Briana Nunez and Hayden Skalski - Veolia Water Technologies & Solutions Sievers Instruments
For decades, pharmaceutical and biopharmaceutical industries have waited for days to visually inspect microbiological colonies on agar plates to determine results. These results are not only slow to obtain, but they also leave room for improvement when it comes to data integrity. Subjective decisions, lack of digital traceability, and a diminished interface with databases for actionable decisions remain concerns when discussing data integrity and the microbiology lab. Throughout the pharmaceutical and biopharmaceutical industries, more and more companies are implementing Rapid Microbial Methods, or RMMs. These methods not only provide companies with results faster than compendial plate counts, but the modern instruments deployed also improve data integrity. Maintaining valid data integrity within these industries is vital to the manufacturing process to preserve quality standards.
A Google search on bacteria and fungi colony morphology types will yield hundreds of websites, articles, and images. Colonies from these organisms can be used to create beautiful agar art with vibrant colors and various textures. But what happens when someone from the microbiology lab is tasked with manually counting these colonies? As most microbiologists know, plating comes with inherent variability due to colony size, shape, texture, and quantity. Most days, microbiologists will get lucky and the colonies/colony forming units (CFUs) on agar plates will be relatively easy to count. Other days, microbiologists encounter swarming from organisms like Bacillus or Pseudomonas, colonies growing into the agar, or colonies from a mixed culture blending to make it difficult to determine where one colony stops and the next begins. Due to the potential subjective decisions in counting colonies, most companies utilize the “four eyes” principle to approve and report results. Traditional bioburden methods such as membrane filtration and pour plate require the agar plates to be incubated for a duration of time at a set temperature. Upon completion of testing, microbiology analysts are required to put the agar plates in specified incubators per internal SOPs. This task can often lead to incorrect incubation temperatures for set samples that were tested due to analyst error. Labs will also implement the four eyes principle for this task to prevent incorrect incubation temperatures and deviations. Employing a rapid microbial method to report colony counts saves the microbiologist time and can decrease errors by reducing manual counting of CFUs and the need for a second person to approve results and check incubation parameters.
How can a company keep electronic records that comply with 21 CFR Part 11 regulations when the sample analysis is completed manually? Of course, sample results can be loaded into a computer creating the start of an audit trail and allowing for digital signatures, but this requires additional time to transcribe plate counts into a repository. Allowing an RMM to automatically create digital records of results using an instrument reduces the need to manually enter results into a computer. Obtaining digital results from an instrument also reduces the chance of transcription errors being entered into a results repository. Furthermore, using an RMM that adheres to 21 CFR Part 11 regulations will certify accuracy, integrity, and data security with an audit trail to provide a comprehensive record of actions taken. In a busy microbiology lab, manual plate counts and transcription of data can often take hours to finish, with multiple chances for human error during that process. Reducing the need for manual bioburden counts and data transcription will put a microbiology lab in a proactive state rather than reactive. This means that implementing an RMM will help prepare a lab to overcome traditional pain points seen in manual bioburden methods.
Receiving microbiology results faster enables actionable decisions to be taken faster, which is the goal of any microbiology lab. Process analytical technologies (PAT) are used to routinely measure and monitor data. If the data is not managed well, the data becomes unusable. Allowing an RMM to interface directly with a database like DataShare Elite allows data to be managed in a central location in real time. Trending and tracking data over time gives companies the ability to make faster, informed, and actionable decisions. In addition, compiling data in a centralized database gives employers the ability to track and trend results by an analyst. This can be useful when determining if certain analysts require more training.
Overall, implementation of a rapid microbiology method can help streamline a company’s manufacturing process and contribute to improved efficiency, quality, and data integrity. Biopharmaceutical companies monitor not only bioburden results of samples but also microbiological samples of their process areas such as air and surfaces (known as environmental monitoring). Monitoring of the manufacturing suites and products takes time to yield results, which can often hold up the release of product and delay production. A rapid method will benefit a company by accelerating the time of release for a product while maintaining the data integrity standards the industry strives for. Adopting RMMs not only improves time to results and the quality of an analyst’s time, but also improves quality values by adhering to the rigorous standards the industry requires.
Author Biographies
Briana Nuñez is a Microbiology Technical Sales Engineer for Sievers Instruments, 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.
Hayden Skalski is the Lead Life Sciences Product Application Specialist for the Sievers Instruments product line, specializing in bacterial endotoxins testing (BET). Hayden has over 8 years of experience in the pharmaceutical industry and Quality Control Microbiology and has presented on numerous topics surrounding endotoxin testing. Previously, Hayden held roles at Charles River Laboratories, Regeneron and Novartis, validating and executing method development protocols for endotoxin testing, providing customer support, troubleshooting and supporting high-volume product testing. Hayden has a B.S. from the University at Albany (SUNY) in Biology.
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