Precision Validation. Proven Excellence.
Expert consulting for pharmaceutical, medical, and laboratory facilities. We ensure your cleanrooms and equipment exceed industry standards through rigorous validation.
- Services
What We Provide
Comprehensive validation solutions for cleanrooms and equipment. We ensure your facilities meet safety standards and regulatory compliance requirements.
Complete validation of controlled environments ensuring ISO compliance. We test air quality, particle counts, and environmental conditions for pharmaceutical facilities.
Rigorous testing of laboratory and manufacturing equipment. Verification of installation, operation, and performance meeting GMP and FDA regulatory standards.
Expert guidance on regulatory requirements and quality management systems. We help navigate FDA, ISO, and GMP compliance with comprehensive documentation.
Scheduled validation testing and detailed reporting. Regular environmental monitoring and audits ensuring continuous compliance and optimal facility performance.
Strategic consulting to enhance efficiency and reduce costs. We analyze workflows and implement improvements while maintaining strict compliance standards.
- About
Who We Are
Aeris Validation Services is a premier provider of cleanroom certification and equipment validation solutions for pharmaceutical, medical device, and biotechnology industries. Since our founding, we have been committed to delivering excellence in validation services that protect lives and ensure regulatory compliance.
- Why Us
Delivering Validation Excellence
Efficient validation processes minimizing downtime and disruption. Quick response times for urgent certification needs while maintaining thorough testing protocols and quality standards.
15+ years specializing in pharmaceutical and medical facility validation with comprehensive regulatory compliance knowledge.
99% success rate meeting FDA, ISO, and GMP standards through rigorous testing protocols.
State-of-the-art equipment and digital systems ensuring precise measurements and comprehensive validation data.
Dedicated support team building long-term relationships focused on your operational success and compliance.
Detailed reports and certification packages simplifying audits and regulatory inspections with full traceability.
Efficient processes minimizing downtime while maintaining thorough testing and quality assurance standards.
Your Trusted Partner in Validation Excellence
Comprehensive cleanroom certification and equipment validation ensuring safety, quality, and regulatory compliance for critical pharmaceutical and medical facilities.
- Process
How We Work
Our streamlined four-step validation process ensures comprehensive compliance while minimizing disruption to your facility operations and timeline.
Initial Consultation
Comprehensive facility assessment and customized validation plan development based on your specific requirements and regulatory compliance needs.
Detailed Inspection
Certified technicians perform thorough facility and equipment inspections, documenting conditions and identifying compliance requirements.
Rigorous Assessment
Advanced testing protocols using state-of-the-art equipment to measure environmental conditions and validate compliance with regulatory standards.
Process-System Certification
Comprehensive certification documentation with detailed reports, compliance certificates, and complete audit trails for regulatory compliance.
- Coverage
Where We Serve
Serving pharmaceutical, medical, and biotechnology facilities throughout the United States with comprehensive validation services.
- FAQ
Need Answers?
Find answers to common questions about cleanroom certification, equipment validation, compliance requirements, and our validation process.
Timeline varies based on facility size and complexity. Typically, initial cleanroom certification takes 2-4 weeks from consultation to final documentation. Smaller facilities may be completed in 1-2 weeks, while large pharmaceutical facilities may require 4-6 weeks. We provide detailed timelines during the initial consultation.
Pricing depends on facility size, validation scope, equipment types, and service level required. We offer transparent, customized quotes after an initial assessment. Contact us for a free consultation and detailed pricing. Most cleanroom certifications range from $5,000 to $25,000, while equipment validation varies by complexity.
We follow all major industry standards including FDA 21 CFR Part 11, ISO 14644 (cleanroom standards), GMP (Good Manufacturing Practice), and cGMP regulations. Our validation protocols meet requirements for pharmaceutical, biotechnology, medical device, and laboratory facilities, ensuring complete regulatory compliance.
ISO 14644 standards require cleanroom re-certification every 6-24 months depending on classification and risk level. Most pharmaceutical facilities re-certify annually. We recommend quarterly routine testing between certifications to maintain optimal performance and catch potential issues early, reducing downtime and compliance risks.
We provide comprehensive validation services including cleanroom certification, equipment validation, compliance consulting, routine testing and reporting, and process optimization. Our services cover pharmaceutical, biotechnology, medical device, and laboratory facilities, ensuring full compliance with FDA, ISO, and GMP standards.
Get Trusted
Validation Experts,
Process Made
Simple
- Testimonials
What Clients Say
Trusted by leading pharmaceutical, biotechnology, and medical device companies nationwide. Hear directly from our satisfied clients.
- Insights
Latest Industry Updates
Stay informed with the latest cleanroom validation standards, regulatory updates, and industry best practices from our expert team.
