Radiopharmaceutical Production Operating Instructions STOP

Operating Instructions Contents Supplier Operating Instruction Operator Aids The operating instructions for any piece of equipment are usually supplied by the manufacturer. There may be additional instructions which are necessary to carry out the functions required for the specific task the equipment is being used for. There may also be instructions which detail the specific way in which the equipment is being used. These are often referred to as operator aids and may be posted on or near the equipment to help the operator in using the equipment in exactly the same way every time. STOP

Supplier Operating Instructions The supplier’s technical documentation may include the following information Technical Specifications Description of the equipment Operating manual Operating instructions Functional diagram Assembly/layout plans Energy and utilities supply required Technical data sheets Specifications/certificates for lubricants, processing aids and utilities Material certificates of product contact parts Environmental conditions Alarms Maintenance procedures including intervals in operating hours or time Cleaning procedure Calibration procedure and calibration report for working calibration

Operator Aids Operator Aids can include specific instructions on the procedure to be used with diagrams or pictures to help visualize the process The operator aid can be as simple as a note to set the pressure to 20 psi on the tank regulator or as complex as the example shown at right and on the next slide for the gel method of endotoxin testing In all cases, the operator aid must be signed and dated by the person who developed and produced the operator aid.

Operator Aids These operator aids can be posted in the area where the endotoxin testing is being done.

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