Standard Operating Procedure for Use of Weighing Balances for Material Dispensing
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/102/2025 |
| Supersedes | SOP/SIM/102/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To establish a uniform procedure for the proper use, calibration verification, and maintenance of weighing balances used for dispensing raw materials in sterile injectable manufacturing.
2. Scope
This SOP is applicable to all analytical and precision balances located in dispensing booths and
weighing rooms of the sterile injectable manufacturing facility.
3. Responsibilities
- Operator: Responsible for cleaning, using, and documenting weight measurements on balances.
- Production Supervisor: Ensures balances are calibrated and maintained before use.
- QA Officer: Verifies weighing operations and documentation.
- Engineering/Maintenance: Performs periodic preventive maintenance of balances.
4. Accountability
The Head – Production Department is accountable for proper implementation of this SOP.
5. Procedure
5.1 Pre-Use Checks
- Verify balance calibration status using calibration sticker and certificate.
- Check bubble level and adjust using leveling screws if needed.
- Ensure the balance is clean, vibration-free, and placed on a stable surface.
- Allow the balance to warm up for at least 30 minutes after switching on.
5.2 Daily Performance Check
- Use certified reference weights (as per Annexure-1) to verify performance.
- Record verification details in the Balance Verification Log (Annexure-2).
- If performance is out of tolerance, inform QA and service personnel immediately.
5.3 Weighing of Materials
- Use appropriate containers/tared vessels for weighing.
- Press “Tare” before weighing the material to set the balance to zero.
- Weigh the required quantity and document it in the BMR and weighing log.
- Avoid overloading; never exceed the balance’s maximum capacity.
5.4 Post-Weighing Activity
- Clean the balance surface using lint-free cloth and 70% IPA.
- Record usage in the equipment usage log.
- Switch off the balance at the end of the shift.
5.5 Precautions
- Do not use the balance if the calibration is expired.
- Avoid weighing materials with high static charges without proper grounding.
- Prevent exposure to drafts and temperature fluctuations during weighing.
6. Abbreviations
- SOP: Standard Operating Procedure
- IPA: Isopropyl Alcohol
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Standard Weight Reference Table – Annexure-1
- Daily Balance Verification Log – Annexure-2
- Balance Usage Logbook – Annexure-3
8. References
- USP Chapter 41 – Balances
- 21 CFR Part 211 – GMP for Finished Pharmaceuticals
- Internal Calibration SOP of the organization
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Standard Weight Reference Table
| Weight (g) | Tolerance (± mg) | Material |
|---|---|---|
| 1 g | 0.2 | Stainless Steel |
| 10 g | 0.3 | Stainless Steel |
| 100 g | 0.8 | Stainless Steel |
Annexure-2: Daily Balance Verification Log
| Date | Balance ID | Weight Used | Reading | Status | Checked By |
|---|---|---|---|---|---|
| 18/06/2025 | BAL-DISP-01 | 10 g | 9.998 g | Pass | Sachin Patil |
Annexure-3: Balance Usage Logbook
| Date | Time | Material | Batch No. | Qty Weighed | Operator |
|---|---|---|---|---|---|
| 18/06/2025 | 09:10 | Sodium Chloride | NC2501 | 500 g | R. Sharma |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 05/01/2022 | 1.0 | Initial release | New SOP | Head QA |
| 18/06/2025 | 2.0 | Added annexures and clarified balance setup steps | Periodic Review | Head QA |