The FDA 21 CFR part 11 compliant OptyxSG/P automatically inspects each softgel capsule at high production speeds and identifies and removes defects and foreign capsules from the product stream. OptyxSG/P features a new parallel processor that stops product flow when a rogue object is encountered, and all the objects that are classified as rogues are presented to the operator and stored in the batch log file. Software enhancements for FDA 21 CFR part 11 compliance include: secure and encrypted logs, secure passcode management, a Freeze on Reject (FOR) feature, parameter histograms, and guided changeover. A number of new self-aware features include Eject Function Confirmation (EFC) and intelligent sensing for belt speed, belt tracking, proper change parts, and failure of any system lamp or ejector valve.
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