SOP’s

Operation, calibration and cleaning of different models of Balances. STANDARD OPERATING PROCEDURE Pharma Micro Hub Title: OPERATION, CALIBRATION AND CLEANING OF BALANCES SOP Number: SOP/PMH/002-00 Department: MICROBIOLOGY Effective Date: 06/04/2026 Format Number: FMT/PM/002-05 Page Number: 1 of 19 1.0 OBJECTIVE 1.1 To lay down the procedure for operation, calibration and cleaning of different models of Balances. 2.0 SCOPE 2.1 This procedure is applicable for operation, calibration, and cleaning of different models of Balances located in the Microbiology Department of AET Laboratories Private Limited. 3.0 RESPONSIBILITIES 3.1 Microbiology analyst shall be responsible to follow the procedure as per the SOP. 3.2 Quality Control / Analytical Development personnel shall be responsible for the preventive maintenance activity. 4.0 ACCOUNTABILITY 4.1 Head/Designee – Microbiology. 5.0 PROCEDURE 5.1 Preliminary Check 5.1.1 Check and ensure the balance and its surrounding areas are clean and suitable for usage. 5.1.2 Use a soft brush for cleaning the pan and its surroundings and verify the calibration status. 5.1.3 Check the spirit level of the balance; if it is in the center, proceed for operation. If not in the center position, adjust it using the leveling feet. 5.1.4 Ensure that the total weight shall not exceed the minimum and maximum operating range of the balance. 5.1.5 Before weighing, bring the temperature of the material to be weighed to room temperature, if required. 5.1.6 Display the operation range of the balance with minimum and maximum weights (e.g., Range: 10g – 500g). 5.2 Cleaning 5.2.1 Ensure the power supply is switched ‘OFF’ before cleaning or preventive maintenance. 5.2.2 Clean the pan and inside of the balance with a lint-free cloth. 5.2.3 Use a soft brush for cleaning the pan and its surroundings. 5.2.4 Make an entry in the balance instrument usage logbook after cleaning. Cleaning activity shall be entered at the start and end of the shift. 5.2.5 Precautions must be taken to ensure no liquid enters the internal mechanism during cleaning. 5.3 Operating Procedure for Make: SARTORIUS | Model: SECURA 224-10IN 5.3.1 Ensure the cleanliness of equipment and platform; it should be clean and dry. 5.3.2 Check the spirit level; the bubble should be in the center of the circle. 5.3.3 Switch on the main power supply; the display shows “Secura”. 5.3.4 Slightly press the ON/OFF key and allow it to stabilize for 2-5 minutes. 5.3.5 When display shows “Leveling”, press the leveling icon. Ensure the bubble shows green. 5.3.6 Select the menu key on the bottom left of the weighing screen. 5.3.7 Menu Applications: 5.4 Sample Weighing 5.4.1 After calibration, press the Tare/Zero key. Wait for a stable zero reading. 5.4.2 Place the sample/container in the center of the pan. Close the draft shield window. 5.4.3 Wait for stabilization, then record the weight. Clean the balance after weighing. 5.4.4 Put the balance in standby mode when not in use. 5.5 Data Printer Operation 5.5.1 Connect the printer and switch on the power. Green light indicates readiness. 5.5.2 Press the “Print” button to generate the header (Date/Time). 5.7.1 Daily Calibration (Self-Calibration) 5.7.1.1 Perform self-calibration daily after 30 minutes of warm-up. 5.7.1.2 Select “CAL” from the menu and press “CAL-Intern”. 5.7.1.3 Verify weights: 0.1g, 1g, 10g, and 200g. Record in Annexure-01. 5.7.1.4 Acceptance Tolerance: Variation should not exceed ± 0.1% of certified value. 5.7.2 Monthly Calibration 5.7.2.1 Sensitivity: Place 200g weight. Limit: ± 0.05%. 5.7.2.2 Eccentricity: Place 100g weight in center and 4 corners. Limit: ± 0.05%. 5.7.2.3 Repeatability: 10 weighings of 200mg weight. Limit: ± 0.10% (Uncertainty). 