Validation Summary Report



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Facilities Qualifications Item Summary Date Status Certificate of Occupancy ISO 14644 Class 8 Clean Room Certification Facility approved for occupancy June 9, 2015 Issued Particle Count Airflow Testing July 9, 2015 Certified Material Handling Systems Operating Logic Risk Assessment July 14, 2015 Complete Material Handling Systems Vendor Installation Qualification July 24, 2015 Complete Material Handling Systems Vendor Operational Qualification August 26, 2015 Complete Material Handling Systems Vendor Performance Qualification September 2, 2015 Complete Material Handling Systems Nordson MEDICAL Qualification February 11, 2016 Complete Compressed Air System Installation Qualification April 28, 2015 Complete Chilled Water System Verification July 30, 2015 Complete Air and Water systems Balancing Report September 21, 2015 Complete Commissioning Report Facilities Mechanical Electrical June 22, 2015 Complete ISO 13485 certification Update Third Party Certification October 13, 2015 Issued see www.nordsonmedical.com/tech/index.aspx for updated ISO certifications Assembly, Packaging, Quality Equipment Qualifications Item Quality Inspection Equipment – CMM Scope Summary Date Status Calibration August 4, 2015 Complete Packaging Equipment IQ, PQ September 30, 2015 Complete Stopcock Assembly Automation Assembly Equipment IQ, PQ Ultrasonic welders, o-ring machine, automatic tubesetters th October 9 , 2015 Complete October 14th, 2015 Complete Validation Summary Report DATE: February 11th, 2016 SCOPE: Loveland Manufacturing Facility Injection Molding Machine Qualifications Item Summary Installation Qualification Machine Installation Installation Qualification Water Leak Detection Equipment Installation Qualification Servo Robot / Sprue Picker Installation Qualification Temperature Controller Operational Qualification Injection Position Calibration Operational Qualification Injection Velocity Calibration Operational Qualification Injection Pressure Calibration Operational Qualific




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