Background
A new active ingredient to Safapac was proposed to be manufactured in the form of a suspension concentrate (SC). The provided bill of materials (BOM) stated the required quantities of each component, but not a method of manufacture.
Lab to full scale
The BOM was broken down into how the separate components were to be used and whether they were to be used in intermediates or final products.
Laboratory Trial
Using our formulation development experience, a manufacturing process was devised that could be applied to large scale semi-continuous production breakdown. Laboratory trials commenced using the formulation protocol developed. Refinement was then made from the deduced laboratory findings of the small scale manufacturing results (evaluating chemical compatibility). Once the lab trial was complete , the sample underwent a storage stability protocol and samples were sent to the customer. At the end of the stability period, the samples were re-analysed and the results reported to the customer.
Plant Pilot Trial
The next stage was a pilot trial of 8,000lts – before the trial could commence, the ERP system was populated with the product information, including all the intermediates and packed products. Process risk assessments were also formalized. Subsequently pilot scale manufacture was commenced with an overview of all the processes and intermediate products. At the end of the run, samples were placed on storage stability. A post production review was carried out and any changes agreed with the customer – systems were updated with any changes.
Main Manufacture
The final stage of the SC scale up was full-scale production – this was the same as for the pilot trials, but with less overview of the process once optimum process conditions had been met.
The limited manufacturing information at the start of the project was overcome by the above 3 step procedure with the final in-process checks and manufacturing protocols put in place. The new formulation was therefore able to be made successfully meeting the customer’s registered specification.
