Leho Mikko Lehto is a professional with over five years of experience in cleanroom contamination control and cleanroom technologies. Based in Finland, he is available for global consulting.

He is the founder of Leho cleanroom consulting.

Areas of Expertise

• Validation and Qualification: Problem-solving, validation, and qualification in cleanrooms.

• Cleanroom Operations: Expertise in cleanroom operations, including the build, startup, and commissioning of new facilities.

• Biocontamination Control: Aseptic manufacturing for the pharma and biopharma industries, as well as biomedical device manufacturing.

• Air Simulation: Air simulation and visualization.

• HVAC Systems: HVAC, fume hoods, biosafety cabinets, isolators, and RABS.

• Standards and Regulations: Thorough knowledge of EU-GMP and its related annexes, such as Annex 1, and international standards like ISO 14644.

• Personnel and Equipment: Cleanroom gowning principles and materials.

• Industry Focus: High-fidelity electronics and other industries requiring controlled environments.

Lehto is one of finnish key figures in international cleanroom standardization, serving as the head of delegation (YTL/SR 028) for ISO/TC 209 "Cleanrooms and associated controlled environments". This committee is responsible for developing international standards, including the ISO 14644 series. He is also a member of ISPE and R3 Nordic.