Document: BHHRL/001PR028
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Standard Operating Procedure
Version: 1.0
Tel: +267 3902671;
Fax: +267 3901284
Water Quality Testing
Non-Smile Resource
Document Number:
Fac30-01
Effective (or Post) Date:
18 Jul 08
Document Origin: BHHRL
Company:
BHHRL
SMILE Approved by:
Jo Shim
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are directed to counter check facts when
considering their use in other applications. If you have any questions contact SMILE.
Water Quality Testing
Title:
Author:
Name, Title
Signature, Date
Prepared By:
Chishamiso Mudenyanga, Lab Research Assistant
Approved By:
Name, Title
Dr. Rosemary Musonda, Laboratory Director
Review Date
Revision Date
Signature, Date
Signature, Date
Annual Review
Location:
Distributed To:
Master file
Director –
Dr. Musonda
Director –
Dr. Mine
Lab Managers –
Mr. S. Moyo
Mrs. K. Makhaola
Lab Coordinator
Copy Number: _________
Copy
Number:
1
2
Location:
Copy Number
3
4
5
6
___________________________________________________________________________________________
Effective Date: 01/06/2008
Page 1 of 7
Confidential Controlled Document
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Document: BHHRL/005PR01
Standard Operating Procedure
Water Quality Testing
Version: 1
Tel: +267 3902671;
Fax: +267 3901284
1.0 General Policy
1.1 The laboratory has processes and procedures to effectively ensure that all water used in the laboratory
meets the correct standards for laboratory testing. It thus must determine how often to measure the
parameters of its purified water and purification system.
2.0 Purpose
2.1 This policy provides direction for the processes and procedures to effectively ensure that all water used
in the laboratory meets the correct required standards.
2.2 This is based upon requirements for specific tests, procedures, instrumentations or laboratory. The
laboratory should have an adequate supply of needed water.
3.0 Scope
3.1 These processes and procedures apply to all the water that is used in the BHHRL.
4.0 Responsibilities
4.1 The BHHRL Laboratory Manager is responsible for:
4.1.1
Ensuring that the laboratory is equipped with required water purification system that, at a
minimum cost, meets the specifications of the purifying system.
4.2 The Quality Assurance Officer is responsible for:
4.2.1
Ensure that equipment maintenance and calibration are conducted.
4.2.2
Providing support for arranging non-routine system repair and reordering of replacement
parts.
4.2.3
In cases where the water can not be processed in the laboratory, reliable suppliers of the
required water must be established.
4.2.4
Maintaining the equipment maintenance records.
4.2.5
Ensuring that specifications for laboratory use are checked.
4.2.6
Proper labeling of stored water.
4.2.7
Logging in water supplied by suppliers.
4.3 The Staff is responsible for:
4.3.1
Proper storage of water.
4.3.1.1 Adhering to written equipment operation procedures including preventive
maintenance and calibration procedures, and
4.3.1.2 Verifying that equipment conforms to specifications prior to use and completing
the documentation of such verification.
5.0 Materials
5.1 Restivity/ conductivity meter
5.2 pH meter
5.3 Clean container to hold 50ml of water
5.4 pH standards and containers
6.0 Procedures
6.1 Background Information: The unique ability of water to dissolve, to some extent, virtually every
chemical compound and support practically every form of life means that raw water supplies contain
many contaminants. The major categories of impurities found in raw water include:

Suspended particles, including colloids
____________________________________________________________________________________________________
Effective Date: 01/06/2008
Page 2 of 7
Confidential Controlled Document
Document: BHHRL/005PR01
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Standard Operating Procedure
Water Quality Testing
Version: 1
Tel: +267 3902671;
Fax: +267 3901284





6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
6.1.6
Dissolved inorganic salts
Dissolved organic compounds
Micro-organisms
Pyrogens
Dissolved gases
Clinical Laboratory Reagent Water (CLRW):- should be pure enough to satisfy the
requirements of most routine clinical laboratory testing. This type of water is usually
used for the reconstitution of controls and reagents and with instruments using water for
analysis. The requirement for microbial content, resistivity, Total Organic Content (TOC)
and particulate matter are the same as Type I
Special Reagent Water (SRW):- is used in testing that requires different purity other
than CLRW. This could include different levels of CO 2, trace metals, or organic
impurities.
