control

Moni­to­ring

Micro­bial cont­a­m­i­na­tion moni­toring

Hete­ro­tro­phic Plate Count (HPC) is the only compen­dial method for micro­bial cont­a­m­i­na­tion moni­toring today. A serious concern for imple­menting a CCS as described in Annex I, is the fact that HPC does not detect all microor­gan­isms in a sample and the time to the result is very long. Only colony forming units (CFU) are detected. Studies have shown that the number of CFU does not reflect the number of microor­gan­isms in a system. To grasp the real micro­bial situ­a­tion in a water purifi­ca­tion system, rapid methods should be consid­ered to gain more control.

Learn about why HPC Analysis results in a perma­nent under­es­ti­ma­tion of the bioburden and how you gain more control over the bioburden mani­fes­ta­tion of your water purifi­ca­tion system by using Rapid Micro­bial Methods (RMM). The EU GMP Annex 1 encour­ages the use of RMM as well.

Annex I mentions in Chapter 2.3 that “a Cont­a­m­ination Control Stra­tegy must be imple­mented across the faci­lity in order to define all Crit­ical Control Points.” This can also be broken down to the water purifi­ca­tion process. Manual sampling and HPC analysis inter­vals are defined throu­ghout the PQ phase. Typical sampling inter­vals are: Daily… Weekly… Monthly. In process control is not regu­lated. But Annex I and other regu­la­tions...

Limi­ta­tions of HPC

Why does hpc not show the real bioburden?

Because only colony forming bacteria can be detected.

The popu­la­tion of microor­gan­isms in a water purifi­ca­tion system is very versa­tile. Microor­gan­isms may exist in diffe­rent envi­ron­ments and phases of their life cycle.


The popu­la­tion consists of:

  1. Free floa­ting indi­vidual organ­isms
  2. Organ­isms that are atta­ched to parti­cles
  3. Organ­isms that are atta­ched to any surface (Biofilm)
  4. Frag­ments of biofilm freely floa­ting in the water

Under­stan­ding conglo­me­rates and VBNC Microbes

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moni­toring: new methods

Due to the limi­ta­tions of HPC and the increa­sing demands in micro­bial process control, diffe­rent tech­nolo­gies for RMM (Rapid Micro­bi­o­log­ical Methods) are under inves­ti­ga­tion. Various suppliers and several phar­ma­ceu­tical compa­nies are looking for solu­tions to receive more infor­ma­tion about the bioburden in phar­ma­ceu­tical water. With the publi­ca­tion of the EU GMP Annex I, it is obvious that also regu­la­tory autho­ri­ties are inte­re­sted in new methods that elimi­nate sampling error, improve process control and produce reliable data in shorter inter­vals.

As stated in the EU GMP Annex I: "...The adop­tion of suit­able alter­na­tive moni­toring systems such as rapid methods should be consid­ered by manu­fac­turers in order to expe­dite the detec­tion of micro­bi­o­log­ical cont­a­m­i­na­tion issues and to reduce the risk to product. These rapid and auto­mated micro­bial moni­toring methods may be adopted after vali­da­tion has demon­strated their equiv­a­lency or supe­ri­ority to the estab­lished methods..."
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medicines agency logo

HOW THE USE OF RMM BENE­FITS YOUR CCS

  • Full insight of the current state of bioburden in the phar­ma­ceu­tical water system
  • Trend moni­to­ring allows for targeted plan­ning of sani­ti­za­tion and main­te­nance works, due to their neces­sity (which also protects the heat and chemical sensi­tive mate­rials)
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Flow­cy­to­metry  the best RMM for phar­ma­ceu­tical water systems
Preview Product Video ASMB
Preview Product Video ASMB

Want to know more?

Learn more about Cont­a­m­i­na­tion Control Stra­tegy and the 4 elements of it...

Consu­lenza

Stati Uniti

Sedi responsabili BWT

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