SOP for Chemical Analysis of Water Used in Manufacturing
1.0 Objective
To establish a standardized procedure for the chemical analysis of water used in manufacturing to ensure compliance with approved specifications.
2.0 Scope
This SOP is applicable to the Quality Control Laboratory for performing chemical analysis of water samples used in manufacturing processes.
3.0 Responsibility
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QC Chemist and above shall be responsible for performing the analysis.
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QC Executive shall be responsible for sample allocation and review of analytical records.
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Microbiology Chemist shall be responsible for sampling and submission of samples for chemical analysis.
4.0 Accountability
Head – Quality Control shall be accountable for the implementation and compliance of this SOP.
5.0 Procedure
5.1 Sampling
5.1.1 Water sampling shall be carried out as per the approved monthly sampling plan prepared by the Microbiologist in accordance with the respective SOP.
5.1.2 The Microbiology Chemist shall hand over the collected water samples to the Chemical Laboratory for analysis.
5.2 Sample Allocation
5.2.1 The QC Executive shall assign the received samples to the QC Chemist for analysis and record the details.
5.3 Analysis
5.3.1 The QC Chemist shall analyze the samples as per the approved water specifications and standard test procedures.
5.3.2 All observations, calculations, and results shall be recorded in the approved worksheet for water (chemical analysis).
5.3.3 All instruments used shall be calibrated and their respective Instrument ID numbers shall be recorded in the worksheet wherever applicable.
5.4 Review and Documentation
5.4.1 The QC Executive shall review the completed worksheet for accuracy and compliance.
5.4.2 The Certificate of Analysis (COA) for water samples shall be prepared as and when required by QA.
6.0 Annexure
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Worksheet for Water (Chemical Analysis)
Annexure: Worksheet for Water (Chemical Analysis)
Sampling Point: ____________________
Location: ____________________
Date of Sampling: ____________________
GTP/STP No.: ____________________
Date of Completion: ____________________
A.R. No.: ____________________
1. Description
Specification: Clear, colorless, odorless liquid
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
2. pH (at 25°C)
Limit: 5.0–7.0 / 5.0–8.0
Instrument ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
3. Conductivity (at 25°C)
Limit: NMT 1.3 µS/cm at 25°C
Instrument ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
4. Ammonium
Limit: Test solution should not be more intensely coloured than the standard solution
Test Solution ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
5. Calcium & Magnesium
Limit: A pure blue colour should be produced
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
6. Chloride
Limit: No change in appearance after 15 minutes
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
7. Sulphate
Limit: No change in appearance after at least 1 hour
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
8. Oxidisable Substances
Limit: Solution should remain faintly pink
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
9. Total Organic Carbon (TOC)
Limit: NMT 500 ppb
Instrument ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
10. Carbon Dioxide
Limit: Solution should remain clear
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
11. Total Dissolved Solids / Residue on Evaporation
Limit: NMT 0.001%
Instrument ID No.: ___________
Weight of empty beaker (W1): ___________
Weight of beaker + residue (W2): ___________
Calculation:
Total Dissolved Solids = (W2 − W1) × 10² / 100
Result: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
12. Hardness (as CaCO₃)
Instrument ID No.: ___________
Molarity of Disodium Edetate (M): ___________
Volume of Disodium Edetate consumed (V): ___________
Calculation:
Total Hardness = (V × M × 1.001 × 10⁶) / (100 × 0.01 × 1000)
Result: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
13. Heavy Metals
Limit: NMT 0.1 ppm
Test Solution ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
14. Nitrates
Limit: NMT 0.2 ppm
Test Solution ID No.: ___________
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
15. Acidity or Alkalinity
Limit: Solution should neither turn red nor blue
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________
16. Free Chlorine
Limit: NMT 0.8 ppm
Observation: ____________________
☐ Confirm ☐ Does Not Confirm
Analyzed By/Date: ___________ Checked By/Date: ___________