Where Control Meets Excellence
Empowering Controlled Environments
Our services
Rex Dynamics – Your Trusted Partner in GMP Compliance & Cleanroom Excellence
Consultation
At Rex Dynamics, we specialize in providing top-tier consultancy services for Good Manufacturing Practice (GMP) industries, ensuring compliance, efficiency, and quality at every stage of your operations. With our deep expertise in cleanroom validation, design, training, and documentation, we help businesses achieve regulatory compliance and maintain the highest standards in controlled environments.
GMP Compliance & Regulatory Support
Navigate complex regulatory landscapes with our expert guidance on GMP standards, audits, and risk assessments.
Cleanroom Validation & Qualification
From commissioning to routine requalification, we ensure your cleanrooms meet stringent regulatory requirements, including ISO 14644 and EU GMP Annex 1.
Cleanroom & Facility Design Consulting
Optimize your controlled environments with our strategic design solutions, ensuring efficiency, contamination control, and compliance.
Specialized Training & Workforce Development
Empower your team with tailored training programs on GMP principles, contamination control, and cleanroom best practices.
Comprehensive GMP Documentation & SOP Development
Streamline operations with accurate and regulatory-compliant documentation, from SOPs to validation master plans.
Cleanroom Validation & Calibration
At Rex Dynamics, we specialize in precision calibration services for critical parameters within cleanrooms and GMP-regulated industries. Our focus is on traceability, compliance, and on-site service, ensuring that your controlled environments meet the highest standards.
With extensive expertise in cleanroom measurements and controls, we ensure full compliance with ISO 14644-3 for cleanroom testing and ISO 21501-4 for precise particle counter calibration. Our calibration services are designed to maintain accuracy, reliability, and full traceability, ensuring that your facility meets regulatory and quality requirements.
We provide a comprehensive calibration service tailored to cleanroom environments, covering essential parameters such as:
Particle Counter Calibration according to ISO 21501-4
Temperature & Humidity
Differential Pressure
Airflow & Air Velocity
Particle Count Classification according to ISO 14644-1
HEPA Filter Integrity Testing
Other Critical Environmental Factors
Environmental Monitoring
At Rex Dynamics, we specialize in cutting-edge Environmental Monitoring Systems (EMS) designed for cleanrooms, pharmaceutical manufacturing, biotech, and other GMP-regulated industries. Our solutions ensure precise, real-time monitoring of critical environmental parameters, helping you maintain compliance with regulatory standards such as EU GMP Annex 1, FDA 21 CFR Part 11, ISO 14644, and WHO GMP.
With a focus on accuracy, reliability, and regulatory compliance, we provide end-to-end monitoring solutions that safeguard product integrity and operational efficiency.
Comprehensive Monitoring for Critical Environments
Our advanced EMS solutions provide continuous, real-time monitoring of:
Airborne Particles – Ensuring cleanroom classification compliance
Temperature & Humidity – Controlling environmental conditions for product stability
Differential Pressure – Maintaining contamination barriers
Viable & Non-Viable Air Sampling – Identifying microbial and particulate contamination
CO₂, VOCs, and Other Environmental Factors – Supporting critical processes
Seamless Integration & Compliance-Driven Solutions
Rex Dynamics offers modular, scalable, and fully integrated EMS solutions that seamlessly integrate with existing SCADA, BMS, and LIMS platforms. Our systems provide:
Regulatory-Ready Compliance – Full audit trail, electronic records, and real-time alerts
Data Integrity & Security – 21 CFR Part 11-compliant software with validated reporting
Customizable Alarms & Notifications – Instant alerts for out-of-spec conditions
Cloud & On-Premise Options – Flexible deployment based on your security needs
Expertise You Can Trust
With decades of experience in contamination control and cleanroom monitoring, Rex Dynamics delivers industry-leading solutions tailored to your unique operational requirements. Our team of engineers, validation experts, and compliance specialists ensures seamless installation, validation (IQ/OQ/PQ), and ongoing support to maintain peak performance.
Enhance Your Environmental Monitoring Today
Protect your operations with the most advanced Environmental Monitoring Systems available. Contact Rex Dynamics today to learn how we can help you achieve compliance, efficiency, and peace of mind in your critical environment.
Empowering Controlled Environments
Why Choose Rex Dynamics?
Industry Expertise
Decades of experience in GMP-regulated industries, including pharmaceuticals, biotech, and medical devices
Regulatory Compliance
Alignment with FDA, EMA, WHO, and ISO standards
Turnkey Environmental Monitoring Solutions
We provide end-to-end support for Environmental Monitoring Systems (EMS), from design and installation to qualification and maintenance, ensuring real-time compliance with regulatory standards.
Expert Validation Documentation
Our team specializes in writing precise, regulatory-compliant validation documents, including URS, IQ, OQ, PQ, and Validation Master Plans, ensuring a smooth approval process.
Deep Knowledge in Cleanroom Classification & Validation
We ensure full compliance with GMP Annex 1, ISO 14644-1,2,3, providing expert cleanroom classification, air cleanliness testing, and validation services to maintain a controlled and compliant environment.
Powering the Future of
Controlled Environments
What does REX Dynamics stand for
REX Dynamics embodies precision, reliability, and industry leadership—key attributes of a company dedicated to providing advanced measurement instruments, expert validation services, and comprehensive solutions in contamination control, calibration, and regulatory compliance.
REX, meaning “king” in Latin, conveys authority, excellence, and top-tier performance. In the world of measurements and validation, where accuracy and trust are paramount, REX signifies a commitment to superior quality and industry leadership. It assures clients that they are working with a company that stands at the pinnacle of precision and compliance.
Dynamics reflects adaptability, innovation, and progress – critical attributes in industries that demand cutting-edge technology and evolving standards. It highlights the company’s ability to provide versatile solutions that meet the stringent and ever-changing requirements of sectors like pharmaceuticals, manufacturing, and high-tech industries.
Together, REX Dynamics communicates:
Agility in Innovation – The ability to develop and adapt solutions that address complex, evolving client needs.
Unmatched Accuracy and Reliability – Instruments and services that set the gold standard for precision.
Leadership in Compliance and Validation -A trusted partner in ensuring regulatory adherence and operational excellence.
Dr. Helena Vasquez
Senior Data Scientist & AI-Driven Drug Discovery
Virexion Biotech
Next-generation virology and immunotherapy
“Rex Dynamics helped us reach new heights with their accurate and reliable service”.
Marcus Thorne
Head of Microbiology
Aethera Biomed
Pioneering sustainable and natural drug development
“We recieved an amazing Environmental Monitoring System for our new cleanroom”.
Congratulations, You are one step closer to Contamination controll Excellence
“Unlock the secrets to a cleaner, safer production environment—contact us today for expert insights on controlled environments and contamination control!”
