Product manufacture in AZ’s Large Scale Lab encountered a significant negative trend in yield and increased impurity for a particular product. A three-hour Britest session identified 14 potential corrective actions covering chemistry, engineering and analysis. By systematic testing, the root cause (oxygen ingress) was identified. By improving vessel purging AZ were able to reduce impurity to 2% and increase the yield from 50% to 70%. Successful manufacture corresponded to $250K of cost deferred.
Analytical scientists at AstraZeneca were able to rapidly and effectively identify and eliminate subtle procedural variations in a test method being used to make product quality decisions with significant cost implications for any batch wrongly rejected. Britest tools were used to visualise the sample preparation regime in detail, breaking it down to identify potential sources of variation, and prioritise these for further investigation in a factorial experimental design. Re-wording the test method restored the method to control, saving $10-50k per out of specification result prevented.
An example of how a Britest study enabled one of the world's leading formulators, manufacturers and marketers of fuel and lubricant additives to gain a fundamental understanding of the influence of raw material composition and process conditions on the properties of a free-radically produced polymer which wasn't always hitting the mark. Having identified an issue in a critical raw material, Infineum were able to agree a new monomer specification with their supplier and save £350k a year.
Read how the use of the Britest tools and approach encouraged chemists and engineers in a large manufacturing organisation to address a problem in pressure filtration which had been dragging on for three years - saving the business £500K a year.
Read how a Britest problem solving study rapidly enabled a major pharmaceutical manufacturer to get a controlled release drug capsules product back to target release profile after transferring the process to new manufacturing equipment.
A large pharmaceutical manufacturing Britest member had identified processing issues associated with a micronisation step during late stage development with several new drug candidates intended for inhalation. A multi-disciplinary, cross-site team was put together which used Britest tools to identify key material attributes, equipment and process parameters impacting upon the micronisation unit operation. With the root causes identified the team was able to define a generic workflow and guidance for successful micronisation in the future.