Catalog excerpts
§ADS 8 Biotec YOUR PATH TO DISCOVERY Contract ManufacturingIVD/OEM Material & Reagents_ ADS BIOTEC is your partner for manufacturing of "ready to use", fully traceable, supply-chain managed buffers, reagents and custom kits. We have been designing, developing and manufacturing custom reagents and kits since 2002. ADS BIOTEC serves a variety of client types, from startups to Fortune 500 companies. Whether you need custom-made solutions or routine production, we can help lower your capital investment, streamline your supply chain, and meet regulatory compliance requirements. Our end to end, ISO certified services are backed by a team of highly qualified technicians, allowing you to focus on developing your business while we take care of production and fulfillment. ADS BIOTEC can manufacture, warehouse and globally distribute your products. We have the manufacturing capabilities and infrastructure to manage your raw material sourcing through delivery of finished product to your customer. We manufacture aqueous and non-aqueous solutions in a wide range of fill sizes, from 5 ul vials through drum and IBC containers. We manufacture in HEPA-filtered clean production suites with complete flexibility to meet your commercial demands, whether it be sterile filtered or autoclaved and packaged in a clean room environment. Products can be tested using a variety of analytical and wet chemistry methods. We can perform testing per your Standard Operating Procedures. All QC personnel receive extensive proficiency training prior to each project. Highlights • Liquids manufacturing, both aqueous and non-aqueous • Hazardous and non-hazardous • Temperature controlled environments • Liquid batches up to 1,000L and also in multi-batch runs • Custom kitting and packaging • Product design and light assembly • Quality system: ISO-9001 certification\ISO-13485 complaint for CE IVD • Both domestic and global distribution
Open the catalog to page 1ADS Biotec YOUR PATH TO DISCOVERY Material and Reagent Manufacturing • Raw materials testing and inspection • Manufacture of reagents\buffers, including flammable liquid • In-process batch Quality testing and sample adjustments • Manufacture of kit components as well as assembly and packaging of complete kits • Finished product analysis • Consistent and reproducible high-volume production • Label design and packaging to meet customer specifications Evaluation capability • Documented protocols for raw materials acceptance and evaluation • Shelf-life/stability...
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