Controlled temperature chamber validations are one of the most commonly cited non-conformances in FDA 483s and warning letters. This is often due to the high cost of test equipment (to purchase or rent) or the labor and skills that many facilities don’t maintain in-house. In many cases, outsourcing can be expensive as well due to the specialization required.
We can help. We offer proven temperature mapping validation services that meet even the most rigorous auditor’s expectations at a fixed price far lower than almost any other option. We have protocols, procedures and test equipment for every type of controlled temperature environment – from ultralow freezers to autoclaves to warehouses. We can also provide fully customized services using your procedures.
All services conform to standard industry practices including open door and power loss testing. We can also provide services that conform to USP <1079>, Good Storage and Shipping Practices.