Our staff is experienced at validating methods for sterilization of medical devices, clean room validation, packaging validation, and disinfectant validation for the Medical Devices Industry.

We have the facilities to undertake stress testing as outlined in the relevant ASTM/ICH/ISO guidelines for the validation of sterilization methods. We are also happy to validate methods developed in-house; client supplied methods or published methods, such as compendial monographs. Where methods have been developed in-house, the data obtained from the validation process is then used to establish system suitability criteria for the routine application of the method.

Unless otherwise agreed with the customer, we will work in accordance with the ICH requirements: "The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. In practice, it is usually possible to design the experimental work such that the appropriate validation characteristics can be considered simultaneously to provide a sound, overall knowledge of the capabilities of the analytical procedure".

For more information on any of our services you can get in touch using our Contact Form