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TARGETS

To control the sources of contamination

To comply with the levels of total viable bacteria and to obtain a water quality that complies with European Pharmacopoeia standards

To improve the quality and safety of medicines to protect public health

Protect your equipment and water loops from bacterial contamination

PROTECT YOUR WATER LOOPS AND PRODUCTION EQUIPMENT

Thanks to our rigorous approach including techniques and tools specifically designed to deal with the biofilm problem. Only total control can guarantee compliant and sustainable hygiene.

Have you ever experienced problems with your production equipment or water networks? Or do you want to prevent these risks?

Some bacteria such as Ralstonia picketi can proliferate and impact the expected quality of your water (PW, WFI) and your finished product.

EUROPEAN PHARMACOPOEIA EXTRACT 7.0

La Pharmacopée Européenne impose The European Pharmacopoeia lists the following specifications for total viable germs:

  • PW: ≤ 100 CFU / ml
  • WFI: ≤ 10 CFU / 100 ml

A loss of control can have serious consequences that can alter the quality of the medicine as well as its safety, which could affect public health. A production shut-down would also have dramatic consequences for any manufacturer.

It is therefore essential to control the risks of contamination, which means knowing how to detect them.

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treatment

BiLiSS®

For the treatment of bacterial contamination, BiLiSS® ensures the elimination and prevention of biofilm development.

  • Patented multi-enzymatic solution
  • PDE
  • Residue-free validation method

TYPE OF ANALYSIS

  • Quantification of active bacteria
  • Qualification of biofilm-forming bacteria
  • Accurate total bacterial count
  • Characterisation of the flora
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Realzyme LLC, 219 S Pioneer Blvd, Suite, Springboro OH 45066