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Bioburden Testing and Rapid Microbiology Methods

Bioburden testing, also known as rapid microbial testing, is a crucial quality control process. 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, time to results is critical for patient safety, regulatory compliance, and process efficiencies. But for years, pharmaceutical waters have been released at risk due to waiting several days for bioburden results using growth-based methods. It’s time for faster, reliable methods that provide you with the information you need to minimize risks. ?

Bioburden Testing and Rapid Microbiology Methods

Bioburden testing, also known as rapid microbial testing, is a crucial quality control process. 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, time to results is critical for patient safety, regulatory compliance, and process efficiencies. But for years, pharmaceutical waters have been released at risk due to waiting several days for bioburden results using growth-based methods. It’s time for faster, reliable methods that provide you with the information you need to minimize risks. ?

Stop waiting for plate counts

Types of Traditional Bioburden Testing Methods

  • Membrane filtration
  • Pour plate method (plate count method)
  • Culture-based methods?

How Does Bioburden Testing Work?

Bioburden testing is performed as routine testing to ensure safety, quality, and regulatory compliance during manufacturing. Traditionally, testing for microbial or bioburden contamination at different stages of production requires days to obtain results. This is because samples are incubated for days before the resulting culture can be enumerated.

  1. Personnel collect samples from the manufacturing process or plant
  2. Samples get submitted to Quality Control for bioburden testing
  3. QC Analysts gather samples for testing
  4. A biological safety cabinet (BSC) or laminar flow hood (LFH) is utilized for bioburden testing. The BSC or LFH will be cleaned prior to testing to minimize any contamination risk
  5. Samples and testing materials are introduced into the BSC/LFH for testing
  6. Membrane filtration - The analyst will place a membrane filter cup onto a manifold (vacuum), put the sample into the cup, and filter the sample through.?
  7. Once the sample is filtered, the sample is rinsed with a buffer or diluent
  8. The analyst will transfer the membrane filter to the surface of an agar plate
  9. Upon completion of all samples using this method, the agar plates will be incubated for a specific amount of time to determine if any microbial growth is observed.
  10. Rapid Microbiological Methods (RMMs) or rapid bioburden testing now drastically reduces the time requirements of the above steps, providing a simplified process and faster time to results.

Where is Bioburden Testing Used?

  • Quality control of pharmaceutical manufacturing water
  • Process water testing (water for injection/WFI)
  • Raw material testing
  • In-process testing for pharmaceutical products (upstream, downstream, formulation, fill/finish)
  • Environmental monitoring of process areas (surface, air, etc.)
  • Food and Beverage industry
  • Medical Devices

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.

Portfolio

Rapid microbiology methods for examining purified water?

Ensure your water system is free of bacterial contamination and save time and resources with a rapid microbiological method. 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.?

Rapid Microbiological Methods can allow you to:

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

Resources

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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 microbiological 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 reduces 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.

How can you test for bioburden?
  • Membrane filtration?
  • Plate-count methods
  • Direct plating
  • Rapid Microbiological Methods (RMMs) using flow cytometry
  • Florescence detection
  • Most probable number method (MPN)
How long does it take to perform bioburden testing?

Upon completion of the membrane filtration or pour plate method, samples are incubated for 3-5 days typically, before manually counting for colony forming units (CFUs) or confirming the absence of CFUs on the plate.

How often should bioburden testing be conducted?

This is often sample-dependent, but most times water for injection (WFI) and environmental monitoring samples will be tested daily. Raw material samples are required to be tested for bioburden prior to using them in production campaigns. Bioburden testing for in-process samples and the final product will be needed for each batch prior to release.


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