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Why Inspect? parenteral injecton visual inspection shandong hawkeye US FDA 483 Themes

 Patient Risk  – Physiological Implications  • Particles  – Chemical and Microbiological Implications  • Particles, Container Integrity  • Compendial Requirements  – Pharmacopeias  • Regulatory Requirements  • Process Knowledge and Continuous Process  Improvement • Must establish a maximum allowable reject rate.  • Must control reinspection of product, including when appropriate, inspection conditions and number of reinspections permitted.  • Inspectors must be trained, and training  documented.  • Inspectors must be periodically requalified.  • Training and qualification conditions must align  with routine 100% inspection conditions.  • Address inspection fatigue during qualification.  • Must use statistically sound sampling plan(s) for AQL inspection.  -0086-13589838190
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EYE DROPS FMP VISUAL INSPECTION MACHINE

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vial liquid visual inspection

 visual inspection machines (shandong hawkeye) can work for foreign objects such as glass debris, aluminum chips, rubber chips, hair, fibers, etc. with a size of more than 40μm in sterile liquids online, ensuring that unqualified products are accurately rejected.  The AVI uses mechanical vision technology and automatic control principle to make the tested product rotate at high speed and brake instantly by mechanical method. Special light source system and ultra-high speed precision industrial camera are used to obtain images of the tested product series. The intelligent image processing algorithm software system independently developed by the shandong hawkeye is used to compare, calculate and analyze the images to complete the detection of the products. The detected unqualified products will be rejected through the actuator of the automatic control system.
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