SUEZ Water - Water Technologies & Water

Bioburden Testing and Rapid Microbiology Methods

The easier and faster it is to quantify microbial contamination in water systems, raw materials, or finished products, the better your ability to make rapid decisions that impact safety and quality. In pharmaceutical and medical device manufacturing and purification processes, this is critical for patient safety, regulatory compliance, and process efficiencies. But for years, pharmaceutical waters have been released at risk due to waiting five days for bioburden results using growth-based methods. It’s time for faster, reliable methods to provide the information you need to minimize risks.  

Bioburden Testing and Rapid Microbiology Methods

The easier and faster it is to quantify microbial contamination in water systems, raw materials, or finished products, the better your ability to make rapid decisions that impact safety and quality. In pharmaceutical and medical device manufacturing and purification processes, this is critical for patient safety, regulatory compliance, and process efficiencies. But for years, pharmaceutical waters have been released at risk due to waiting five days for bioburden results using growth-based methods. It’s time for faster, reliable methods to provide the information you need to minimize risks.  

Stop waiting for plate counts

Due to the nature of traditional bioburden testing methods (i.e., culture-based methods/ agar plate counts), obtaining results for bacterial contamination found in water loops or production sites can take days. Rapid Microbiological Methods (RMMs) were developed to obtain microbiology results faster, finally giving you the ability to determine whether you have a contamination event in near real-time. With ultra-sensitive, high throughput testing that has a strong correlation to culture-based methods, you can feel confident in your ability to quickly detect microbial contamination and take action to ensure safety, quality, and compliance. 

Stop waiting for plate counts. Get fast detection of microbial contamination and improve your microbiological control.

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Rapid microbiology methods for examining purified water 

Ensure your water system is free of bacterial contamination and save time and resources. By using a rapid microbiological method, you can determine whether your water system or manufacturing process has a contamination event significantly faster than traditional methods. Advanced technologies enable RMMs to have a strong correlation to plate counts, giving you the confidence, you need to take immediate action. 

  • Monitor Water for Injection (WFI) and Purified Water (PW) 
  • Decrease time to results 
  • Increase process efficiencies 

Resources

FAQs

What is bioburden? 

Bioburden refers to the number of viable microorganisms (such as bacteria, yeasts, and molds) present on or within a surface, device, or substrate. In pharmaceutical or medical device manufacturing, bioburden testing is a quality control test used to assess microorganisms that can be present on or in medical devices, final products, water systems, raw materials, intermediates, active pharmaceutical ingredients (APIs), etc. In these manufacturing environments, bioburden can be introduced through people, processes (lack of environmental control or inadequate cleaning processes), and materials – including water used for production. 

Why test for bioburden? 

Bioburden testing, also referred to as microbial limit testing, is a critical aspect of pharmaceutical and medical device quality control to ensure safety of the end user. It is essential for monitoring the manufacturing process, raw materials, and components. Applicable regulatory and guidance documents include but are not limited to: USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests; USP <71> Sterility Tests; USP <1231> Water for Pharmaceutical Purposes; 21 CFR 211; ANSI/AAMI/ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1.  

What are rapid microbiology methods? 

Rapid microbiology methods – also referred to as rapid microbiological methods, rapid micro methods, or RMMs – offer faster results than traditional culture-based methods for bioburden testing. With near real-time information about microbial contamination, organizations can make faster decisions to ensure quality control and manage processes. The use of viability-based flow cytometry as an RMM eliminates or reduced the need to wait on the compendial method for bioburden enumeration (agar plates). By adopting a RMM for bioburden enumeration, pharmaceutical companies benefit from improved process efficiencies. 

 

 

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