Method Validation

Our validation department regularly performs identification and routine method validation work as well as engaging in a wide range of bespoke R&D projects, such as claims support regarding antimicrobial efficacy, proof of concept, and challenge testing.

We perform the following routine testing:

• Biological indicator enumeration
• Preservative efficacy
• Microbial identification
• Process validation
• Cleaning validations (medical devices)
• Determination of bioburden method recovery efficiency

Additionally, the validation department performs validation and method suitability testing of the methods utilised in our Quality Control testing procedures as well as quality checks of all the media prepared in house.

Log reduction testing

One of the regular types of projects the validation department is involved in are those designed to assess the antimicrobial effectiveness of wound dressings as compared to a market leader (predicate device). In these projects, novel dressings were compared using a log reduction test where an inoculation was made to a number of dressings and then tested over a defined period to monitor the log reduction over time.

Our validation department has extensive experience with testing on silver ion technology in wound dressings. Additionally, we have provided data to support claims of antimicrobial activity on coated devices, photo-activated plastics and biofilm reduction products.

Please continue on to any of the pages in the sidebar for more information regarding the range of validation testing our technicians can provide. More information regarding our expertise in method validation and development support is also available via our webinar: ‘Best Practice in Validating Methods for Use in Pharmaceutical Product Testing‘.