SOP for Operation and Performance Check of Test Sieve Shaker

Purpose

To describe the Operation and Performance check of the Test Sieve Shaker.

Scope

This procedure is applicable to the Test Sieve shaker.

Instrument: Test Sieve shaker

Make: W.S.Tyler, USA

Model: RX – 29-10

Instrument Code: 

Location: QC Lab

References

References: Instrument Operational Manual.

General monograph of “Particle size distribution estimation by analytical sieving” <786> USP.

SOP of “Maintenance of Laboratory Instrument”.

Responsibilities

Analyst: 

• Operation of the instrument.
• Performance check of the instrument.
• Recording all documents related to performance checks and maintenance.

Head Quality Control or Designee:

• To provide training to the concerned before implementation of SOP
• To ensure proper documentation as per SOP.
• To ensure the operation and performance check of the instrument as per SOP.

Head Quality Location

• To review and approve SOP.
• To implement the system as per SOP.

Quality Assurance

• To ensure the implementation of the system as per SOP.

Distribution

Quality control Department

Quality Assurance Department

Definitions of Terms

RPM – Revolution Per Minute

ALSO READ: SOP for Operation of Malvern Particle Size Analyzer

Procedure

Operational Procedure

• Switch “ON” the instrument from the mains.
• Make sure that a sieve stack is in place at the time of usage.
• Select a set of test sieve required for the analysis as per the monograph or analytical test procedure.
• Stack the test sieves (one sieve on top of the other) in such a way that the sieve with the largest mesh size shall be on the top of the stack and the sieve with the smallest mesh size shall be on the bottom.
• Put a clean and dry pan in the bottom of the sieve shaker.
• Place the sieve stack (i.e. set of sieves) into the sieve shaker and transfer the accurately weighed quantity of material as specified (Take minimum 50 gm or suitable where quantity is not specified) in the monograph or analytical test procedure in the upper most sieves.
• Place the lid on the top of the stack and ensure the cork is fixed properly. The sieves shall be secured into place.
• Set the test run time 15 minutes by, simply turn the ‘THUMB WHEEL’ + (plus) or – (minus) to the desired time in the digital window. Suitable timer also shall be used for the analysis
• Push the ‘START/STOP BAR’ to start test, the time shall be displayed on the screen.
• A last set time for the sieve analysis test shall remain in memory until the next time is set.
• After completion of the agitation, dismantle the sieve stack from the sieve shaker.
• Empty the material retained on the coarsest (largest) sieve in a big piece of butter paper. Thoroughly remove all of the remaining particles into the underside of the sieve pan.
• Weigh the material retained on each sieve and record the weights in grams.
• If required tap the sieve frame with the hand gently clean any remaining material on the sieve. Weigh the contents in the weighing dish to the nearest 1/10th gram (minimum) and record the data.
• Weigh the material passing through the finest sieve into the bottom pan to obtain the total weight for percentage calculations.
• The total weight of the material retained on the various sieves and at the bottom pan shall be extremely close to the weight of the original sample. (Total losses must not exceed 5 % of the weight of the initial weight)
• The percent retained on each sieve is calculated as follows;

Weight of material retained on a particular sieve (in gram)

= ---------------------------------------------------------------- x 100

Weight of the material taken for analysis (in gram)

• Switch “OFF” the instrument and make an entry in the instrument usage log.
• In some applications, static electricity can make test sieve analysis extremely difficult. During the sieving process, particles come in contact with each other and sometimes “charge” themselves. Once the material being tested charges itself, it may “stick” to each other or to the metal frame and mesh of the sieve, which prevents conducting an accurate analysis.
• In such cases, add a small amount of powdered magnesium carbonate, Aerosil, burgess clay, or talc to the product sample prior to testing.

• For a 100 – gram sample add approximately 1 gram of any above material. Mix thoroughly and proceed with the test.
• For the different sieving methods like Wet sieving and Air jet and sonic sifter sieving method refer USP chapter <786>.

ALSO READ: Particle Size Analysis

Cleaning of sieve

• Wash the sieves thoroughly with tap water and then with purified water to remove the material completely. If any apertures remain blocked by test particles, apply the air jet to remove them.
• If still it is not removed then use the solvent in which the test particle is soluble and then wash it with purified water. To remove the water a volatile water-miscible solvent can be used and then an air jet to remove the solvent.
• After all the above actions still, the aperture is blocked by the test particle, carefully brushing with a soft brush can be applied.

Sieves

• Sieves should be made of stainless steel or, less preferably, from brass.
• Sieves should be carefully examined for gross distortions and fractures, especially at their screen from joint, at the time of usage and shall fill the observations in attachment-1.
• In case of a sieve observed with any distortions, fractures, or opening of joints, reject the sieved and replace it.

Performance check Procedure

A. Performance check of the Sieve shaker by measuring the Tapping height:

• Switch “ON” the instrument and follow the operational procedure as described in above step.
• Set the time in seconds (about 5-10 seconds is sufficient) and push the ‘START/STOP BAR’ to start functioning of the sieve shaker.
• As soon as the ‘START/STOP BAR’ is pushed, the sieve shaker starts hammering on the cork and shaking the sieve horizontally. Immediately push the ‘START/STOP BAR’. The hammer shall stop on a maximum height position.
• Measure the height of the lift rod with the help of Vernier calipers and record the data in the Performance check log (Attachment-2)
• The analyst shall make an entry of instrument usage in the “Instrument Usage Log”
• After the approval of the Head QC, the analyst shall fill in the calibration details in the “Performance check status” label as per SOP on the “Labeling” affix on the Instrument.
• In case of non-compliance of performance check inform to Head QC or designee.

B. Performance check of the Sieve shaker by measuring the Horizontal revolution:

• Switch “ON” the instrument and follow the operational procedure as described in the above step.
• Affix a piece of reflective mark on the horizontal shaker bottom Depress the measuring button of the tachometer and align the visible light beam with the reflective mark.
• Set the time for one minute and push the ‘START/STOP BAR’ to start the functioning of the sieve shaker.
• As soon as the ‘START/STOP BAR’ is pushed, the sieve shaker starts hammering on the cork and shaking the sieve horizontally.
• The Tachometer screen shall display the value of horizontal revolution in RPM. As soon as the value gets stabilized note down this value in the Performance check log (Attachment-2).
• The analyst shall make an entry of instrument usage in the “Instrument Usage Log”.
• In case of non-compliance of performance check inform to Head QC or designee.

C. Performance check of the Sieve shaker by measuring the Tapping:

• Switch “ON” the instrument and follow the operational procedure as described in the above step.
• Set the time in minutes as specified in the Performance check log (Attachment-2) and push the ‘START/STOP BAR’ to start the functioning of the sieve shaker.
• As soon as the ‘START/STOP BAR’ is pushed, the sieve shaker starts hammering on the cork and shaking the sieve horizontally.
• Count the tapping manually by touching the scale on the hammer and note down the counted tapping in the Performance check log (Attachment-2).
• The analyst shall make an entry of instrument usage in the “Instrument Usage Log”.
• In case of non-compliance of performance check inform to Head QC or designee.

Attachments

Attachment - 1: Physical check log of sieves

Attachment - 2: Performance check log

Revision History

Nil

ALSO READ: SOP for Calibration of Malvern Particle Size Analyzer