For two decades Nova Laboratories has provided clinical trial supplies to a global customer base. In this time the company has developed expertise in the use of high-integrity, gassed isolator technology which has been acknowledged by various regulators as ‘best practice’. The company’s work on complex and novel aseptic processes and clinical manufacturing of parenterals and devices has enabled it to develop commercial manufacturing processes for specialist sterile products that are to be marketed following successful clinical trials.
The company can design, construct and develop bespoke isolators, cleanrooms and associated process equipment for customers and boasts more than two million media fill simulations to date across a range of complex presentations with zero failure rate. This high level of sterility assurance is obtained by a combination of isolator design, use of highly trained staff, strict controls for the sterilisation of components, process design and the careful selection of suitable equipment for complex sterile processing.
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