Mechanical Calibration Protocol for Dissolution Apparatus

INSTRUMENT	Dissolution Test Apparatus
Refer SOP No.	DQC-SOP-0612
Model No.	EDT 14 Lx
Instrument ID. No.
Make	ELECTROLAB
Frequency	Quarterly “- 5 Days”
Date of Calibration
Next Due Date

1. Visual Inspection of Vessel, Basket and Paddle :

Vessel Examination:

Vessels shall be checked visually for the chipping, Plastic/glass vessels shall be checked for the scratching and Baskets and Paddles for the distortion.

Conclusion: found satisfactory / Not satisfactory.

Basket Examination:

Each Basket shall be visually examined for defects such as rusting, the edge of the wire mesh sticking out beyond the Basket, Clogged Mesh Holes and smashed in mesh sides.

Conclusion: found satisfactory / Not satisfactory.

Paddle Examination:

Each Paddle shall be visually examined for defects such as rusting and loose pieces of coating sticking out from the Paddles.

Conclusion: found satisfactory / Not satisfactory.

2. Calibration of Rotation per Minute (RPM) :

[Calibrated Digital Tachometer ID: _________________________] [Valid up to: _______________]

Sr. No.	Set RPM	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	50
2	100
3	150
4	200
5	300

Acceptance Criteria: ± 1 Rotation per Minute (RPM).

Done by:                                                                    Checked by:

3. Calibration of Temperature :

A. Water Bath Temperature Calibration:

[Calibrated Thermometer ID: _______________] [Valid up to: _______________]

Sr. No.	Set Temperature	Displayed Temperature (°C)	Actual temp. in Water bath (Calibrated Thermometer) (°C)	Difference	Remarks
1	35.0 °C
2	37.0 °C
3	39.0 °C

Acceptance Criteria: The Difference between Calibrated Thermometer temperature and displayed temperature should Not More Than ± 0.5 °C.

Done by:                                                                    Checked by:

B. Calibration of Jar Temperature :

[Calibrated Thermometer ID: _______________] [Valid up to: _______________]

Place the vessels containing 500mL of water (at room temperature).

Set the temperature to 37.0°C.

Allow the instrument to stabilize. Verify the temperature in each fourteen vessel.

Set Temperature: 37.0 °C

Jar No.	Displayed Temperature (°C)	Actual Temperature in Jar (Calibrated Thermometer) (°C)	Difference	Remarks
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Acceptance Criteria: The Difference between Calibrated Thermometer temperature and displayed temperature value Not more than ± 0.5 °C.

Done by:                                                                    Checked by:

4. Calibration of Time :

[Calibrated Stop Watch ID: _________________] [Valid up to: _______________]

Sr. No.	Set Time (Minutes)	Displayed Time (Minutes)	Actual Time in Stop Watch (Minutes)	Difference (Minutes)	Remarks
1	10
2	20
3	30

Acceptance Criteria: The Difference between Displayed time and stop watch should not be more than ± 5 Seconds.

Done by:                                                                    Checked by:

5. Calibration of Wobbling, Centering and D1 and D2 Distance :

Calibrated Wobbling Gauge ID: ______________, Valid up to : __________

Calibrated Depth Gauge ID: __________________, Valid up to : __________

Sr. No.	Limit of Wobbling Paddle	Limit of Wobbling Basket	Limit of D1 Distance	Limit of D2 Distance
—	NMT 0.5 mm	NMT 1.0 mm	25.0 ± 2.0 mm	25.0 ± 2.0 mm
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Where,

D1 = Distance between the bottom edge of the basket to the lowest inner surface of the vessel.

D2 = Distance between the bottom edge of the blade to the lowest inner surface  of the vessel.

Centering :

Calculate the centering using below formula;

C = Sqrt [(x₁-x₂)² + (y₁-y₂)²] / 2

 Where,

x₁, x₂, y₁ and y₂ are the distance from the inner vessel wall at four location equally spaced to shaft by vernier caliper.

Observation:

Calibrated Centering kit ID: __________________, Valid up to: ___________

Calibrated Vernier caliper ID :________________, Valid up to : ___________

Limit for Centering, c : NMT 2.0mm

Vessel	x1 mm	x2 mm	y1 mm	y2 mm	x1-x2	y1-y2	Centering, c (mm)
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Calculation: (Vessel -1):

Calculate the same for other vessel.

Done by:                                                                    Checked by:

6. Leveling Check:

By Digital protractor

[Calibrated Digital protractor ID: ____________________, Valid up to: ___________]

Verify the Bench top levelness and Base Plate (Vessel support plate) levelness. Measure the inclination on the each side (i.e. On four sides front, rear, left and right) for Bench Top and for Base plate. If leveling is not satisfactory for Base plate, adjust the level by rotating the adjusting screws on the feet of the assembly.

Observation table:

—	Front	Rear	Left	Right	Limit
Bench Top Inclination					NMT 1°
Base Plate Inclination					NMT 0.5°

Conclusion: Leveling found satisfactory / notsatisfactory limit.

Done by:                                                                    Checked by:

7. Alignment verification by Digital Protractor :

[Calibrated Digital protractor ID: ____________________, Valid up to: ___________]

Shaft Verticality:

Measure the verticality of paddle shaft and basket shaft in the dissolution assembly.

Measurement of the verticality of the stirring element.

Vessel Verticality

Measure the verticality of vessel in the dissolution assembly. Take the measurement on the vessel inner surface.

Observation table:

Shaft No. #	Paddle  Shaft Limit (90°±0.5°)	Basket Shaft Limit (90°±0.5°)	Vessel Limit (90°±0.5°)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

Conclusion: Shaft and Vessel verticality found satisfactory / notsatisfactory limit.

Done by:                                                                    Checked by:

Remark: The instrument is calibrated & qualified/ Out of calibration & not qualified for use.

Calibration: Scheduled / Not scheduled

(Reason: ___________________________________________________)

Remarks: Calibration Satisfactory / Not Satisfactory

Calibrated By (Sign/ Date)

Checked By (Sign/ Date)