质量文件

ISO 9001Download PDF

Product quality assurance

In the manufacture of bacterial culture media, we believe that "quality is not a coincidence, but the result of systematic management," and have established a manufacturing system that conforms to the principles of ISO 9001:2015, the core standard for international quality management systems. In particular, for the product groups intended for use in the pharmaceutical and bio-related fields, we are committed to achieving scientific and systematic quality assurance through not only simple adherence to product specifications, but also risk-based thinking for each process, thorough implementation of the PDCA cycle, and ensuring traceability. Furthermore, our quality assurance department conducts a complete review of the manufacturing records for each production lot, and thoroughly implements the eight quality management principles required by ISO 9001 (customer focus, leadership, process approach, etc.) in all processes, from checking the CoA when raw materials are received to determining whether the final product should be shipped. In this way, the bacterial culture media we provide are not just products, but "crystals of trust born from a management system backed by international standards," and we guarantee their quality so that they can be used with confidence by pharmaceutical companies, testing organizations, and research facilities around the world. Compliance is not an option — it is our baseline. Excellence is where we begin.

OUR CAPABILITIES

As a company specializing in the research, development, and manufacturing of culture media for microbial detection, our company philosophy is based on thorough product quality management based on the three pillars of "safety," "reproducibility," and "high reliability."All of our products are shipped from our own ISO 9001-certified factory after undergoing a multi-stage quality confirmation process that complies with international standards, from raw material lot management to aseptic filling and sampling inspection of the final product. In addition, we conduct performance tests (growth promotion tests, etc.) for each product in accordance with the standards of major pharmacopeias, including USP, EP, and JP, and, where necessary, we also confirm compliance with biopharmaceutical guidelines such as ISO 9001. Furthermore, to deliver consistent performance in the field of microbiology, where minute variables abound, we routinely conduct lot-to-lot reproducibility tests and environmental stress tests (temperature, light, pH, etc.). Through this series of processes, we guarantee the quality our customers can use with confidence. We believe in "product quality," and we promise to continue to be more than just a reagent provider; we are a true quality assurance partner that lives up to our customers' trust.




                      

质量证书

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

产品

HAYFLICK Agar is added with horse serum to provide beneficial cholesterol and fatty acids. Deoxyribonucleic acid provides purine and pyrimidine bases, which mycoplasmas are unable to producing。 Phenol red changed the medium’s color to yellow or purple,