1.0 PURPOSE:
To describe a standard operating procedure (SOP) for micronization where particle size specification was not provided by the customer.
2.0 SCOPE:
The SOP describes in detail the method for micronization where particle size specification was not provided by the customer.
3.0 RESPONSIBILITY:
The responsibility of micronization as per the SOP lies with the staff of rank not lower than operator of production department.
The responsibility of preparing, reviewing and approving the SOP lies with the Officer (Production), Head of Production and Head of QAD respectively.
4.0 METHOD:
4.1 Check the micronizer for any leaks as per SOPxxxxx
4.2 Apply air pressure of 6 - 7 kg/cm2 through needle valves.
4.3. Adjust the feeding pressure to 4.5 - 5.0 kg/cm2.
4.4. Adjust the grinding pressure to 3.0 - 3.5 kg/cm2.
4.5. Charge the product in vibrator feeder by using scoop and switch "ON" the electrical supply to vibrator feeder and adjust the feed rate of 3 - 4 kg/hour.
4.6. Collect the product in bowls.
5.0 RECORDING:
The micronization operation shall be recorded by the operator/supervisor in micronization record.
Production, micronization, specification