1.0 PURPOSE:
To lay down a procedure for operation, cleaning and calibration of Media Preparator.
2.0 SCOPE:
This procedure covers the operation, cleaning and calibration of Media Preparator used in Quality Control department of (Company name).
3.0 DEFINITIONS:
Nil.
4.0 RESPONSIBILITY:
4.1 Quality control chemist shall be responsible to operation, cleaning and calibration of Media Preparator and maintain the record.
4.2 Head-Quality Control or his designee to ensure compliance.
5.0 PROCEDURE:
5.1 Operating Instructions:
5.1.1 Check and ensure that the instrument is clean and free from dust if not clean, clean the media preparator with dry cloth.
5.1.2 Switch ON the instrument for set user input parameter.
5.1.3 After pressing “SET”, set dispensed volume required to dispense as 500 ml, 750 ml, 900 ml,1000 ml by using scroll keys or define from 200 ml to 4000 ml.
5.1.4 Press enter key display shows all the set parameters on display. Press F1 key to proceed with process.
5.1.5 First unit starts with the aspiration of media. At this stage make sure the aspiration nozzle is properly parked in aspiration holder and extension tube end immersed in prepared media after conformation press F1 key to proceed. As we press F1, RUN LED will glow on front panel.
5.1.6 Keep eye on media volume, which shows the current status of the media volume level. The media volume level. The media level counter continuously updates the value as media aspiration takes place
5.1.7 When media volume reached to 2 Liters, the circulation of media and heating of media will start. After the set volume for media has been reached it continue with achieving temperature, which we can observe on display screen.
5.1.8 After reaching the set temperature wait till attain the vacuum.
5.1.9 After degassing, the cooling system will bring down the temperature of the media preparator then dispense directly in to the dissolution tester bowl/jar pressing dispense button.
5.2 Cleaning process:
5.2.1 To clean the unit, select from front panel, The display shows the cleaning parameters like-clean by using 2L purified water and clean time 5 minutes, clean the vessel with programmable volume with temperature and time
5.2.2 After selecting a desired volume, temperature and time press enter for cleaning process. Display will prompt for Nozzle to be kept in cleaning solution.
5.2.3 After setup is ready, press F1 key to run the cleaning process. The display will show the value for cleaning solution volume getting incremented and achieving set temperature.
5.2.4 Soon after temperature is achieved display prompt to park nozzle in circulation holder soon after it shows cleaning cycle remaining time.
5.2.5 After the cleaning cycle is over, display will prompt to put the nozzle into the drain area.
5.2.6 After set up is ready, press F1 key to run draining process press F2 key.
5.2.7 Drain out all the media in the waste container.
5.3 Drain Process:
5.3.1 To drain the media select drain from front panel. After selection display will prompt for nozzle to be kept in a drain area.
5.3.2 After the setup is ready press F1 key to run the draining process, the display will show releasing of vacuum for fast process of drain.
5.3.3 As vacuum is released system starts with draining.
5.3.4 After drain it finally shows emptying of tube.
5.4 Verification:
5.4.1 The dispenser can be verified by user itself by taking five readings. The systems calculate the average of five reading and calibrate the pump. Validate at different user input volume level.
5.4.2 Aspirate at least 7 liters purified water. Degas the purified water with 5 minutes of degassing time and 41° C of temperature. (Degas procedure can be done with run cycle. As display prompt for ready to dispense press STOP key and abort the press).
5.4.3 Go for option menu press validate
5.4.4 Once vacuum reached system prompt for putting nozzle in the holder for priming
5.4.5 Enter the volume for validated dispense by set volume pressing F1 key.
5.4.6 Prior to that make ready of dry measuring cylinder /beaker.
5.4.7 Take weight of the measuring empty cylinder /beaker.
5.4.8 Press dispense key on handle, verification will start dispense the media (purified water) in measuring cylinder/beaker.
5.4.9 Take weight of the purified water with beaker/measuring cylinder and calculate the mL dispensed against set volume.
5.4.10 Press enter to register, display will show the percentage of deviation, if the percentage is within ± 1% then verification is done.
5.4.11 Enter he details in the Annexure-I.
5.4.12 Verification of media preparator to perform quarterly.
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
CAL : Calibration
% : Percentage
No. : Number
A.R No. : Analytical reference number
°C : Degree centigrade
7.0 REFERENCES:
Nil.
8.0 LIST OF ANNEXURES:
Annexure-I: Quarterly verification of media preparator.
