ColiMinder – Elevating Ultrapure Water Monitoring to Unprecedented Levels

Ultrapure water is a critical component in various industries, including pharmaceuticals and semiconductors, where the highest standards of water purity are essential. In these demanding sectors, the quality and integrity of ultrapure water are paramount. For example, typically in drinking water up to 100 CFU/ml is permitted while the limit in the semiconductor area is 1 CFU/100ml. Regulations underline the importance of pure water for pharmaceutical uses, such as obliging all sterile producing companies to examine the quality of water for injections (WFI) in batches for compliance with the limit value of 10 CFU/100ml.

ColiMinder detects of all living organisms such as:

  • Bacteria
  • Moulds / Yeasts
  • Algae / Biofilm
  • E. coli – specific
  • Enterococci – specific

The ColiMinder’s advanced on-line technology offers a breakthrough solution for continuous, and automated, monitoring of the quality of ultrapure water. By detecting even trace amounts of microorganisms the ColiMinder provides an added layer of assurance, safeguarding the integrity of ultrapure water used in critical applications. By acting swiftly contamination can be prevented from affecting critical industrial processes, preserving product integrity, and reducing operational disruptions. Additionally online measuring devices such as the ColiMinder can provide reliable support to plant operators and greatly reduce manual analysis.

Customer Benefits

  • Higher product safety offers protection against complaints due to ineffective or even harmful products
  • Reduction of the time required from manual analyses
  • Supports meeting the requirements of Annex 1
  • Cost-optimized operation of ozone and filtration systems
  • Optimized number of sanitizations
  • Enzymatic activity is unambiguous and works according to the lock and key principle
  • Only the enzymes of fundamentally viable microorganisms are recorded, regardless of their cultivability or vitality status
  • Particles or dead bacteria have no influence on the measurement result – false positive results are therefore not possible
  • The high sample volume of >5ml has a positive effect on sensitivity and precision
  • The entire measurement process is free of toxic chemicals
  • The system can be validated and can monitor itself
  • The measuring device can be fully serviced and validated by the end-user
  • The device works completely independently and fully automatically – it is sufficient to refill the consumables every 1,000 measurements
Ultrapure Water Monitoring

ColiMinder deployed for reliable online and rapid microbial monitoring in the pharma industry, to assist the customer in fulfilling the requirements of EU GMP Annex 1.

The ColiMinder Technology
The measurement principle of this fast and fully automatic method is based on an enzyme assay, a scientifically recognised method in which the enzymatic activity of the organisms present in the sample is measured. Living organisms – bacteria, but also all other micro-organisms such as algae and fungi – need enzymes for their metabolism – so ColiMinder uses the enzyme activity of the target organisms as a measure of microbiological load. There are enzymes that are specific to certain organisms or groups of organisms. This offers the possibility to specifically measure the metabolic activity of the respective target organisms.

Despite the short measurement time of 15 minutes, the detection limit of this enzyme-based method lies in the range of the usual culture- based methods, in many applications even significantly below. The low limit values for ultrapure water are taken into account by the particularly large sample volume and the high concentration of the reagents. The enzyme activity is unaffected by particles in the medium and only detects the metabolism of viable microorganisms. Any inherent fluorescence of the medium will have no effect on the measurement result. This makes the ColiMinder the most sensitive online measuring device for recording microbiological loads in ultrapure water.

Measurement Method
Measurement of microbiological contamination by means specific enzymatic activity the target microorganisms.

Online Monitoring
The online monitoring of the chemical and physical parameters has proven itself for many years. The monitoring of the microbiological purity, on the other hand, poses great challenges for the operators of ultrapure water systems. The microbiological water quality is often only examined a few times a month.

Online bacteria monitoring systems have emerged as the ideal supplement to laboratory analyses. These measuring devices inform the plant operator in real time about the microbiological load of their water systems. The effects for the plant operator are manifold. The permanent information about the microbiological purity of the water increases product safety and supports compliance with the current GmP requirements. The number of manual analyses can be reduced to the legally required minimum, thereby optimizing the workload of the laboratory staff.

The method of measuring colony formation on agar nutrient solutions focuses on bacteria that can grow selectively on culture media and are capable of forming colonies. Since a colony can consist of one or thousands of bacteria, a statement about the number of bacteria contained in the medium is not possible. Even damaged bacteria that need a long time to become active again cannot be detected.

Quality
The ColiMinder takes a fundamentally different approach. The microbiological water quality is recorded exactly and fully automatically in real time. Moulds, yeasts, algae and bacteria are part of the “interesting” microbiology for online measurement technology. If they are alive, they have a functioning metabolism. If they are not alive, they no longer have a metabolism.
It is precisely this biological property that the ColiMinder® uses and very precisely measures the metabolic activity of the organisms present in the sample. By measuring the activity of the total microbiological load quantitative measurement results are given according to the scientific definition of the enzymatic activity of the corresponding enzyme.

Conclusion
The ColiMinder represents a significant opportunity and innovation for ultrapure water processing, empowering manufacturers to deliver safe, high-quality products to consumers. With its rapid and accurate detection, streamlined quality assurance processes, continuous monitoring, and enhanced regulatory compliance capabilities, this cutting-edge technology revolutionises the way water quality is ensured.

26/7/2023