Symetix has launched an optical inspection system for solid-dose pharmaceuticals, with a particular emphasis on softgel capsules.
The pharmaceutical business unit of US automation systems manufacturer Key Technology says the new OptyxSG/P model will help softgel manufacturers to effect a "paradigm shift" as they strive to automate their production lines, replacing batch processes with continuous processing.
Automating inspection with OptyxSG/P enhances product quality and improves production-line efficiency while significantly reducing labour costs, Symetix claims.
OptyxSG/P shares some characteristics with the Optyx/SG system introduced by the company for nutraceutical manufacturers in 2005. It also includes software enhancements to bring the new model into compliance with the US Food and Drug Administration's (FDA) 21 CFR Part 11 regulations for the use and submission of electronic records.
The OptyxSG/P system inspects each softgel capsule at speeds of up to 1 million capsules per hour, identifying and removing defects and foreign capsules from the product stream. Proprietary colour camera technology, with four primary inspection cameras located above and below the product stream, is used to check the softgels' colour, size and shape against product specifications.
Symetix image processing technology quickly analyses the product images, comparing each object with predefined standards for acceptance or rejection. When defective or rogue capsules are identified, a close-coupled, high-speed ejector system is activated and removes them from the acceptable product stream.
The OptyxSG/P also features a parallel processor that enables operators to monitor images of every object of interest processed by the system. Product flow is halted when a rogue object is encountered. All of these rogues are then presented to the operator and stored in the batch log file.
With ultra-high resolution, OptyxSG/P reliably detects and removes foreign capsules as well as the slightest defects in colour and shape, including air bubbles, stained capsules and misshapen product Symetix says. Unlike manual inspection, the system is objective and consistent, improving final product quality and cutting the risk of contamination by minimising human contact with the capsules, the company adds.
The OptyxSG/P also boosts product yields by minimising the removal of acceptable product, a common drawback with manual inspection, Symetix notes. According to the company, the new model can pay for itself in as little as one year based on labour savings alone.
Software enhancements to ensure compliance with 21 CFR Part 11 include secure and encrypted logs, secure password management, a Freeze on Reject feature, parameter histograms and guided changeover.
If necessary, Symetix points out, softgel manufacturers in transition from batch to continuous processes can batch feed the bulk-to-bulk OptyxSG/P for the time being and later integrate it with other Symetix Continuous Softgel Finishing Line components to achieve a fully automated, high-throughput finishing line system.