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 quality and regulatory track record. From utility systems and air handling units to pest control and emergency power redundancy, the work of Lifecore’s Facilities Management organization plays a critical role in protecting product quality and patient safety. For this installment of our Quality Series, we sat down with Mike Puzak, Senior Facility Manager, to explore the engineering and operational safeguards built into Lifecore’s facilities—and why even the smallest detail matters.
To begin, can you share your primary areas of responsibility?
I oversee all critical utility systems that support Lifecore’s cleanrooms and manufacturing environments, including managing air handling equipment, compressed air, water for injection, pure steam generation, and rooftop units essential to delivering the correct air volume and purity required for each cleanroom classification. In addition, I am responsible for the broader physical facilities, ensuring each space operates as designed to support GMP manufacturing.
What parts of a facility do people not immediately consider to influence quality?
While people often associate cleanliness or sterility with the cleanroom space itself, many elements behind the scenes also impact product quality. Cleanrooms are engineered by grade, and their design dictates airflow, equipment needs, and detailed cleaning regimens. Autoclaves sterilize equipment subassemblies, and HEPA pass-through systems allow critical materials to enter controlled environments safely. These systems work together to protect both products and personnel.
What are the biggest challenges in maintaining facility protection and uptime?
The most significant challenge is keeping equipment in a constant state of readiness. Preventive maintenance must be timely, and critical systems—including water, steam, compressed air, refrigeration, and storage—are fully redundant. Lifecore’s emergency generators provide 100% backup power within seconds of an outage and are tested monthly under load to ensure reliability.
How is preventive maintenance structured at Lifecore?
Preventive maintenance (PM) ensures equipment readiness and compliance. Hundreds of PM tasks are scheduled monthly, quarterly, semi-annually, or annually. A User Requirement Specification is created before new equipment arrives, defining what the equipment must do and outlining its PM needs. PM tasks are tracked and assigned through a computerized system, and completed documentation is retained for auditability.
What role does pest management play in maintaining facility integrity?
Pest management is a vital aspect of compliance. Lifecore maintains a detailed SOP governing pest control, contractor responsibilities, and pesticide application. Exterior bait stations, interior traps, and insect light traps create multiple layers of protection, preventing pests from approaching controlled environments. Regular contractor inspections and quarterly review meetings help identify trends and ensure a rapid response.
Changing directions a bit–you are also very involved in our safety program. What does safety culture look like at Lifecore?
Years ago, our leadership realized that employee well-being was vital to our ability to produce the highest quality products in an efficient manner. Employees may have difficulty focusing on product safety if they are concerned about their own safety while performing tasks. Beyond that, our leaders knew that prioritizing employee health and safety was the right thing to do.
In support of this belief, Lifecore has maintained Minnesota Safety and Health Achievement Recognition Program (MNSHARP) certification for more than 20 years. MNSHARP is a voluntary, Minnesota state program that operates under the umbrella of the federal Occupational Safety and Health Administration (OSHA).
The MNSHARP program “recognizes companies whose managers and employees work together to develop safety and health programs that go beyond basic compliance with all applicable OSHA standards, and result in immediate and long-term prevention of job-related injuries and illnesses.” (MN Dept. of Labor and Industry website). Following a series of consultation visits, Lifecore improved a multitude of business practices, including routine department safety audits to increase employee ownership, a comprehensive new hire on-boarding process, and team-based incident and near-miss investigations.
What should someone know if they're considering a career in facilities or maintenance within a pharmaceutical environment?
Working in a regulated environment requires patience, precision, and a strong understanding of impact. Documentation must follow strict GMP principles, and tasks such as entering cleanrooms or bringing in tools must adhere to defined procedures. Gowning steps must be followed exactly, and changes to spaces or processes require thorough, risk-based evaluation. You need to recognize it’s just going to take longer to complete tasks in order to do them properly.