1. Radiopharmaceutical Production
Operating Instructions
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2. 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.
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3. 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

4. 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.

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

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