Effective sterilization has always been a cornerstone of laboratory operations, but today's contamination control programs extend well beyond simply choosing the right sterilization method. As laboratories contend with evolving regulatory expectations, increasingly sophisticated facilities and persistent microbial threats, contamination control has become a strategic discipline that influences operational efficiency, product quality, research integrity and safety. Success depends not only on validated sterilization processes but also on understanding how those processes fit into a comprehensive contamination control strategy.
In this Q&A, Kellie Matzinger, Life Sciences Operations Director with First Onsite, discusses the practical considerations behind selecting sterilization and whole room bio-decontamination technologies, from steam and ethylene oxide to vaporized hydrogen peroxide. The conversation explores the microorganisms that continue to challenge laboratories, the common weaknesses found in otherwise compliant sterilization programs, and how contamination control strategies differ between GMP manufacturing facilities and research laboratories.
Labcompare: How do you evaluate and select between methods like vaporized hydrogen peroxide, ethylene oxide, and steam sterilization for different laboratory applications?
Matzinger: Selection between sterilization and whole room bio-decontamination modalities depends on the intended application, required microbial reduction, material compatibility, operational workflow, and overall contamination control objectives. Traditional sterilizers such as steam autoclaves or ethylene oxide systems are designed to achieve validated sterilization of specific items or materials within a controlled chamber environment and are typically expected to deliver a 10-6 sterility assurance level associated with a 12-log reduction of highly resistant microorganisms. In contrast, whole room bio-decontamination technologies such as vaporized or ionized hydrogen peroxide systems are generally intended to reduce microbial contamination throughout an entire space, including exposed surfaces and equipment within cleanroom or laboratory environments. These technologies are more commonly utilized to support environmental contamination control, aseptic processing, maintenance recovery, and high-level disinfection programs, which typically target 6-log kill. Ultimately, facilities evaluate these technologies based not only on efficacy requirements, but also on material compatibility, cycle repeatability, operator safety, regulatory expectations, and how effectively the technology integrates into broader contamination control and operational workflows.
Labcompare: Which microorganisms or spores present the greatest challenge in lab sterilization today, and how are current technologies adapting to address them?
Matzinger: Some of the greatest microbial challenges in laboratory sterilization and bio-decontamination today continue to be bacterial spores, biofilm-forming organisms, multidrug-resistant organisms, fungi, and certain highly resistant environmental isolates due to their ability to survive harsh environmental conditions and resist routine disinfection practices. Spore-forming organisms such as Clostridioides difficile and Bacillus Spp. remain particularly difficult because of their inherent resistance to many traditional disinfectants and environmental persistence. In addition, biofilms and emerging resistant organisms can create challenges within complex equipment, utilities, and hard-to-reach facility areas. To address these risks, modern sterilization and bio-decontamination technologies have evolved to provide broader-spectrum efficacy, improved distribution, validated cycle development, and enhanced environmental penetration through technologies such as steam sterilization, vaporized hydrogen peroxide, ionized hydrogen peroxide, and other whole room bio-decontamination systems. Facilities are also increasingly integrating enhanced environmental monitoring, sporicidal programs, data-driven trending, and risk-based contamination control strategies to identify and mitigate contamination risks before they result in product impact or operational disruption.
Labcompare: What are the most common failure points you see in laboratory sterilization programs, particularly in otherwise compliant facilities?
Matzinger: Even in otherwise compliant facilities, some of the most common failure points in sterilization and bio-decontamination programs involve inconsistencies in execution, oversight, and integration into broader contamination control strategies. Common gaps include inadequate cycle development or validation, poor equipment placement or distribution studies, insufficient understanding of airflow and room dynamics, incomplete coverage of hard-to-reach areas, and failure to maintain operator training and competency over time. Facilities also frequently struggle with documentation consistency, preventive maintenance, environmental monitoring integration, and ensuring that decontamination processes remain effective following facility modifications, maintenance activities, or operational changes. In many cases, programs appear compliant on paper but lack the operational rigor, scientific justification, and ongoing oversight necessary to consistently maintain a validated state-of-control.
Labcompare: When designing contamination control strategies for GMP vs. research labs, what are the most critical differences in risk assessment and implementation?
Matzinger: When designing contamination control strategies for GMP manufacturing versus research laboratory environments, the most critical differences center around product risk, regulatory oversight, process consistency, and the potential impact on patient safety. GMP environments are highly focused on validated, repeatable processes designed to ensure product sterility, quality, and regulatory compliance, with strict controls surrounding environmental monitoring, personnel practices, documentation, cleaning validation, and contamination prevention. In contrast, research laboratories often operate with greater procedural flexibility, changing workflows, and a broader variety of biological or chemical materials, requiring contamination control programs that are more adaptive and focused on personnel protection, research integrity, and containment of specific hazards. While both environments require strong contamination control practices, GMP facilities are typically driven by reproducibility and regulatory defensibility, whereas research environments often prioritize flexibility, containment, and operational adaptability.
