1. A 30 cubic foot V-blender used in a granulation process for making Melambien in your production facility has an adjustable speed from 0-250RPM, which can be set by adjusting a dial on the control panel. The setting is automatically sent to the motors variable frequency drive, which tells the motor how fast to spin the blender. The actual blender speed is translated into a digital readout (on a display on the control panel, next to the speed adjustment dial) from the signal from a sensor at the blenders main rotating shaft.

a) Put the following RANGES in order from the widest (largest) to the tightest (smallest) in magnitude. Hint: you can make up numbers aligned with the question to prove your point please dont simply quote the definitions from the notes; I can read them just as well as you can).

• The range of rotation speed settings at which the blender should be operated, as listed in the batch record, for maximal flexibility for the operator without impact to product SISPQ
• The Edge of Failure determined for blender rotation speed
• The rotation speed range that is validated for routine operation of the blender for producing Melambien of suitable content uniformity
• The calibrated range of the blender rotation speed display (the instrument loop would be the digital display and the sensor)
• The calibrated range of the tachometer that is used to calibrate the blender rotation speed loop
• The blenders rotation speed range (as read from the digital display) that is qualified in the OQ
• The design range for blender rotation speed, as specified by the supplier, assuming the blender was properly designed and selected to meet GEMP guidance