SOP on Calibration Procedure for Disintegration Test Apparatus
Objective :To lay down procedure for Calibration of Disintegration Test Apparatus.
Scope :This standard operating procedure is applicable for formulation plant of pharmaceutical company name with Location.
Make: Electro lab.
Responsibility
Trained worker / Operator shall be responsible for operating of the equipment as per this SOP.
Production Supervisor / Officer shall be responsible for implementation of this SOP.
Head-Production / designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
SOP – Standard Operating Procedure
QA – Quality Assurance
Procedure
Calibration for number of oscillations per minute :
Take a pre-calibrated stopwatch. Operate the apparatus as per SOP. Start the apparatus and stopwatch simultaneously and count the number of oscillations per minute.
Repeat the same for five times and note down the number of oscillation per minute for each time.
The Oscillation per minute shall be within the limit of 29 to 32 through a distance of 53 to 57 mm throughout the period of operation. Record the observation in Annexure-1.
Calibration for temperature :
Switch on apparatus and press Key.
Turn on the heater by pressing ‘ON’ key.
Set the bath temperature by pressing scroll keys.
Wait till the temperature of Beaker A and Beaker B attain the set value.
Screen shall show the set temperature of bath and the temperature of Beaker A and Beaker B.
Take a pre calibrated thermometer and check the temperature of Beaker A and Beaker
Record the observation in Anexure-1.
Timer Calibration :
Set the timer for ‘30 minutes’ and start the equipment and stop watch simultaneously. Note down the stop watch reading immediately when the equipment stops and note the observation in Annexure-1. Observed time should not deviate by ‘± 1 min’ of set time.
Sieve Integrity Test :
Check the ‘Integrity’ of woven stainless steel cloth (sieve) attached to the base plate of each basket with a pre calibrated vernier caliper. The sieve has weaven squares of aperture of 1.8 – 2.2 mm and wire diameter of 0.57 to 0.66 mm. Note the observations in the Annexure-1.
Affix the ‘CALIBRATION STATUS’ tag duly filled and signed on the equipment after completion of calibration.
If the instrument is out of calibration then affix ‘UNDER MAINTENANCE’ tag and inform to maintenance department.
The frequency for calibration of Disintegration Test apparatus shall be after every one month or after every maintenance work.
Forms and Records
Disintegration Test Apparatus Calibration Record-Annexure-I
Distributions
Master Copy -Documentation Cell (QA)
Controlled Copies -Production and Quality Assurance
History
| Date | Revision
Number |
Reason for revision |
| – | 00 | New SOP |
Annexure-I
DISINTEGRATION TEST APPARATUS CALIBRATION RECORD
Equipment ID :
Frequency of Calibration: Monthly
Calibrated Stopwatch ID No. :
Certificate No. : Certificate Valid up to:
Calibrated Thermometer ID No.:
Certificate No. : Certificate Valid up to:
Calibrated Vernier Caliper ID No.:
Certificate No.: Certificate Valid up to:
| PARAMETERS | PARAMETERS SET | PARAMETERS OBSERVED | ACCEPTANCE LIMITS | ||
| A | B | ||||
| Oscillations/ minute
( Basket ) |
—– | 29 to 32 Oscillations/minute | |||
| Stroke Length
( Basket ) |
—– | 53 mm to 57 mm | |||
| Temperature on Thermometer | Bath | 37.0°C | 35°C to 39 °C | ||
| Beaker |
|
||||
| Temperature Displayed on the screen | Bath | 37.0°C | |||
| Beaker |
|
||||
| Timer | 30 minutes |
± 1 Minute |
|||
Sieve Integrity:
|
SIEVE No. |
BASKET A |
BASKET B |
||
|
Mesh Aperture ( 1.8 mm to 2.2 mm) |
Wire Diameter ( 0.57 mm to 0.66 mm) |
Mesh Aperture ( 1.8 mm to 2.2 mm) |
Wire Diameter ( 0.57 mm to 0.66 mm) |
|
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
CALIBRATION STATUS: OK / NOT OK
Calibration Date: Calibration Due on:
Calibrated By: Checked By:
Date: Date:
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