Instrument Feed Water: - is intended for internal rinsing, dilution and water bath
functions of automated instruments. The specification of this type of water must be
confirmed with the manufacturer of a specific instrument.
Water Supplied by a method manufacturer for use as a diluent or reagent: - This
type of water must only be used as described by the product labeling for that system.
This type of water can not be used for CLRW or SRW unless it meets those specific
requirements.
Commercially bottled, purified water must meet the required specifications for its
intended use. The water should be packaged in a manner that protects it from
environmental contamination or degradation during transportation and storage, and from
the effects of the container itself. Note that any bottled water, no matter what type must
include a lot number and expiration date as well as the values for resistivity, microbial
count, TOC and information on particulate control in addition to any other applicable
parameters. Commercially bottled purified water may have met the specification for
CLRW when bottled, but at use, the bottled water should be considered SRW with
specifications set by the laboratory based on intended use. The laboratory must validate
that the bottled water is fit for its intended purpose in clinical laboratory testing. If a
bottle is opened and reused over a period of time, the laboratory must validate the water
remaining in the bottle as fit for purpose throughout the entire period of use. Each new
lot of bottled water must be validated for acceptable performance in the test procedures
for which it will be used. Validations must include chemical, microbial and particulate
quality requirements of purified water. Once validated, the acceptability of purified
water should be monitored to ensure it continues to be fit for its intended purpose
Autoclave and wash water application water is intended for use as feed water for
autoclaves and for automatic laboratory dishwashers with heat drying cycles. It is
purified to low level of inorganic, organic and particulate impurities that otherwise could
contaminate solutions and media in an autoclave or remain on washed laboratory ware.
This was previously referred to as Type III water. There is no consensus to specification
of this type of water.
6.2 Definition of water is listed below:
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Effective Date: 01/06/2008
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Confidential Controlled Document
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Reference
Laboratory
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Document: BHHRL/005PR01
Standard Operating Procedure
Version: 1
Water Quality Testing
Tel: +267 3902671;
Fax: +267 3901284
Maximum microbial content
(CFU/mL)
Minimum resistivity (megohmcm)MΩ-cm
Maximum silicate content (mg/L
SiO2)*(TOC)
Particulate matter
Type I
≤10
Type II
≤1000
Type III
n/a
≥10 (in-line)
≥1.0
≥0.1
≤0.05
≤0.1
≤1.0
≤0.22 um filter
n/a
n/a
6.3 Minimum monitoring requirement includes periodical testing of resistivity and microbiology cultures.
The frequency should be enough and the results trended to detect changes and anticipate maintenance
problems. In the new water listing Type I and II are the same as CLRW depending on the content
requirement and Type III is similar to autoclave and wash water applications.
6.4 Resistivity is an indicator of ionic contamination. It is inversely related to ionic content. The higher
this value the better the water quality. It is usually reported in megohm-centimeters (MΩ-cm).
6.5 Water Purification using the RIOs and Elix Water Purification Systems.
6.5.1
Install the reservoir. (Refer to the Polyethylene Reservoir User Manual). Note: The
reservoir is usually installed and this procedure may not always apply.
6.5.2
Operation procedures for the reservoir and RIOs system (Refer to the User Manual for
the Reservoir and RIOs and Elix water purification systems.).
6.5.3
Always keep the collection containers closed when storing water.
6.6 Check that all containers with water outsourced from external suppliers are tightly closed and the water
has no suspended particles in it before signing for it.
7.0 Quality Control
7.1 Maintenance of the reservoir
7.1.1
Check overflow tubing for any water weekly.
7.1.2
Replace vent filter twice a year
7.1.3
Sanitize overflow tubing with 5% bleach each time the vent filter is changed.
7.1.4
Replace overflow tubing if it becomes discolored.
7.1.5
Drain reservoir if not in use for over a week and make sure that the inner wall is dry
during storage.
7.2 Maintenance and Calibration of RIOs water purification system
7.2.1
Daily Maintenance – check and confirm if the instrument is in good working order.
7.2.2
Monthly Maintenance – note the operating parameters as indicated in the form in
appendix 1.
7.2.3
Bi-annually maintenance – clean screen filter and change vent filters.
7.2.4
Periodic maintenance- follow display of message on system. Refer t page 25-26 of the
operating and maintenance manual for directions on addressing the messages.
7.2.5
For detailed maintenance procedures refer to the Operating and Maintenance Manual
pages 23 to 33.
