The basic considerations:
- Mixing devices, like homogenizers, high-speed stirrer, for oil and waer phases of emulsion
- Packaging of IV emulasion in the infusion bottles: purging of nitrogen gas into the bottles while capping
- Sterility maintenance: use of autoclave sterilization
- Particle size uniformity because presence of droplet size > 5 micrometers leads to embolism in the blood vessels.
•The weight sheet:
- clearly identifies the chemicals required in a batch.
- presents the chemicals in the quantities and the order in which they will be used
- prevents confusion the names and identifying numbers for the ingredients should be used on batch records.
•Precise and explicir process directions are given.
•Batch record provides:
3. In-process specifications
4. Finished product specifications
•Various specifications like addition rates, mixing time, mixing speed, heating, and cooling rates, temperature, storing of the finished product samples are mentioned in the batch record directions.
•A manufacturing procedure is written by the actual operator with current knowledge and experience.
P/S: Answers asked from group supervisor =P