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Questions and Answers

What is the purpose of this SOP?

To analyze the raw and purified water used in the company according to the methods of analysis and specifications set for this purpose.

What does the abbreviation "MDI" stand for?

Modern Company for Drugs Industries

Which of the following tests are performed daily for purified water?

Turbidity (correct)

Odor (correct)

Conductivity (correct)

TOC

Iron

Color (correct)

Total chlorine (correct)

Appearance (correct)

PH (correct)

Calcium hardness

Ammonia

Sulfate

TDS (correct)

Magnesium hardness

Which of the following tests are performed weekly for purified water used for washing purposes?

TDS Signup and view all the answers

What is the minimum pH requirement for purified water?

5.0 Signup and view all the answers

What is the maximum turbidity level allowed for purified water?

5 NTU Signup and view all the answers

What is the maximum sulfate level allowed for purified water?

1.00 mg/l Signup and view all the answers

What is the maximum calcium hardness level allowed for purified water?

1.00 mg/l Signup and view all the answers

What is the maximum iron level allowed for purified water?

0.5 mg/l Signup and view all the answers

What are the total dissolved solids (TDS) limits for purified water?

10.00 mg/l Signup and view all the answers

What is the maximum total organic carbon (TOC) allowed for purified water?

500 ppb Signup and view all the answers

What is the pH range for raw water?

6.5 - 8.5 Signup and view all the answers

What is the maximum turbidity level allowed for raw water?

5 NTU Signup and view all the answers

What is the maximum sulfate level allowed for raw water?

400 mg/l Signup and view all the answers

What is the maximum calcium hardness level allowed for raw water?

150 mg/l Signup and view all the answers

What is the maximum iron level allowed for raw water?

0.3 mg/l Signup and view all the answers

What is the maximum total dissolved solids (TDS) allowed for raw water?

1000 mg/l Signup and view all the answers

This SOP applies for raw and purified water testing in the ______ production building.

normal Signup and view all the answers

The sixth version of this SOP includes a logbook format.

True Signup and view all the answers

Which of the following is NOT a test performed on purified water?

Total Organic Carbon Signup and view all the answers

The instrument directly displays concentration in mg/l of ______ on the liquid.

sulfate Signup and view all the answers

Study Notes

Standard Operating Procedure (SOP) for Water Analysis

Title: Specifications and Chemical, Physical Analysis Methods for Raw and Purified Water in Normal Production
SOP Number: QC-008E
Effective Date: 30/08/2022
Document Revision: Every 3 years or as needed
Company: Modern Company For Drugs Industries (MDI)

History: Page 2
Purpose: To analyze raw and purified water according to analysis methods and specifications
Scope: Applies to raw and purified water testing in normal production
References: MDI's internal SOPs
Abbreviations and Definitions: Lists various abbreviations used in the SOP (e.g., SOP, MDI, QA, QC, µs, NTU, mg/l, Max, Ref)
Procedure: Page 3, detailed steps for chemical and physical analysis of raw and purified water
Responsibility: Outlines responsibilities of different personnel (Quality Control Analyst, Quality Control Manager, Engineering Manager, and Quality Assurance Manager) involved in water testing and quality control
Documents Revision: Page 9, lists the different revisions of the document and the dates

Procedure Details (Partial)

Sample Preparation: Collect samples from various sections; allow water to drain for 2 minutes for purified water; Collect samples from raw water sources.; Rinse bottles with sample water three times before filling
Testing Methods (Examples): Daily tests for purified water include appearance, odor, color, pH, conductivity, TDS, turbidity, and total chlorine. Weekly tests include ammonia, iron, calcium hardness, magnesium hardness, sulfate, and TOC
Instrument Calibration: Calibration is required for pH, turbidity, and sulfate tests using standard solutions.
Results: Results are documented in logbooks (Appendix-1 and Appendix-2)
Frequency: Raw water testing is monthly; Purified water testing differs according to usage and purpose (daily, weekly).

Water Specifications (Examples)

Purified Water: Colorless, odorless, clean liquid
Raw Water: Specifies parameters like color, odor, taste, turbidity, pH, conductivity, sulfate, ammonia, total chlorine, calcium hardness, magnesium hardness, iron, total dissolved solids, and total organic carbon
Values Provided: Maximum permissible values for each respective parameter are given for both raw and purified water

Appendices

Appendix-1: Detailed logbook for purified water tests
Appendix-2: Detailed logbook for raw water tests
Appendix-3: Follow-up program for the purified water station for different tests involved

Responsibility

Quality Control Analyst (QC Analyst): Performs analysis
Quality Control Manager (QC Manager): Reviews reports before release to production
Production: Does not start production without analysis of purified water
Quality Assurance Manager (QA Manager): Provides oversight and follow-up