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Pharmaceutical – 21 CFR part 11

The pharmaceutical and medical device industries have been served by us since the company was founded. We can provide 21 CFR Part 11 ready solutions. The pharmaceutical and medical device industries offer an ideal application to vision systems.

Vision systems can check 100% of products, even on high speed lines, allowing statistical process control (SPC) to be used to monitor any variations in quality. Applications include print recognition and verification (OCR/V), including verification of date/lot codes, checking the presence of all components and colour checks in pharmaceutical devices.

In addition to standard vision systems, MVT is able to supply customised solutions and specialist vial readers for the pharmaceutical and medical industries . These are able to read datamatrix marks (2-d barcodes) from a complete tray of 96 vials. The advantage of this type of automated reading is that vials can be marked for their entire life. Vials are usually given a serial number that, when correlated with a database, allows the full history of the vial to be viewed.

Trials have been carried out using vision systems on tablet inspection to find damage to the outer coating, perform colour measurements and check size and shape.

OCR (optical character recognition) and OCV (optical character verification) has been carried out on pharmaceutical devices to ensure that laser printing was correctly set and completed for 18 different languages. These checks were carried out on-line and did not restrict the production line speed.