9. Documentation One (1) hard copy and one (1) electronic copy of the documentation package is provided as standard The documentation is provided in the English language and is designed to meet the applicable cGMP and GAMP 5 standards and testing The following lists the standard documentation – see Section 11.3 Accessory Category - Documentation for additional optioned documents • Operation and maintenance manuals • Recommended Spare Parts (RSP) list • Mechanical Bill of Materials (BOM) - serial numbers, model numbers, certifications, ranges and additional information • Instrumentation calibration records - as provided with vendor documentation
• Chamber drainability report • Material Test Reports (MTRs) • Weld Maps and Weld Logs including qualification and inspection records • Inspection test results, reports and certificates • Component vendor documentation • As-built General Assembly (GA) drawings • As-built Process and Instrumentation Diagram (P&ID) • As-built electrical drawings
10. Product Options
10.1 Door Configuration The Double Door option adds a second door to the cabinet washer system for a pass-through configuration where load (dirty) side and unload (clean) side operations are physically separated by the cabinet washer system In addition to the operator interface described in Section 7.4.4 Load Side Operator Interface , this option adds additional unload side interfaces as well as the necessary controls: • Unload side operator interface components − One (1) Allen-Bradley PanelView TM Plus 7, 7" color touchscreen HMI − One (1) Illuminated e-stop − One (1) Alarm horn • One (1) Pneumatic solenoid valve • One (1) Pressure regulator • One (1) Low pressure switch The required service panels are installed on the unload side of the system Controls interlocks are established to prevent both doors being open simultaneously 10.2 System Configuration The Left Handed option can be chosen for a left handed opening of the door with HMI and operator interfaces on the right side of the system when facing the load side This layout is a mirror image of what is shown in Section 5 Physical Size & Layout
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