Manufacturers of biotherapeutics and medical devices must perform a wide range of quality controlmicrobiology tests to ensure both products and clean room manufacturing facilities meet strict regulatory guidelines on contaminant control. The recent rapid growth in the number of these sterile products entering the market means that increased regulatory attention is now being paid to how QC data is collected, managed and stored. Many laboratories still rely on paper-based environmental monitoring approaches, however, these are prone to human error and often require considerable amounts of time to collect and interpret this information. In this article, we look at how the latest paperless systems are improving the reliability and effectiveness of environmental monitoring from a QC microbiology perspective, and how this technology can seamlessly integrate with laboratory information management systems (LIMS) to bridge the communication gap between QC and product manufacture.
THE NEED FOR STERILE MANUFACTURING ENVIRONMENTS
Microorganisms such as bacteria, fungi and mold can be found everywhere: in the air, in water, on surfaces, and on our clothes, hair and skin. But the presence of even trace amounts of these biological contaminants in biotechnology products, such as biological medicines and medical devices, can significantly impact drug efficacy and device performance and can have serious consequences for patient health. Bacterial endotoxin contamination in parenteral pharmaceuticals and implantable devices, for instance, can result in life-threatening conditions such as septic shock if accidentally introduced into a patient’s cardiovascular or lymphatic systems. Even endotoxins from dead bacterial cells introduced to the product during the manufacturing process can compromise patient safety when used clinically.
To minimize the risk of contamination, the FDA requires manufacturers to demonstrate that production and packaging facilities and representative product samples are free from these types of contaminants. To do this, regular sampling of the laboratory environment must be undertaken. And because microorganisms can contaminate a wide variety of surfaces and environments, an extensive range of samples must be collected, from air and water specimens through to surface swabs of benchtops, instruments and personal protective equipment. These samples — often numbering in the thousands per month — are incubated on agar plates and analyzed for microbial growth.
Many laboratories still use paper-based systems to schedule the sampling process and manage the collection of this environmental data. However, with such a large volume of samples to be taken, organizing, retrieving and interpreting this information can be challenging.
Paper-based systems are inherently inefficient and not ideally suited to the demands of sterile manufacturing environments. All materials, including paper, must first be sterilized before entering the clean room, adding additional, time-consuming stages to data-collection workflows. When you also consider that paper records and worksheets must often be manually logged into spreadsheets for data to be shared or analyzed, it becomes clear that paper-based systems unnecessarily burden laboratory workloads and are more prone to errors. And with an increased regulatory focus on data integrity, paper-based workflows simply don’t provide the level of accuracy, traceability and completeness that regulatory authorities demand.
PAPERLESS SOLUTIONS OFFER ENHANCED DATA INTEGRITY
Purpose-built electronic environmental monitoring systems overcome many of the limitations associated with paper-based approaches. The latest paperless environmental monitoring systems possess a number of features that make QC testing more convenient for users, while helping laboratories reach the highest levels of data integrity and meeting regulatory guidelines.
Using paperless systems, measurements of incubation temperature or pH can be taken directly using probes that can be connected to the device, minimizing the potential for human error and ensuring data collection is always accurate. Electronic systems can further reduce errors by guiding users through data-collection protocols, preventing process deviations and prompting users to complete missing information prior to submission in ways that paper-based approaches cannot enforce. These systems can help ensure laboratories comply with regulatory guidelines by recording all necessary measurements according to standard operating procedures.
With a wide range of locations and samples to test, environmental monitoring systems for QC microbiology must be mobile. Lonza’s MODA-EM system, for instance, is built using robust hardware that can withstand regular sterilization, while allowing users to move between data collection points around the clean room. Systems based on printed barcode labeling — made possible through the use of easily sterilized label printers and portable barcode readers — can help make data collection quick and convenient for users, while ensuring data is accurate, organized and traceable.
REAL TIME DATA ANALYSIS FOR A RAPID RESPONSE
With patient safety of primary concern for biotechnology manufacturers, the discovery of laboratory or batch contamination can cause significant and costly disruption to production workflows — not to mention possible regulatory action or reputational damage. By combining environmental monitoring systems with LIMS, such technology enables QC microbiology laboratories to analyze and share test results in real time, allowing manufacturers to take corrective and preventative action (CAPA) at the earliest opportunity.