5.7.2.4 Linearity: Test 100mg, 200mg, 500mg, 1g, 100g, 200g. Limit: ± 0.05%. 6.0 ABBREVIATIONS 8.0 ANNEXURES PHARMA MICROHUB ANNEXURE-01: ANALYTICAL BALANCE DAILY CALIBRATION RECORD SOP No:SOP/PH/002-00 Format No: FMT/PH/002-00 Effective Date: 06/04/2026 Page No: 01 of 01 DAILY CALIBRATION LOG Instrument Name/ID: ________________________ Month/Year: ________________ Date Standard Weight (g) Observed Weight (g) Deviation (%) Sign (Analyst)   0.1 g         1.0 g         10.0 g         200.0 g       Next Date: 0.1 g         1.0 g         10.0 g         200.0 g       Acceptance Criteria: For 0.1g to 200g the variation should not be more than ± 0.1% of the certified mass value. Prepared By (Analyst) Checked By (QA) PHARMA MICROHUB ANNEXURE-02: ANALYTICAL BALANCE MONTHLY CALIBRATION RECORD SOP No: SOP/PH/002-00 Format No: FMT/PH/002-00 1. SENSITIVITY (Std. Weight: 200g) Standard Weight: 200.0000g Observed Weight: __________ g Limit: ± 0.05% 2. ECCENTRICITY (Std. Weight: 100g) Position Observed (g) Deviation (%) Position Observed (g) Deviation (%) Center (1)   — Front Left (2)     Back Left (3)     Back Right (4)     Front Right (5)     Limit: ± 0.05% 3. REPEATABILITY (Std. Weight: 200mg | n=10) 1. ______ 2. ______ 3. ______ 4. ______ 5. ______ 6. ______ 7. ______ 8. ______ 9. ______ 10. ______SD: _________ | Uncertainty ($U$): _________% (Limit: ± 0.10%) 4. LINEARITY (Limit: ± 0.05%) Weight 100 mg 200 mg 500 mg 1 g 100 g Observed           Analyzed By Checked By (QA) Approved By (HOD) PHARMA MICROHUB ANNEXURE-03: CLEANING & OPERATION LOG SOP No: SOP/PH/002-00 Format No: FMT/PH/003-00 CLEANING AND OPERATION OF TOP LOAD BALANCE LOG Date Product/Material Name Batch No. / AR No. Cleaning Status (Start/End) Sign (Analyst)                                                   Note: Cleaning must be performed before and after each usage. Ensure spillage is cleaned immediately. Verified By (Supervisor/QA) Date of Review   Get ready to download editable SOPs in word document

Logging, Investigating, reporting, and disposing of Microbiology Laboratory Incidents. Pharma Micro Hub Document No: SOP/MB/XXX TOPIC: Microbiology Lab Incident Procedure Revision Date: 05-Apr-2028 Effective Date: 06-Apr-2026 Supersedes: New Page No: 1 of 3 Approved By: Head QA 1.0 Objective To lay down a procedure for Logging, Investigating, reporting, and disposing of Microbiology Laboratory Incidents. 2.0 Scope This procedure is applicable for all the laboratory incidents logged in the Microbiology Laboratory. 3.0 Responsibility 4.0 Accountability Head/Designee – Microbiology. 5.0 Procedure 5.1 General Definitions 5.1.1 Incident: An incident can be defined as an unplanned or uncontrolled event in the form of non-compliance to the designed system or procedures at any stage during receipt, storage, handling, disposal and analysis of samples due to system failure, environmental variations, procedural errors or equipment breakdown or manual error. 5.2 Incident Types 5.4 Numbering of Laboratory Investigation Report (LIR) 5.4.11Numbering Format: LIR/PM/YY/XXX The unique identification number for an LIR is constructed as follows: Example: The first LIR filed in the Microbiology department for the year 2026 would be numbered as: LIR/PM/26/001 Laboratory supervisor is responsible for assigning the number for LIR in Annexure-01. Note: In the absence of the Laboratory supervisor, the analyst can initiate the LIR. 5.5 LIR Investigation, Closing and Disposition of Incidents 6.0 Abbreviations Abbreviation Full Form LIR Laboratory Investigation Report HOD Head of the Department QA Quality Assurance SOP Standard Operating Procedure 8.0 Annexures   Get ready to download editable SOPs in word document