1.0 OBJECTIVE
To provide a guideline for operation, cleaning and calibration procedure of Homogenizer.
2.0 SCOPE
This SOP is applicable for the operation, cleaning and calibration procedure of Homogenizer (Model No.: POLYTRON PT-MR 6100 D/230V) at Quality Control Department (Company Name).
3.0 RESPONSIBILITY
3.1 Operating personnel in the laboratory is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the Head of QC or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Before pushing up the slider of the coupling, hold your dispersing aggregate in one hand avoiding the aggregate to fall down when pushing up the slider.
5.2 When replacing an aggregate the line card has to be disconnected from the power supply.
5.3 At long term use of high loads, the aggregate & coupling can heat up to high temperature levels- danger of skin burn.
5.4 Never immerse the upper coupling head and upper hole of the dispersion aggregate
6.0 PROCEDURE
6.1 Mount a dispersing aggregate into the coupling
6.2 Plug in the main cable to your power supply.
6.3 Turn the drive on using the main switch.
6.4 Immerse the aggregate in the product.The optimum depth of the dispersion attachment is about 70% of the total depth of product in the container.
6.5 Adjust speed using ▼/▲ key on the drive unit.
6.6 To start operation press START. Motor will start rotating.
6.7 To stop, press STOP. Motor will stop, Target speed value will be saved.
6.8 Machine can be operated using Software after installation it. A method with time-speed program and temperature range is to be created before start operation.
6.9 For making a time-speed program select profile and enter desired/target value.
6.10 To erase a profile, click RESET-button.
6.11 To make a temperature range click on TEMPERATURE LIMITS. Enter Maximum and Minimum temperature. As far as the product temperature gets outside of the min/max range the drive stops. Finally save the method.
6.12 During operation, open the method, immerse the aggregate in the product and click on PROFILE button.
6.2 Operation logbook
6.2.1 Record the informations in the operational log book- “LOG BOOK OF HOMOGENIZER” as per FRM No.: FQC/446.
6.3 Cleaning
6.3.1 To clean the plastic surface a cloth moistened with non-corrosive liquid should be used.
6.3.2 To clean the dispersing aggregate, operate it with the diluents and finally water.
6.4 Calibration
6.4.1 Ensure that the instrument is clean before use, including surrounding area.
6.4.2 Check and ensure due date of calibration.
6.4.3 Operate the Homogenizer as per procedure.
6.4.4 Switch ON the power supply.
6.4.5 Set the target speed 15000 rpm, 20,000 rpm and 25,000 rpm
6.4.6 Check the target speed with a calibrated tachometer.
6.4.7 Immerse the temperature probe into a solution and operate the drive unit.
6.4.8 Press the loop button and check the temperature monitored by the machine and compare with a calibrated thermometer reading.
6.4.9 Record temperature three times.
6.4.10 Also check the timer by setting following program.
Time 0 5 10 20
Speed 10,000 15,000 20,000 25,000
Press on profile and record the transferring time programmed by using a calibrated thermometer.
6.4.11 Record all the observations in the Calibration report (Annexure –II).
6.4.12 After completion of calibration switch ‘OFF’ the main supply.
6.4.13 If the acceptance criteria for calibration are not satisfied, then follow the procedure for Handling of Out of calibration for instrument & equipment (SOP No.: QA049).
6.4.14 After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
6.5 Calibration Frequency
6.5.1 Every year ± 10 days of due date and after maintenance job.