Labcompare: What validation frameworks do you typically use to confirm sterilization efficacy?
Matzinger: Validation of sterilization and bio-decontamination processes typically involves a combination of biological indicators (BIs), chemical indicators (CIs), environmental monitoring data, physical cycle parameters, and documented risk assessments to demonstrate repeatable and effective microbial reduction. Common frameworks incorporate standards and guidance from organizations such as International Organization for Standardization, United States Pharmacopeia, Parenteral Drug Association, and regulatory expectations under EU GMP Annex 1 and FDA guidance. Sterilization validation often focuses on achieving validated sterility assurance levels through BI challenges and cycle development studies, while whole room bio-decontamination programs typically evaluate distribution, contact time, airflow dynamics, environmental conditions, and validated log reduction performance across representative worst-case locations. Increasingly, facilities are also integrating ongoing environmental monitoring, trending, and periodic requalification activities to support continuous state-of-control and long-term contamination control effectiveness.
Labcompare: How do evolving expectations under current Good Manufacturing Practice influence sterilization validation?
Matzinger: Evolving expectations under current Good Manufacturing Practice (cGMP) are driving sterilization and bio-decontamination validation programs toward more risk-based, data-driven, and scientifically justified approaches. Regulators are increasingly expecting facilities to demonstrate not only that a cycle can achieve the required microbial reduction, but also that the process is repeatable, well understood, properly documented, and integrated into the site’s broader Contamination Control Strategy (CCS). Greater emphasis is being placed on cycle development, worst-case validation conditions, environmental monitoring integration, operator training, periodic requalification, and ongoing state-of-control rather than one-time validation activities alone. As frameworks such as EU GMP Annex 1 continue evolving, facilities are being pushed to treat sterilization and bio-decontamination as continuously managed contamination control processes rather than isolated compliance exercises.
Labcompare: Can you address how a shift from reactive decontamination to preventive contamination control impacts lab uptime, deviation rates, or batch loss?
Matzinger: The shift from reactive decontamination to proactive contamination control can have a significant impact on operational performance by helping reduce downtime, deviation rates, investigations, and potential batch loss. Rather than responding to contamination events after they occur, facilities are increasingly implementing preventive strategies such as enhanced environmental monitoring, validated bio-decontamination processes, improved personnel training, and risk-based contamination control programs designed to identify and mitigate risks earlier. This proactive approach not only strengthens regulatory compliance and contamination prevention, but also helps improve operational efficiency, production continuity, and overall facility resilience by minimizing disruptions that can impact product quality, timelines, and manufacturing capacity.
Labcompare: You emphasize translating microbiological principles into practice. Can you walk through a specific case where theoretical understanding directly improved a facility’s sterilization outcomes?
Matzinger: One example involved a facility experiencing inconsistent bio-decontamination results within a cleanroom suite following maintenance shutdowns and equipment interventions. While the decontamination cycles themselves appeared compliant on paper, environmental monitoring data continued showing intermittent recoveries in certain areas after the rooms were returned to service. By applying microbiological principles related to airflow patterns, microbial harborages, and material transfer risks, the investigation identified that temporary maintenance activities and equipment repositioning were disrupting airflow and creating areas with reduced decontamination exposure. Adjustments were made to room preparation procedures, equipment positioning, cycle development, and post-maintenance recovery protocols, while personnel training was expanded to better address contamination risks associated with maintenance and restart activities. Following these changes, the facility observed improved consistency in bio-decontamination performance, reduced environmental excursions, fewer investigations, and improved operational readiness after shutdown events.
Labcompare: Are there emerging sterilization technologies that could reshape contamination control in the coming years?
Matzinger: Several emerging sterilization and bio-decontamination technologies are expected to reshape contamination control strategies over the coming years as facilities continue moving toward more proactive, automated, and data-driven operations. Increased adoption of advanced hydrogen peroxide technologies, rapid microbiological methods, continuous environmental monitoring systems, UV-C and pulsed light technologies, and automated or robotic decontamination platforms are all gaining momentum, particularly within pharmaceutical, biologic, and advanced therapy ‘core’ environments. Many of these technologies are being evaluated not only for microbial efficacy, but also for their ability to reduce operator dependency, improve repeatability, shorten downtime, and better support modern Contamination Control Strategies (CCS). At the same time, emerging technologies are increasingly being designed with greater emphasis on Environmental Health & Safety (EH&S), helping reduce concerns surrounding chemical exposure, operator contact, room re-entry limitations, and other worker safety risks traditionally associated with some sterilization and decontamination processes.
About the interviewee
Kellie Matzinger is the Life Sciences Operations Director, North America, with First Onsite. Matzinger brings over 25 years of experience in microbiology, sterilization, decontamination, and validation. Her technical expertise spans all major sterilization modalities. In recent years, Matzinger’s work has focused on hydrogen peroxide technologies, particularly in the application of high-level disinfection and bio-decontamination for critical environments. She is widely recognized for her ability to translate microbiological principles into practical contamination control solutions.