Environmental monitoring and routine testing are key tools in understanding a production site’s bioburden
Dr. Ute Krone, an industrial microbiologist, has worked at Procter & Gamble since 2005. Ute has over 26 years of industry experience. She studied biology at the University of Marburg where she received her PhD, and completed her post-doctoral work at the University of Minneapolis. Dr. Krone has worked in consumer care microbiology since 1994. We connected with Ute ahead of her Charles River Webinar, which was held on January 28th, to talk about how accurate identification impacts quality control microbiology.
Rachael: Routine environmental sampling and raw materials testing may sometimes reach action or alert limits requiring the need for microbial identification. From your perspective, what are the most important aspects toward understanding the requirements needed to maintain a quality-controlled manufacturing facility?
Ute: An Environmental Monitoring program and routine testing is the basis of awareness and understanding of the bioburden that is present in a production site. The awareness is gained by identifying and tracking production site organisms. You must understand that the facility you are working in is not a 100% sterile environment for many industries. Knowing the facilities’ microflora and being able to control and manage it is key. It is extremely important to understand the organisms that the facility will naturally encounter and take appropriate actions to reduce the bioburden. Having the knowledge of what materials enter the facility and what materials are used in the manufacturing process also requires an understanding of all specifications of these raw materials, typically 100cfu per gram or mL, for example.
Raw materials have certain limits which may also exclude certain microorganisms. You would not want to detect certain indicator organisms or objectionable organisms that could negatively impact product quality or consumer health. So, knowing natural microflora, compared to microorganisms flagged as objectionable, is required. Since there are no exact specifications for environmental monitoring samples, microbiology needs to make sure they are tracking the correct organisms to maintain facility control and make certain there is not an increase of microorganisms within the manufacturing building.
Rachael: If a contamination event is discovered, what method of identification would be most valuable in supporting the determination of root cause?
Ute: It is very important to always use an identification method that is as exact as possible. Depending on the organism’s identification result, the product release decision is made. If you utilize inferior identification methods—those that do not use precise science—they may not yield a correct result. You are then either scrapping a product batch—which costs the company a tremendous amount of money—based on an incorrect ID, or releasing products at risk of sending product potentially contaminated with pathogens out to consumers. Working with identification methods that may not yield accurate results could create a big loss for the company that otherwise could have been prevented. If you use an identification method like 16S rRNA sequencing, which is totally correct, you can accurately understand your identifications and confidently release safe products. Phenotypic identification methods are dangerous as they will give an ID result; however, it could give a totally incorrect ID forcing an incorrect decision to be made.
Rachael: Given your industry knowledge and expertise, what is the most critical aspect within microbiology to be certain cGMP and regulatory guidelines are maintained? What can manufacturing personnel do to ensure this?
Ute: Watch out for facility risk areas where bioburden can get into the products. Follow all company requirements and regulatory requirements. It is crucial that people are truly reporting the results of all microbiological testing and digging into the details of results when needed. Proper investigating and an understanding why an out of specification result has occurred is critical every time. Microbiology needs to exactly understand the microorganisms that are recovered, and not just list a species name. Does the identification make sense and what are the potential root causes? Is it objectionable, is it a pathogen? In addition to the numerical count perspective, and the number of colony-forming units (CFU), the analyst must also elucidate what the organism is, and further understand where it came from to avoid reoccurrence. An accurate organism identification will point you in the right direction and indicate whether it is from the environment, from outside air, or from a liquid source, for example a water organism. The ID assists with the investigation to determine root cause, control and to mitigate the issue, and prevent it from happening again.
Rachael: What do you feel are the biggest challenges currently facing the consumer care and pharmaceutical industry?
Ute: Qualification of personnel handling the testing as required and following all protocols and procedures to produce the product efficiently, and effectively ensure that safe products are sent to market. Regulatory requirements and microbiology testing guidance are changing and becoming more stringent. Maintaining compliant and current manufacturing and laboratory processes is an ongoing challenge that all industry personnel face.
To learn more about how Charles River’s Microbial Identification Services can support your facility just as it has Ute’s and many others, Click here.