test #2017" experiment.
Environmental monitoring
Our products are manufactured and inspected in Class 100 and Class 100,000 clean rooms. We maintain and manage the clean rooms that meets the standards for each class for airborne microbe, settling plate microbe, surface microbe and airborne particle through environmental monitoring. In addition, we maintain and manage Water System's WFI to meet USP and EP standards.
