Increased batch processing capabilities enable production of up to 1,600-kg lot sizes. Production adheres to a strict ISO 9001:2000 compliant documentation program to assure lot consistency,identification, and traceability. Batch records are required to follow the product through manufacturing, cleaning, testing, packaging, and labeling.
Laboratory Production. Laboratory production offers synthetic and rare amino acids, metabolic intermediates, chromogenic substrates, high-purity fluorescent label compounds and histochemical stains. Lab synthesis quantities range from milligrams to kilograms.
Research Organics offers custom synthesis and scale-up capabilities. Chemists coordinate with customers technical personnel to identify critical specifications and develop compounds suitable for these needs.
Research Organics is an ISO 9001:2000 certified and registered manufacturer of biochemicals compliant to strict industry and international standards for quality assurance. The companys quality system monitors batch processes to ensure conformance to controlled specifications,procedures and lot traceability. QS inspects all batch lots, utilizes statistical process controls, and adheres to cGMP guidelines in equipment qualification, product testing, methods validation, change control, impurity profiles, stability studies, and out-of-specification procedures.
Quality Control Testing. Quality control tests raw materials and
authorizes release into batch processes. Each in-process and final batch
lot is tested to conform to internal and customer specifications. Analyt