Norgen Biotek has tremendous expertise in OEM and contract manufacturing of kits and reagents for the molecular biology and diagnostics markets. We currently manufacture OEM products for numerous companies on a continual basis. These companies are various sizes from small to large global companies. Norgen is an ISO 9001:2015 and ISO 13485:2016 registered company with an excellent Quality Management System and we follow strict SOPs for production and QC. Norgen operates in a 24,000 square foot facility with full development labs and dedicated manufacturing quarters that are maintained according to ISO and GMP requirements. We have an ISO Class 7 certified clean room housing an ISO Class 5 certified Filamatic liquid filling machine. The clean room is routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination to maintain the ISO classification of the clean room environment. Within our clean room we have high throughput liquid handling capabilities that would meet any job size, and we have validated liquid filling protocols for all types of bottle sizes. With our Filamatic liquid filling machine we are able to perform high throughput liquid filling and capping of bottles ranging in size from 0.1 mL to 500 mL with a ± 0.5% accuracy. Our Filamatic machine can be used to fill low, moderate and high viscosity fluids, making this a very versatile service for the biotechnology and pharmaceutical industry.
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