Insights

Quality to the Core: A Conversation with Andy Burnes

Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global regulatory track record. We recently spoke with Andy Burnes, Senior Microbiologist and Environmental Monitoring Lead. After nearly seven years at Lifecore—including time in both QC Microbiology and Sterility Assurance—Andy offers a detailed look at how environmental and personnel monitoring protect sterile manufacturing.

What does environmental and personnel monitoring involve in practice?

My focus is confirming that our clean rooms remain in a validated state of control. We routinely sample walls, floors, equipment surfaces, and air and, in critical areas, we also sample personnel. We incubate those samples and identify what grows. From there I assess whether results are within limits, and I also trend the data at a high level to catch early signals before they become issues.

Why integrate sterility assurance work with the QC Microbiology team?

Microbiology is a key component of sterility assurance. The QC micro team collects and incubates samples, and I analyze and interpret the resulting data. Working within one group reduces silos and speeds communication. When people who generate, handle, and interpret the same datasets sit together, we act faster on trends and unexpected results.

What happens when results exceed limits?

If counts exceed acceptable levels—especially in critical locations like a filling machine or an operator’s gloves—we open an investigation immediately. I look at recorded video, which product might have been exposed, and what type of organism we recovered to understand whether the source was environmental, personnel-related, or mechanical. Our LIMS software workflow sends notifications to affected teams so we can prioritize and respond quickly.

Corrective actions are situational. Sometimes a gentle reminder or targeted coaching is enough. In other cases, we may increase cleaning frequency, heighten monitoring, or make procedural and engineering changes. The goal is a focused and compliant response that mitigates risk without creating unnecessary burden.

What do new customers tend to find surprising about sterile manufacturing?

Many teams rightly focus on manufacturing equipment—capacity, utilities, and processing steps. What can be surprising is how the clean room itself shapes those decisions. Tools and systems have to be easy to clean, have enclosed or smooth surfaces, and withstand our sanitizers. That often leads to cross-functional collaboration to design enclosures, hide wiring, or adjust materials so that what’s best for manufacturing is also best for the clean room.

Can you share an example of how human factors show up in clean rooms?

Human nature is real in sterile environments, and we plan for it. We even have a defined response for sneezing or coughing in lower-grade areas exit to re-gown and re-enter because something that ordinary can spread organisms. In one investigation, we identified a gowning breach on video review and used it as a coaching moment to reinforce technique. The point is not to blame but to assess product impact, correct quickly and prevent recurrence.

What career advice would you give to someone interested in quality?

Early in my career I worked in a contract lab, and that exposure to strict documentation and diverse scenarios was an excellent foundation for quality-focused work.

Additionally, get hands-on. Don’t investigate solely from your desk. Go to the floor, watch the process, and talk to the people doing the work. You uncover details that never make it into documents.