Page 20 - CIJ May 2023 Digital Edition

Cover Story

Pseudomonas aeruginosa:
The scourge of pharma

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 • Testing of plant extracts, • Chemicals like hydrogen

Biofilms are microorganism animal-derived products peroxide or peracetic acid.
and other substances for
colonies that can form on the Pseudomonas. The type of water system, level
surfaces of pipelines, tanks and • Cleaning and disinfection of of contamination and available
other water system components. equipment skills and resources will influence
Pseudomonas can exist in biofilms the choice of disinfection method.
and proliferate and thrive there. • Adherence to hygiene protocols
(including hand hygiene)
The introduction of Smart solutions
Pseudomonas into water systems Frequency of monitoring While there are numerous
is facilitated by human activity; for potential sources of contamination,
instance, if personnel responsible This will depend on the level of we focus primarily on the most
for maintaining and operating contamination risk and regulatory common source, i.e., water. We
water systems do not practise requirements. In general, high-risk conduct a need-gap analysis to
proper hand hygiene. water systems for Pseudomonas determine the water’s biocide
Pumps and valves used in water contamination such as those used demand, and recommend the type
in pharma should be monitored
systems can become contaminated more frequently. The US FDA of biocide, SOPs for concentration,
with Pseudomonas if not cleaned advises that pharma water systems and dosage schedule based on the
and disinfected adequately. should be tested for the presence of nature of the water source and
Sometimes, Pseudomonas can Pseudomonas at least once per week. biocide demand calculation. We
contaminate the raw materials employ a shock high-dose and
used in water systems, such as continuous low-dose disinfection
compounds and additives. Water disinfection regime to reduce any margin of
methods error and keep the concentration
Quality control • Oxidising agents like chlorine always above the minimal
• Water systems, including and chlorine dioxide: Most inhibitory concentration.
cooling towers, water commonly used. If the client wants to automate
storage containers and water • UV disinfection: May not the process, we also set up the
purification systems, should be appropriate for all water entire engineering infrastructure
be routinely inspected for the treatment systems. with technology for digital
presence of Pseudomonas. This • Ozonation: Can be costly monitoring of dosage levels in real-
can include water sampling and and may require specialised time in relation to water flow and
testing. equipment. other parameters. CIJ

MAY 2023•Clean India Journal
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