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Tackling waterborne microorganisms in pharma manufacturing

In the pharma industry, Pseudomonas is an increasingly common source of contamination, especially in water-based systems such as cooling towers, water storage containers and water purification systems. Its presence in pharmaceutical products poses a grave threat to human health. Detection of Pseudomonas contamination can result in product recalls, regulatory action and reputational injury to the manufacturer. To prevent this, manufacturers must implement stringent quality control measures such as routine monitoring of water systems, cleansing and disinfection procedures, and product testing, writes Dr Rachna Dave, Founder & CEO, MicroGO LLP.

Source of contamination

Biofilms are microorganism colonies that can form on the surfaces of pipelines, tanks and other water system components. Pseudomonas can exist in biofilms and proliferate and thrive there.

The introduction of Pseudomonas into water systems is facilitated by human activity; for instance, if personnel responsible for maintaining and operating water systems do not practise proper hand hygiene.

Pumps and valves used in water systems can become contaminated with Pseudomonas if not cleaned and disinfected adequately. Sometimes, Pseudomonas can contaminate the raw materials used in water systems, such as compounds and additives.

Quality control

  • Water systems, including cooling towers, water storage containers and water purification systems, should be routinely inspected for the presence of Pseudomonas. This can include water sampling and testing.
  • Testing of plant extracts, animal-derived products and other substances for Pseudomonas.
  • Cleaning and disinfection of equipment
  • Adherence to hygiene protocols (including hand hygiene)

Frequency of monitoring

This will depend on the level of contamination risk and regulatory requirements. In general, high-risk water systems for Pseudomonas contamination such as those used in pharma should be monitored more frequently. The US FDA advises that pharma water systems should be tested for the presence of Pseudomonas at least once per week.

Water disinfection methods

  • Oxidising agents like chlorine and chlorine dioxide: Most commonly used.
  • UV disinfection: May not be appropriate for all water treatment systems.
  • Ozonation: Can be costly and may require specialised equipment.
  • Chemicals like hydrogen peroxide or peracetic acid.

The type of water system, level of contamination and available skills and resources will influence the choice of disinfection method.

Smart solutions

While there are numerous potential sources of contamination, we focus primarily on the most common source, i.e., water. We conduct a need-gap analysis to determine the water’s biocide demand, and recommend the type of biocide, SOPs for concentration, and dosage schedule based on the nature of the water source and biocide demand calculation. We employ a shock high-dose and continuous low-dose disinfection regime to reduce any margin of error and keep the concentration always above the minimal inhibitory concentration.

If the client wants to automate the process, we also set up the entire engineering infrastructure with technology for digital monitoring of dosage levels in real-time in relation to water flow and other parameters.

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