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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