Water Analysis

Water Analysis

Water analysis for every grade of quality

Water plays a central role in the production of pharmaceuticals. The most stringent quality requirements apply to pharmaceutical water, both as a product component and in industrial consumption. Physico-chemical and microbiological quality control are essential for manufacturing in accordance with GMP and are prescribed by law.

As a GMP accredited and FDA registered contract laboratory in Switzerland, we can test pharmaceutical water for you in all quality grades according to current pharmacopoeia methods. With our own transport service to deal with sampling logistics, we can ensure the timely implementation of the microbiological analysis.

Would you like to know which tests you require, or would you like support in sampling? We are very happy to advise you and can provide you with the suitable vessels.

 

Read on here for more information or contact us.


Legal Provisions - European Pharmacopoeia (Ph. Eur.)

The European Pharmacopoeia has the categories:

  • Purified water (Aqua purificata) - differentiated here into “purified water in bulk” and “purified water filled into containers”.
  • Highly purified water (Aqua valde purificata)
  • Water for injection (Aqua ad iniectabilia) - differentiated here into “water for injection in bulk” and “sterilised water for injection”.

 

Additional test parameters are necessary if the water is to be used for dialysis solution.

Water analysis: The sampling point of an ultra-pure water facility
Water analysis: The sampling point of an ultra-pure water facility

An overview of the limit values and mandatory testing according to the Ph. Eur. (extract)

Parameter / Test of purified water in bulk Ph. Eur. Monograph 0008 The purified water filled into containers Ph. Eur. Monograph 0008 Highly purified water Ph. Eur. Monograph 1927 Water for injection (WFI) in bulk Ph. Eur. Monograph 0169
Overall colony-forming units

× ≤ 100 CFU / ml

× ≤ 100 CFU / ml

× ≤ 10 CFU / 100 ml

× ≤ 10 CFU / 100 ml

Total Organic Carbon (TOC)

× ≤ 0.5 mg / L

× ≤ 0.5 mg / L

× ≤ 0.5 mg / L

× ≤ 0.5 mg / L

Conductivity (COND)

× dependent on temperature, 5.4 uS/cm at 20°C, 3 stage process if necessary
(pH-value at third level)

×

× dependent on temperature, 1.3 uS/cm at 20°C, 3 stage process if necessary
(pH-value at third level)
× if necessary 3 stage process
(pH-value at third level)
Heavy metals (Ph. Eur. 2.4.8)

× ≤ 0.1 ppm

× ≤ 0.1 ppm

-

-

Heavy metals

(×) If the COND limit value for WFI has been fulfilled, then not necessary.

(×) If the COND limit value for WFI has been fulfilled, then not necessary.

(×) If the COND limit value for WFI has been fulfilled, then not necessary.

-

Nitrate

× ≤ 0.2 ppm

× ≤ 0.2 ppm

× ≤ 0.2 ppm

× ≤ 0.2 ppm

Aluminium

(×) ≤ 10 ppb only if intended for dialysis solutions

(×) ≤ 10 ppb only if intended for dialysis solutions

(×) ≤ 10 ppb only if intended for dialysis solutions

(×) ≤ 10 ppb only if intended for dialysis solutions

Bacteria- endotoxins

(×) ≤ 0.25 I.E. / ml only if intended for dialysis solutions

(×) ≤ 0.25 I.E. / ml only if intended for dialysis solutions

(×) ≤ 0.25 I.E. / ml only if intended for dialysis solutions

(×) ≤ 0.25 I.E. / ml only if intended for dialysis solutions

Acidic or alkaline reacting substances

×

×

-

Oxidisable substances

-

×

-

-

Chloride

-

×

-

-

Sulphate

-

×

-

×

Ammonium

-

×

-

-

Calcium, Magnesium

-

×

-

-

Evaporation residue

-

× ≤ 0.001 %

-

-

Microbial impurity (TAMC)

-

Acceptance criterion
102 CFU / ml

-

-

Harmonised methods in the USP and the Ph. Eur.

The USP regulates the limit values for pharmaceutical water in the same manner as the Ph. Eur. The corresponding monographs are completely harmonised.

Sample vessels

Sample vessels for TOC analysis
Sample vessels for TOC analysis

It is essential to choose suitable sample vessels to avoid contamination of the samples as a result of substances being liberated from the walls of the vessel - and hence to reduce the danger of possible “false positives”. Borosilicate glass or high-quality plastics have proved to be the best.

We would be pleased to provide you with sample vessels at no cost for the TOC testing. These will ensure the steady and stable high quality of your test results. Using the incorrect sample vessels can easily lead to contamination affecting the OOS findings.

Sampling for TOC determination

You can find a detailed set of instructions on sampling for TOC in our download area.

Sample transport/time

We recommend beginning the microbiological tests on the day that the sampling is done. As a result, it is essential that your samples are with us by 3pm. It is important that the samples are sent to us in a non-refrigerated state - otherwise a range of bacteria would be partially killed off and the results would be falsified.


Our services in detail:

Microbiological testing of water for pharmaceutical purposes
Microbiological testing of water for pharmaceutical purposes

contact person

sales pharmaceuticals

Michael Trösch Graduate Chemist HTL

Tel. +41 58 434 42 00 Fax +41 58 434 42 01 service@ufag-laboratorien.ch

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