SOP for Calibration of Malvern Particle Size Analyzer

PURPOSE

The purpose of this SOP is to describe the calibration of the Malvern Particle Size Analyzer (Model: APA 2000 /AWA 2001-SR /ADA 2000).

SCOPE

This SOP is applicable to the Malvern Particle Size Analyzer (Model: APA 2000 /AWA 2001-SR /ADA 2000).

RESPONSIBILITY

Analyst: Calibration of the Malvern Particle Size Analyzer as per the SOP

Quality Control Head or Designee:

Providing training to all the concerned persons before the implementation of SOP.
Ensuring proper calibration documentation as per SOP

PROCEDURE

Calibration of Dry Analysis Method - Malvern Particle Size Analyzer:

Calibration frequency: Quarterly ± 10 days or immediately after any maintenance.

Start the instrument as per the operational procedure.
Ensure cell windows and any lenses are clean and free from scratches.
Check that the part number of the standard being used is QAS3002 to ensure correct sample loading for this measurement.
Set up the instrument with the parameter as per below

Material Tab

Labels Tab

Measurement Tab

Background / Measurement time: 12 seconds
Advanced options, Measurement tab ---> Obscuration limits: De-select Default and set limits to 0.5 & 6.
Click on the “Obscuration filtering “tab and ensure that the “Enable obscuration filtering” box is checked. Set the time-out period to 00.10

Sampler settings Tab

Sampler tray: General purpose
Air pressure: 1 Bar
Feed rate: 50 %.The feed rate is an average setting that should ensure that the obscuration falls within the specified limits and that all the sample is consumed within the 15 seconds measurement time specified. This may be adjusted to allow for local conditions.

Cycle Tab

Select a single aliquot and one measurement cycle.
Run the instrument for the particle size measurement of QAS3002 standard as per the procedure of dry analysis.
Record the results in the calibration format
The acceptance criteria are 3% of the specified limit on the Dv50 and 5% of the specified limit on the Dv10 & Dv90.

Calibration Procedure for Wet Analysis Method

Calibration frequency: Quarterly ± 10 days or immediately after any maintenance.

Start the instrument as per the operational procedure.
Ensure cell windows and any lenses are clean and free from scratches.
Flush and drain at least twice with clean water (Milli-Q) before the measurement to eliminate any contamination from previous samples.
When the dispersion unit is filled and is ready, turn the pump/stirrer speed down to zero.
Take the pump/stirrer speed up to 3000rpm and then back down to zero.
Take the speed back to 3000 rpm and top of the water in the tank if the displacement of the air has lowered the level.
Check that the part number of the standard being used is QAS3001B to ensure correct obscuration for this measurement. (bottle label: CRM0016)
Empty the entire contents of the bottle into the dispersion unit and half-fill the empty bottle with (milli-Q) water.
Replace the stopper, shake well, and add the rinse water to the dispersion unit.
Allow at least 30 seconds for the sample to circulate.
When measuring the sample, 4 drops of noni dat D 40 surfactant should be added to the tank.
Measure the sample within 1 minute of adding to the dispersion unit.
Set up the instrument with the parameter below,

Material Tab

Measurement Tab

Sampler settings Tab

Pump / Stirrer speed: 3000rpm

Cycle Tab

Select a single aliquot and 3 measurement cycles.
Run the instrument for the particle size measurement of QAS3002 standard as per the procedure of wet analysis.
Record the results in the calibration format.
The acceptance criteria are 3% of the specified limit on the Dv50 and 6% of the specified limit on the Dv10 & Dv90.
Calibration checks shall be performed by the third party for RPM indicators and Air Pressure indicators (Pressure Gauge) by their submitted SOP.
Calibration frequency: Yearly + 30 days or immediately after any maintenance
Performance check of the instrument by the Vendor, Which shall be conducted using a total of five standards (standard dry samples and standard wet samples) by the “Dry analysis method” and “Wet Analysis method”, respectively.
Calibration frequency: Yearly + 30 days or immediately after any maintenance
Performance checks shall be carried out after the following maintenance,