Briana Nuñez- Veolia Water Technologies & Solutions, Sievers Instruments.
Pharmaceutical and biopharmaceutical manufacturers need faster data related to microbial contamination in all aspects of production. Relying on growth-based methods that take days is not fast enough to make actionable changes when drugs and potentially patient lives are at risk. Implementation of Rapid Microbiological Methods (RMMs) such as the new Sievers rapid bioburden analyzer can provide timely trend analysis and early warnings of contamination events in various stages of the manufacturing process. From screening raw materials in the receiving docks to at-line monitoring of the water system, and including final quantitative results from the QC lab, nearly every area of a manufacturing facility can benefit from monitoring contamination control processes with a rapid bioburden analyzer.
Ultra-sensitive, high throughput testing is possible with the Sievers bioburden system, a RMM that has a strong correlation to plate counts. This enables manufacturers to quickly detect microbial contamination and have confidence in their actions to ensure safety, quality, and compliance.
Screening of Raw Materials in Receiving
Maintaining acceptable quality of a final product relies on the quality of the incoming raw materials. Raw materials used in manufacturing are susceptible to microbial contamination and must be assessed before they can be released to production. Using the novel technology in the Sievers rapid bioburden analyzer, these raw materials can be analyzed in less than 45 minutes without extensive incubation to determine contamination levels. Instead of transporting samples to the lab to complete microbial limit testing - which requires waiting days for results - simple to complex, filterable raw materials can be analyzed immediately after receiving. Rapid screening of incoming materials decreases the time needed before releasing raw materials into production with assurance of their microbial levels.
At-line Monitoring
Implementation of the Sievers rapid bioburden system in close proximity to a sampling site provides at-line monitoring for faster information related to contamination events, sanitization of assets, etc. Some applications that would benefit from at-line rapid monitoring include CCPs, or Critical Control Points, on water loops. CCPs are often found on the return leg of a water loop and indicate the quality of the water found within the interior of the water loop. Monitoring CCPs provides an early warning of a contamination event inside the water loop.
Another critical application is at-line monitoring of buffers or effluent from purification columns. Over sanitizing purification columns reduces their effective lifespan, causing underutilization of a high value asset. Without rapid microbial detection, columns are assumed to be contaminated and sanitized at the harshest level. Instead, accurate and fast detection using RMMs enables proper sanitization protocols suitable for contamination levels inside the column. This can significantly increase the lifespan of the asset.
Inside the QC Lab
The Sievers rapid bioburden analyzer is considered to be an alternative method to the compendial plate count. Like any alternative method, a validation will initially be required to prove suitability for purpose in release testing. For quicker adoption, users can opt to explore a range of applications such as kill-rate studies, preservative efficacy testing, quantitative testing of reference microorganisms,and culture media qualification in parallel to existing QC methods. Doing so will allow the new instrument to evolve into a validated alternative method based on the user’s application priority.
Conclusion: Improving Speed and Decision Making with RMMs
The Sievers rapid bioburden analyzer can be used for many applications, in addition to water testing. Implementing rapid bioburden testing in various locations inside a manufacturing site can play a key role in decision making and manufacturing agility, resulting in better contamination control strategies, cost savings, and speed.
Whether for faster release of raw materials, optimization of protocols to prolong the lifespan of expensive assets, or near real-time monitoring of products in the QC lab, rapid microbiological methods can quickly provide critical information to maintain control of production. Faster determination of whether a contamination event has occurred allows for immediate action to preserve and protect products, giving manufacturers confidence that their products meet the highest quality standards for customers.
Author Biography
Briana Nuñez is a Microbiology Technical Sales Engineer for the Sievers Instruments product line, part of Veolia Water Technologies & Solutions. She was previously the Lead Researcher within the Sievers Instruments Microbiology Center of Excellence in Tucson, Arizona. Briana is responsible for supporting the implementation of automated endotoxin testing in microbiology labs and has participated in research and development of Rapid Microbiological Methods (RMMs) for bioburden analysis. Briana also plans and conducts laboratory experiments, provides training, delivers presentations and product demonstrations at customer sites, and assists in customer support. Briana holds a B.S. from State University of New York at Purchase College in Biology.
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