7.3 Restivity and conductivity measurement daily when water is purified.
7.3.1
Turn the restivity meter on and allow it to warm up for 5 minutes before use.
7.3.2
Obtain 50ml of water to be tested in a clean container.
____________________________________________________________________________________________________
Effective Date: 01/06/2008
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Confidential Controlled Document
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Document: BHHRL/005PR01
Standard Operating Procedure
Water Quality Testing
Version: 1
Tel: +267 3902671;
Fax: +267 3901284
7.3.3
Allow water to reach temperature of 25°C.
7.3.4
Place restivity probe in the water up to the testing line.
7.3.5
Record the reading in the log and repeat 4 more times.
7.4 pH measurement daily when water is purified
7.4.1
Use 50ml aliquot of water used to determine restivity
7.4.2
Turn pH meter on and allow it to warm for 5 minutes before use
7.4.3
Allow water to reach temperature of 25°C.
7.4.4
Place pH probe in the water up to the testing line.
7.4.5
Record the reading in the log and repeat 4 more times.
7.4.6
Discard water.
7.5 Measurement of microbial content monthly when water is purified
7.5.1
Collect water samples and sent them to the Microbiology laboratory for culture.
7.5.2
Record the results in the log sheet.
7.6 Expected values
7.6.1
The various water types used in the laboratory should have the following readings;
7.6.1.1 Glassware cleaning
 Restivity: ≥1.5
 pH: 6.5 – 7.5
 Microbial content: N/A
7.6.1.2 Laboratory analyzers
 Restivity: ≥ 10.5
 pH: 6.7 – 7.3
 Microbial content: ≤ 7 CFU/ml
8.0 Co-applicable Documents
8.1 Operating and Maintenance Manual for RiOs and Elix water purification systems
8.2 Polyethylene Reservoir User Manual
8.3 Log Sheets
8.4 Package Inserts
9.0 Appendices
9.1 Appendix 1 - Water Quality System Maintenance Form
9.2 Appendix 2 - Water Quality Testing Log sheet
10.0 References
10.1 Water Quality – Guidelines. SMILE, John Hopkins University, Baltimore, USA
10.2 Pure Water Solutions. www.millipore.com/bioscience
10.3 Operating and Maintenance manual for RiOstm and Elix(R) Water Purification systems. Millipore.
____________________________________________________________________________________________________
Effective Date: 01/06/2008
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Confidential Controlled Document
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Document: BHHRL/005PR01
Standard Operating Procedure
Version: 1
Water Quality Testing
Tel: +267 3902671;
Fax: +267 3901284
Appendix 1
Month: ………………….
Year: ………………
Monthly Maintenance
Pressure regulator
adjustment
RO Pressure
Feed water conductivity
RO permeate
conductivity
Water Temperature
RO rejection (%)
RO reject flow rate
RO Permeate flow rate
EDI concentrate flow
rate
EDI product flow rate
EDI product resistively
Clean instument
Monthly maintenance performed by: ………………………………. Date: …………...
Bi- Annual Maintenance
Clean Screen filter.
Last Cleaned:…………………………………… By:…………………………
Due date for filter cleaning: ……………………….
Screen filter cleaned by: …………………….. Date: ……………………
Periodic maintenance
Follow display of message on the water purification system and refer to Operating and Maintenance manual for the
procedure on how to carry out the displayed maintenance requirement.
Type of maintenance
Date
1. Cleaning of reverse osmosis cartridges(s)
2. Replacement of progard pretreatment pack
3. Replace vent filter
4. Check overflow tubing
5. Drain reservoir
6.
7.
____________________________________________________________________________________________________
Effective Date: 01/06/2008
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Confidential Controlled Document
Botswana-Harvard HIV
Reference
Laboratory
(BHHRL)
Document: BHHRL/005PR01
Standard Operating Procedure
Version: 1
Water Quality Testing
Tel: +267 3902671;
Fax: +267 3901284
Appendix 2
Day
Year …………………….
pH
Conductivity
(Range 6.7(Range ≥ 10.5)
7.3)
Month …………………………
Microbial Content
QC Passed
Comments
(Range ≤ 7.0 CFU/ml)
Initials
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Comments:……………………………………………………………………………………………………………
……………………………………………………………………
Reviewed by: …………………………….
Date: ………………
____________________________________________________________________________________________________
Effective Date: 01/06/2008
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