اجراء لشركة ادوية

Elsanhouty Pharma Notes, Cairo, Egypt.
Standard Operating Procedure

Dr. Hasan Elsanhouty
Document Title Coating spray gun calibration / Pattern test Page 1 of 9
1. Objective
1.1. To define the general requirements for an effective calibration control system to ensure
that coating spray guns are calibrated and maintained within accuracy limits sufficient for
their intended purpose.
1.2. Calibration of spray guns is a test of the accuracy of the gun in terms of spray rate and
to ensure that there are no significant differences between each gun and the other.
2. SCOPE
2.1. This procedure is applicable for calibration of coating spray guns.
3. RESPONSIBLITIES
3.1. Follow up: Concern Department Officer/Executive
3.2. Production: preparing the coating machine spraying guns and the solution.
3.3. Quality Assurance: To approve the SOP & calibration planning and execution.
4. PREREQUISITIES
4.1. All persons involved with the transfer of the chemical must wear overalls, protective
gloves and goggles as a minimum.

4.2. wear a suitable respirator and ear protection.
4.3. All spray equipment must be properly calibrated to ensure accurate application of the
compound.
5. PROCEDURES
5.1. Prepare a measuring cylinders equal to spraying guns quantities and measuring as it
is easy to know the quantity.
5.2. Prepare a known volume solution to be used in spraying guns calibration.
5.3. Connect the pump to the solution tank and turn on the pump until the solution is
delivered to each gun.
Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Contact No: +20 01023481152 Email:Elsanhouty2018@gmail.com

5.4. Put a measuring cylinder under each gun to measure the amount of solution sprayed
during the testing time intervals.

5.5. Using a calibrated stopwatch, starting the spraying at high, medium and low speed of
spraying pump.
5.6. Using a calibrated stopwatch, starting the spraying at high, medium and high speed of
spraying pump.
5.7. At each speed of the spraying pump, find out the volume that was sprayed at the
specified time intervals and determine the final amount sprayed per time for high,
medium and low speed.
5.8. Variation in amount of the volume sprayed by each gun shall be within the acceptance
criteria determined in batch manufacturing records.
5.9. Variance between the spraying guns may be occurred due to:
5.9.1. Worn out in solution intake hoses.
5.9.2. Worn out in gun gaskets.


5.9.3. Appearance of air bubbles in solution.
5.9.4. Solution does not dissolve.
5.9.5. Sedimentation occurred inside the hoses.
5.9.6. Worn out or leakage in compressed air hoses attached to gun.
5.10. Defects in tablets may occurred due to spraying variance:
5.10.1. Color variation
5.10.2. Over wetting

5.10.3. Sticking


5.10.4. Roughness
5.10.5. Twinning


5.10.6. chipping
5.11. Pattern test for spraying guns:
5.11.1. It is a test to distribute the solution on the tablets properly so that there is no
over wetting or there is a part of the tablets to which no solution reaches.

5.11.2. Prepare a white paper and put it under the guns “adjust distance between the
white paper guns like as that between guns and tablets in routine working” and
visually determine the efficiency of spraying on the white paper.




5.12. Atomizing air test for spraying guns:
5.12.1. Atomizing air test It is the air responsible for pumping the solution and delivering
it to the tablets, and it also controls the size of the droplets, which are the drops
of solution that will fall on the tablets.
5.12.2. If the value of the atomizing air is increased, the size of the droplets decreases, the
value of the atomizing air is reduced, the size of the droplets increases.
5.12.3. Prepare a white paper and put it under the guns “adjust distance between the
white paper guns like as that between guns and tablets in routine working” and
visually determine the droplets on the white paper.
5.12.4. In case of increasing of solution droplets the following defects may occurred:
5.12.4.1. Over wetting
5.12.4.2. Sticking
5.12.4.3. Twinning
5.12.5. In case of Decreasing of solution droplets the following defects may occurred:
5.12.5.1. Chipping
5.12.5.2. Droplet drying / volatility




6. DEVIATION:
6.1. If any deviation / incidents observed in the spray gun calibration shall be discussed and resolved
as per relevant SOP and shall be recorded during calibration.
7. CHANGE CONTROL:
7.1. If any change is done during the calibration of spraying guns, it shall be as per relevant change
control handling SOP


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Elsanhouty Pharma Notes, Cairo, Egypt.

Standard Operating Procedure

their intended purpose.

gloves and goggles as a minimum.

is easy to know the quantity.

5.2. Prepare a known volume solution to be used in spraying guns calibration.

delivered to each gun.

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

during the testing time intervals.

criteria determined in batch manufacturing records.

5.9.1. Worn out in solution intake hoses.

5.9.2. Worn out in gun gaskets.

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

5.9.3. Appearance of air bubbles in solution.

5.9.4. Solution does not dissolve.

5.9.5. Sedimentation occurred inside the hoses.

5.9.6. Worn out or leakage in compressed air hoses attached to gun.

5.10. Defects in tablets may occurred due to spraying variance:

5.10.1. Color variation

5.10.2. Over wetting

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

5.11. Pattern test for spraying guns:

over wetting or there is a part of the tablets to which no solution reaches.

visually determine the efficiency of spraying on the white paper.

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

5.12. Atomizing air test for spraying guns:

of solution that will fall on the tablets.

visually determine the droplets on the white paper.

5.12.4.1. Over wetting

5.12.5.2. Droplet drying / volatility

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

Standard Operating Procedure

as per relevant SOP and shall be recorded during calibration.

control handling SOP

Elsanhouty Pharma Notes Dr. Hassan Elsanhouty

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