Sterility testing

Sterility testing is performed on a wide range of materials from paints, polymer dispersions and adhesives to colourants, inks and personal care products. The techniques employed can be varied to suit the application and range from simple presence / absence tests to full quantification based on the various Pharmacopeia protocols (e.g. Ph.Europ 4 Chapter 2.6.12). In many cases ranges of tests are employed and product and production quality is monitored through the use of secure on-line databases and SPC systems.

 

Contaminants can be identified in-house and profiled for tolerance to a wide range of preservatives to assess risks to products and manufacturing processes. The aim is, where appropriate, to integrate the testing into the whole quality assurance programme through customised approaches and plant audits. We have extensive experience with many manufacturing processes and understand the limitations and risks that apply and work closely with our clients to optimise manufacturing quality.