Calibration of centrifuge machine, Purpose :
Calibration of centrifuge machine, The purpose of this SOP is to describe the operation, calibration and cleaning of Centrifuge Machine (Model: Thermo Scientific Heraeus, Biofuge Primo), used to get supernatant from a suspension using centrifugal force.
Calibration of centrifuge machine, Scope :
This procedure is applicable for Centrifuge Machine (Model: Thermo Scientific Heraeus ,Biofuge Primo), installed in the quality control laboratory of XX Pharmaceuticals Limited
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]QC: Quality Control.
[][]RPM: Rotations per minute
Responsibilities:
The roles and responsibility is as follows:
Sr. Executive/Executive, QC
[][]To ensure that the instructions of this procedure are correctly followed.
[][]To ensure cleaning of centrifuge machine maintaining safety rules.
Manager, Quality Control
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.
Head of Quality Assurance
[][]Approval of the SOP
[][]To ensure the overall implementation of the SOP.
Procedure:
[][]General precautions or operational safety:
[][]Laboratory coat and safety glasses must be worn while handling the instrument.
[][]Ensure that the main switch and power supply connector are accessible during use.
[][]Remove the plug from the main socket during cleaning.
[][]Ensure use of rubber cushions for glass tubes.
[][]Balance centrifuge tubes equally.
[][]Never set the speed beyond the maximum limit.
[][]Do not operate the machine at the maximum RPM without a load.
[][]Tube materials must be compatible with solvent being used.
[][]Use only correctly fitting tubes.
[][]Never use a tube with leak or even crack.
[][]Spillage must be cleaned up immediately.
[][]Do not use centrifuge until reported faults are repaired.
Operation:
[][]Ensure the equipment is clean, calibrated and placed in a balanced surface.
[][]Switch ‘ON’ the mains.
[][]Switch ‘ON’ the instrument at the back of side. The switch lamp will be illuminated.
[][]Open the upper lid by releasing the lock using ‘ ‘ key and lifting it up.
[][]Prepare the samples and transfer the solution to the centrifuge tubes having similar size.
[][]Fill the solution in such a way that liquids in all tubes are in same level.
[][]Place the centrifuge tubes in the compartment provided for them.
[][]Place them symmetrically to the rotor axis for proper balancing at the time of rotation to prevent machine movement.
[][]Put a blank with the same liquid level for balancing, when it is required to centrifuge only one sample.
[][]Close the lid properly.
[][]Set RPM by using ‘▼▲’ key. Minimum of 300 rpm and maximum of 15000 rpm can be set.
[][]Then set Timer by using ‘▼▲’ key. The timer shows time between ‘1 min’ to ‘9 hr 59 min’.
[][]Start the instrument by pressing ‘►’ key.
[][]After completion of the centrifugation time the motor will automatically cut off and rpm will come down to 0 and the display reads “End”.
[][]If timer is not set, switch ‘OFF’ the equipment by pressing the red ‘■’ key.
[][]Open the lid by pressing ‘ ‘ key.
[][]Manually stop the centrifuge at any time by pressing red ‘■’ key.
[][]Switch ‘OFF’ the mains when not required.
Calibration:
[][]Calibrate the centrifuge machine once in a year.
[][]RPM calibration
[][]Switch ‘ON’ the mains.
[][]Switch ‘ON’ the instrument at the back of side.
[][]Set the desired RPM using RPM setting key.
[][]Check the RPM and record in the calibration information sheet for Centrifuge Machine (as per Annexure-I).
[][]Time calibration
[][]Switch ‘ON’ the mains.
[][]Switch ‘ON’ the instrument at the back of side.
[][]Set the desired time using time setting ‘▼▲’ key.
[][]Check the time using a calibrated standard timer and record the time in the calibration information sheet for Centrifuge Machine as per Annexure-I.
Cleaning procedure
[][]Clean the instrument once in a week or when required.
[][]Pull mails plug before cleaning.
[][]Clean the casing of the instrument with dry cotton cloth at first.
[][]Clean the casing, the rotor chamber, the rotor and the accessories regularly and in case of need with mild agents of pH values ranging from 6 to 8.
[][]Immediately after cleaning, dry the aluminum parts or put them into a warm-air dryer at a temperature not exceeding 50°C.
[][]After completion of each analysis, wash the centrifuge tube as per glass ware cleaning procedure
Annexure
Annexure-I: Calibration Information Sheet for Centrifuge Machine.