Fundamental Skills for Laboratory Personnel Course Information

Water Testing

The principles and techniques used in testing different types of water.

Organization
Microbiological Water Testing is part of the Microbiology Skills curriculum. Course Reference Code is 5002WT.

Goal

The goal of this module is to provide basic information about Microbiological Water Testing and its importance in a pharmaceutical testing laboratory.

Pour plates Membrane filter Prepared filter assemblies Instrumental method (e.g., epifluorescence, radiometric, etc.) Incubator

Recommended Prerequisites

Analytical Weighing Sample Handling and Preparation Volumetric Technique Handling Numbers and Performing Calculations

Estimated Time to Complete this Module:

45 - 60 minutes

(Course Code Learning Objective Number) 5002WT-LO01: Identify important principles and concepts in water testing, including: High purity water Micro testing and monitoring of water systems Purified Water Apyrogenic Water for Injection (WFI) Endotoxins Enumeration Trend analysis Drinking Water (DW) Clean Steam Validation of water systems Sampling procedure Testing methods Culture media Incubation Negative-positive controls Validation of testing method Alert-action levels Identification of microbial isolates Specified microorganisms Failure investigation Training of personnel

Learning Objectives

5002WT-LO04: Describe, in general terms, the processes and activities related to water testing, including: Water samples are properly stored before analysis begins Appropriate growth media is selected, prepared, demonstrates that it supports growth Prepare negative controls Neutralizing samples containing sanitizing agents Technique to be used (classical culture, instrument, enumeration) is determined Endotoxin testing is conducted Absence of specified organism test is conducted Results are determined and compared to alert, action, spec limits Isolates are identified as required Investigation is conducted as required 5002WT-LO05: Identify the importance of water testing in the pharmaceutical industry and how it is used with respect to the safety, identity, strength, purity, and quality of products. Suggested reasons of importance include: Water is regarded as a raw material and has the potential to leave contaminants in the product Water is also used in many different cleaning processes, and, if contaminated, could affect multiple batches 5002WT-LO06: Identify the safety practices and equipment that are intended to prevent injury to laboratory personnel and damage to equipment, instruments, and facilities. Prepare Read Method Check PPE Collect Equipment Gather Media Sanitize Working Area Aseptically Assemble Filter Apparatus Perform Pour Samples through Filter Units Rinse Filters Remove and Plate Filter Incubate Sample Read Sample and Record Results

5002WT-LO02: Identify terms that are relevant to water testing, including: Drinking (potable) water (CW) Deionized water (DIW) Purified water (PW) Highly purified water (HPW) Water for Injection (WFI) Other forms of sterile water Clean steam Endotoxins 5002WT-LO03: Given accurate visual examples of equipment, materials, and tools involved with water testing, identify their name, function, and importance. Specifically this includes: Water sampling containers Clean steam sampling containers Class A Laminar air flow hood

5002WT-LO07: Given examples of techniques used when performing water testing, differentiate between acceptable (good) and unacceptable (poor) practices that involve: Worker health and safety Preparing an acceptable work area for testing water samples for microbes 5002WT-LO08: Identify the correct steps and sub-steps in the proper sequence when using or performing water testing. 5002WT-LO09: Given a question related to water testing that could be asked by a new laboratory analyst, provide an answer that is consistent with standard industry and scientific practices.

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