We Develop Visual Inspection methods that are defendable to auditors from world’s agencies. Our attention to detail had proven to minimize the human inspection variability by addressing important control measures and as such lowering variability in the inspection process.
Biothermal LLC, Visual Inspection Division offers turn key automatic inspection of product for different product format including liquid and lyo products. As part of the inspection package, we create the defect kit, perform engineering study to ensure a robust recipe is in place before performing the operational qualification of each recipe. Once the acceptance criteria is met and approved, we will run your product through our automatic inspection machine inspecting for particle and cosmetic defects then return the product ready for labeling and the defects, ready to destroy. All the documentation including reports, printouts, batch record, protocols, etc. are returned with the product shipment.
Biothermal LLC serves visual inspection needs by providing defect kit preparation, visual inspection training and certification of inspectors, Knapp studies coordination, development of visual inspection programs, commissioning and qualification of automated and semi-automated vision inspection equipment, product and mechanical samples filling in an enclosed environment.
We’ve performed the qualification efforts ahead of time, saving you time and money.
As part of our turnkey inspection service, we create a defect kit tailored to your process and in accordance with USP-790. Perform engineering studies for recipe development. Once a positive results are obtained after the engineering studies, we perform an operational qualification to qualify the recipe, After the recipe is qualified, we execute a performance qualification using your product.
The recipe qualification comes with every engineering study report, operational qualification report, equipment setting report, defect kit certificate of compliance, etc.
Biothermal LLC Visual Inspection Division has capabilities to perform automated visual inspection on the following container formats:
Our product fill service includes container filling, stoppering, and crimping. This is performed in and enclosed system and under heap filtration, eliminating contamination.