What are HVAC Validation Services?
Our services include DOP/PAO filter testing, airflow velocity and differential pressure analysis, non-viable particulate testing, and cleanroom classification per ISO 14644, ensuring sterility and compliance.
HVAC Validation for Cleanroom Compliance
Ensuring Sterility and Environmental Control
At Indivirtus Healthcare Services Pvt. Ltd., our HVAC Validation services ensure cleanroom compliance through comprehensive testing, including DOP/PAO filter integrity, airflow analysis, and ISO 14644-compliant particle testing. We deliver regulatory-compliant solutions to maintain sterility and environmental control in pharmaceutical facilities.
Why is it Critical?
HVAC validation ensures environmental control, sterility, and regulatory compliance in cleanrooms, minimizing contamination risks for sterile and non-sterile products.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led validation solutions, providing regulator-ready documentation to support compliance and audit-readiness.
Our Expert HVAC Validation Approach
At Indivirtus Healthcare Services, our HVAC Validation services are led by certified validation experts with global regulatory expertise. We perform comprehensive testing, including HEPA filter integrity (DOP/PAO), airflow pattern visualization, differential pressure analysis, and non-viable particulate testing to ensure cleanroom performance.
Our approach ensures regulator-ready validation, aligning with ISO 14644-1:2015, EU GMP Annex 1, US FDA cGMP, and ISPE Guidelines for reliable and compliant HVAC systems.
HVAC Validation Deliverables
HEPA Filter Integrity Test Reports (DOP/PAO): Verification of filter performance.
Airflow Pattern Visualization Reports: Detailed analysis of airflow dynamics.
ISO 14644 Cleanroom Classification Certificates: Certification of cleanroom compliance.
Temperature, Humidity, and Particle Count Logs: Comprehensive environmental data.
Regulatory Compliance & Global Standards
Our HVAC Validation services align with stringent global standards, ensuring your cleanrooms are audit-ready and compliant with international regulatory expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance sterility and regulatory confidence.
- ISO 14644-1:2015: Standards for cleanroom classification and testing.
- EU GMP Annex 1: European guidelines for sterile manufacturing.
- US FDA cGMP: U.S. regulations for current good manufacturing practices.
- ISPE Guidelines: Industry best practices for cleanroom and HVAC validation.
Applications & Use Cases
Our HVAC Validation services are essential for pharmaceutical companies ensuring cleanroom compliance and sterility. Ideal for production and packaging zones, our solutions support global markets. Key use cases include validating new cleanroom installations, ensuring compliance for sterile product manufacturing, and preparing for FDA/EMA audits.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led HVAC validation solutions backed by certified professionals with global experience. Our services ensure regulator-ready outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your facility with compliant, robust HVAC systems, driving regulatory success and product safety.
Frequently Asked Questions
Frequently Asked Questions
What is HVAC validation in pharmaceutical cleanrooms?
HVAC validation ensures that heating, ventilation, and air conditioning systems perform within defined environmental parameters, maintaining cleanroom integrity and regulatory compliance.
Why is DOP/PAO filter testing important?
DOP/PAO filter testing verifies the integrity of HEPA filters, which are critical in trapping contaminants and ensuring sterile manufacturing conditions.
Which guidelines are followed during HVAC validation?
We follow ISO 14644, EU GMP Annex 1, US FDA cGMP, and ISPE guidelines to ensure global compliance in HVAC validation services.
How often should HVAC systems be revalidated?
HVAC systems should be validated annually or whenever there are major changes, repairs, or deviations affecting cleanroom performance.
Can you assist with HVAC qualification for new facilities?
Yes, Indivirtus provides end-to-end HVAC qualification support during facility commissioning, including testing, documentation, and regulatory alignment.
What do HVAC Validation services include?
Our services include DOP/PAO filter testing, airflow pattern visualization, non-viable particulate testing, and ISO 14644 cleanroom classification.
Who benefits from HVAC Validation services?
Pharmaceutical companies operating cleanrooms for sterile or non-sterile production benefit from our tailored validation solutions.
How do these services ensure regulatory compliance?
Our services align with ISO 14644-1:2015, EU GMP Annex 1, US FDA cGMP, and ISPE Guidelines, ensuring global compliance.
What deliverables are provided with the service?
Clients receive HEPA filter test reports, airflow visualization reports, ISO 14644 certificates, and environmental data logs.
Can the HVAC validation services be customized for our needs?
Yes, our services are tailored to your specific cleanroom systems and regulatory requirements, ensuring compliant solutions.
How do the services support audit-readiness?
We provide comprehensive, regulator-compliant reports and certifications to ensure seamless audits and cleanroom compliance.