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

• Glass beads refractive index: 1.520
• Absorption: 0.00
• Model: Single mode, Fine powder.

Labels Tab

• Sample Gates: 10mm
• Enter the Lot number of the standard and the Serial number of the sampler

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-second measurement time specified. This may be adjusted to allow for local conditions.

ALSO READ: SOP for Operation of Malvern Particle Size Analyzer

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

• Glass beads: Refractive index 1.52
• Absorption: 0.00
• Dispersant: water, Refractive index: 1.33
• Model: Single-mode spherical
• Calculation sensitivity: Enhanced

Measurement Tab

• Background/measurement time: 15 seconds.
• Measurement time: 15 seconds.

Sampler settings Tab

Pump / Stirrer speed: 3000rpm

ALSO READ: Particle Size Determination Methods for Tablets Powder

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,

ANNEXURE

Annexure 1: Calibration of Malvern Particle Size Analyzer.

REVISION HISTORY

Nil

ALSO READ: SOP for Calibration of Dissolution Test Apparatus (Make: LAB INDIA)