From pharmaceutical manufacturing and compounding pharmacies to medical device production and electronics assembly, Setra delivers real-time environmental monitoring that ensures compliance, protects product integrity, and supports operational excellence. Monitor pressure, temperature, humidity, and particles with confidence—powered by Setra CEMS™, Setra FLEX™, and high-accuracy sensors.
Pharmaceutical cleanrooms are highly regulated environments where contamination control is critical to product safety and efficacy. These spaces must comply with cGMP, EU GMP, and FDA 21 CFR Part 11 standards, requiring continuous monitoring and documentation of environmental conditions. Setra’s solutions help pharmaceutical manufacturers maintain ISO-classified cleanrooms with real-time data, secure reporting, and scalable sensor networks.
Compounding pharmacies must maintain sterile conditions to ensure the safety and effectiveness of customized medications. Compliance with USP <797> and <800> standards is essential, requiring precise control of air pressure, temperature, humidity, and particulate levels. Setra’s monitoring systems automate compliance, reduce manual errors, and provide real-time visibility into pharmacy environments.
Medical device cleanrooms require strict environmental control to ensure product quality and patient safety. These facilities must comply with ISO 14644, ISO 13485, and FDA 21 CFR Part 11 standards. Setra’s monitoring solutions provide automated tracking of critical parameters and in-room feedback to support cleanroom integrity and regulatory compliance.
Electronics cleanrooms are designed to prevent contamination that can damage sensitive components and reduce product yield. These environments require precise control of particulate levels, temperature, humidity, and electrostatic discharge. Setra’s monitoring systems provide real-time insights and centralized data management to maintain optimal conditions and support ISO compliance.
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