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.

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!”

Rex Dynamics Contact Form
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Name
REX Dynamics AB
Eriks Väg 1
749 52 Grillby
Sweden
E-mail:info@rexdynamics.se
Phone:+46 768 58 1003
Organization Number:559528-5320