In this post Standard Operating Procedure Cleaning, Daily Calibration, Monthly Calibration and Operation of Weighing Balance (Make-NAPCO) in Pharmaceuticals is describe.
1.0 OBJECTIVE:
To lay down a procedure for Cleaning, Daily Calibration, Monthly Calibration and Operating procedure of weighing balance (Make-NAPCO).
2.0 SCOPE
This procedure is applicable to Cleaning and Operation of Weighing Balance in Production department.
3.0 RESPONSIBILITY:
Technical Associate: Cleaning and Operation. Officer/ Executive Production/IPQA: Supervision Head
Production: SOP Compliance.
IPQA: Line clearance.
4.0 DEFINITION(S):
NA
5.0 PROCEDURE:
5.1 Cleaning:
5.1.1 Ensure that electric connection switch ‘OFF’ to the balance.
5.1.2 Clean the platform with clean wet lint free cloth followed by dry lint free cloth.
5.1.3 Clean the main body of balance with dry lint free cloth.
5.2 Calibration Of 3100 g balance:
5.2.1 Key Board Operation:
5.2.1.1 TARE key function:
5.2.1.2 To set the zero display.
5.2.1.3 To enter the tare weight.
5.2.1.4 To cancel the tare weight.
5.2.1.5 CAL for calibration.
5.3 General Calibration:
5.3.1 Ensure the cleanliness of the balance.
5.3.2 Check the spirit level and rectify if necessary. If not in order correct it by adjusting the base screws. Record it in respective annexure as ‘OK’/ ‘NOT OK.
5.3.3 Press the power to switch ‘ON’ the balance and display shows 0.00.
5.3.4 Select the standard of checking the eccentric accuracy for balance based on capacity as mentioned below.
5.3.5 Place standard weights at five different platform for checking the eccentric accuracy of balance and record the same in ANNEXURE-II
5.3.6 Display weight at five location shall be approximately same. Reading observed on balance should not vary more then the ± 0.1 % of standard weight.
5.3.7 If the result are exceeding the acceptance limit affix the ‘‘OUT OF CALIBRATION’’ label and inform to maintenance department for necessary action.
5.3.8 Ensure that standard weight are certified by measure department.
5.4 Daily Calibration:
5.4.1 Operate the balance as per step no. 5.3
5.4.2 Put the standard weight on the platform as per mentioned table for balance.
5.4.3 Place the standard weight of 30.00 g, 600.00 g, 1500.00 g, 2400.00 g one by one on platform/pan and check the readings.
5.4.4 Record the reading in respective format as given in Annexure-I.
5.4.5 A balance is considered satisfactory for use if reading are found to be within acceptable limit of balance for as mentioned in respective Annexure for a balance and place ‘CALIBRATION TAG’ as per SOP.
5.4.6 If the readings are exceeding the acceptable limit, write remark as ‘GENERAL CALIBRATION REQUIRED’. Perform the general calibration and daily calibration. If then also balance do not measure weight within acceptable limit affix ‘OUT OF CALIBRATION’ tag as per SOP.
5.4.7 Do not use the balance till problem is not rectified.
5.4.8 After rectification, re-calibrate the balance (Daily and Eccentricity) before use and enter the same in respective Annexure.
5.4.9 Check for the zero error as per specific operation procedure of balance and enter the reading in the respective Annexure for balance.
5.4.10 Use the standard weight duly certified by the weight and measure department.
Frequency: 1. Daily calibration of balance to be done daily in morning.
2. General calibration of the balance to be done after every month, when daily calibration fails or after maintenance activity.
Note: The standard weight used for calibration of balance should be cleaned with dry lint free cloth and are to kept in weight box/trolly
Operation
5.4.11 Ensure the cleanliness of the balance.
Check the spirit level and rectify it if necessary. If not in order rectify it by adjusting base screws given.
5.4.12 Ensure the zero reading on screen before any weighing. Place the entity on platform, the balance will measure the weight of entity and display it. Weight till reading on screen will stabilize and then remove the object.
5.4.13 Turn ‘OFF’ after end of working day.
5.5 Precaution
5.5.1 Keep the machine on stable surface.
5.5.2 Ensure no strong wind drift/wind current.
5.5.3 Don’t put any object on balance till it is in ‘OFF’ position.
5.5.4 Warm up the machine for 15 minutes before operation.
5.5.5 Don’t apply any solvent for cleaning the scale.
5.5.6 Avoid to apply the overload, it may damage the load cell permanently.
6.0 ABBREVIATION (S):
SOP: Standard Operating Procedure. g: gram
7.0 REFERENCE(S):
SOP: Status labeling
8.0 ANNEXURE (S):
Annexure-I: For daily Balance Calibration (Capacity-3100 g)
Annexure-II: For Balance eccentricity Inspection record (Capacity-3100 g)
9.0 DISTRIBUTION:
Master Copy: Quality Assurance
Controlled Copy (s): Production Department, Quality Assurance
Reference Copy (s): Production Department
ANNEXURE I
Daily Balance Calibration Record (Capacity-3100 g) Make: NAPCO
ANNEXURE II
Balance Eccentricity Inspection Record (Capacity-3100 g)