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Manual 042 Sample

This document provides standards and procedures for water quality testing. It outlines sampling procedures and minimum frequencies. It specifies appropriate test methods and specifications for different types of water, including potable water, purified water, and high purity water. It also addresses storage, distribution, and the appropriate grade of water for different applications like sterilization and humidification.

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Mostafa Fawzy
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48 views

Manual 042 Sample

This document provides standards and procedures for water quality testing. It outlines sampling procedures and minimum frequencies. It specifies appropriate test methods and specifications for different types of water, including potable water, purified water, and high purity water. It also addresses storage, distribution, and the appropriate grade of water for different applications like sterilization and humidification.

Uploaded by

Mostafa Fawzy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Title: Water Quality Standard

Manual Number: 042


Prepared by: Date: Supersedes:
Checked by: Date: Date Issued:
Approved by: Date: Review Date:

Manual: 042

Water Quality Standard

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‡ Location of sampling points
‡ Quantity of sample required
‡ Sampling instructions
‡ Sample storage including any time limitations to perform the analysis
‡ Training of samplers

Samples should be collected from points of use in the same way as, or in a
manner that simulates how the water is used during routine production.
Where possible samples will be taken on a rotational basis to ensure that points
are not always sampled on the same day.

Samples that are not taken from points of use, and which may be taken from a
sample point that is exposed to the elements, may be flushed for a defined time to
ensure the sample reflects the water in the system.
See Appendix 1 for suggested minimum sampling frequencies.

5.2 Testing

Written, approved and validated test methods are required. Test methods as per the EP
or United States Pharmacopeia (USP) are considered validated.

5.2.1 Potable Water

Testing for the full analytical requirements for Potable Water is usually outside
the scope of the typical pharmaceutical laboratory. The recommended practice is
to receive Analytical Reports and/or Certificates of Analysis from the
municipality/supply company providing the water, together with supporting local
test data.

If alternative sources of water are used, e.g. borehole/well water, it may be


possible to arrange for the local municipality/supply company or a contract water-
testing laboratory to sample and test the water against the appropriate standard.

The local site should perform a limited number of analytical monitoring tests that
have been pre-established in a local procedure or standard.

5.2.2 Purified Water

The tests, methodology and specifications for Purified Water are described in the
relevant Pharmacopoeias.

5.2.3 Endotoxin-Controlled Purified Water

The tests, methodology and specifications for Endotoxin-Controlled Purified


Water are, as minimum, the same as for Purified Water with the addition of the
Bacterial Endotoxin Test with a limit of not more than 0.25 IU/ml.

5.2.4 HPW

The tests, methodology and specifications for HPW are described in the EP.

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5.4.3 Endotoxin-Controlled Purified Water

Analytical testing frequency would be as for Purified Water.

5.4.4 HPW

Analytical testing of a HPW system would typically be performed weekly. As


with Purified Water and WFI systems it is now common to install in-line meters
to perform TOC and Conductivity measurements.

5.4.5 WFI

Analytical testing of a WFI system would typically be performed weekly. As with


Purified Water systems it is now common to install in-line meters to perform
TOC and Conductivity measurements.

5.4.6 Pure Steam

Analytical testing of Pure Steam condensate would typically be performed


monthly.

5.5 Storage and Distribution

Particular care is required for the storage and distribution of water. The major
concern is maintaining the microbiological quality of the water. Typically enough
Potable Water is held in a buffer or break tank to provide a uniform flow and
working pressure for the user point(s) and/or treatment system. Should it be
necessary to hold larger quantities of Potable Water then an anti-microbial pre-
treatment step is likely to be required. Depending on the quantity being held
various options include the use of UV light, ozone addition or chlorination,
although any chemical added must not exceed the Potable Water quality
standards.

Any chemicals added during pre-treatment or subsequent conversion to


Purified Water or other higher quality waters must be removed as part of
the purification process

Purified Water and Endotoxin-Controlled Purified Water is usually held and


distributed in stainless steel vessels and pipes although plastic alternatives have
been successfully used. It is typical to make use of hygienic designs, provide re-
circulating distribution systems and to provide for routine sanitization to maintain
the quality of stored Purified Water. It is possible to add ozone to the storage tank
and to remove the ozone with UV light during distribution. Periodically turning
off the UV light and letting the ozonated water circulate for an appropriate time
will sanities the distribution system. An alternative method with stainless steel
systems is to periodically heat the Purified Water to about 80 ºC and circulate the
heated water through the distribution system for an appropriate time before
cooling back to ambient temperature.

Steam sanitisation of systems with Pure Steam may be possible although this
would normally only be used in the event of, for example, major microbiological
contamination or major modifications to, e.g. WFI systems.

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HPW & WFI

Class 1: at least one point each day with each point of use tested at least weekly.

Class 2: monthly

Class 3: exception basis only, e.g. investigating results Out of Specification


(OOS) and/or exceeding the Action Limit.

PURE STEAM (CONDENSATE)

Class 1: at least one point, plus the supply from the Pure Steam Generator
(PSG) is tested monthly.

Class 2: quarterly.

Class3: exception basis only, e.g. investigating results Out of Specification


(OOS) and/or exceeding the Action Limit.

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(*) Use same grade of water as used in manufacturing process if higher.

(**) If a subsequent depyrogenisation step is used, HPW may be used subject to


appropriate justification and validation

The final rinse of non-contact parts of, for example, packing lines, may be done with
Potable Water unless there are technical requirements for greater purity.

Appendix 2 (Cont¶d)

For Sterilization, Humidification and Energy Transfer:

Filtered
Utility*
Pure Steam Utility*
Application Steam
Steam

Sterilisation ± product and/or contact parts


X
compromised by corrosion inhibitors and/or
pyrogens
Sterilisation ± product and/or contact parts not
X
compromised by corrosion inhibitors and/or
pyrogens
Humidification ± product and/or contact parts
X
exposed to air and compromised by corrosion
inhibitors and/or pyrogens
Humidification ± product and/or contact parts
X
exposed to air and not compromised by
corrosion inhibitors and/or pyrogens
Humidification ± product and/or contact parts X
not exposed to air
Energy Transfer ± product and/or contact
X
parts in contact with steam and compromised
by corrosion inhibitors and/or pyrogens
Energy Transfer ± product and/or contact
parts in contact with steam and not X
compromised by corrosion inhibitors and/or
pyrogens
Energy Transfer ± product and/or contact X
parts not in contact with steam

Note:
*
Utility Steam is steam produced in conventional plant utility boilers.

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