Clean Room Validation Services
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Comprehensive Clean Room Validation for Uncompromising Quality
In critical manufacturing, research, and healthcare environments—where even microscopic contaminants can compromise product integrity, patient safety, or research outcomes—Clean Room Validation Services are far more than a regulatory requirement; they are the bedrock of quality assurance and operational integrity. At Dakshina Technologies, we deliver meticulous, fully compliant Clean Room Validation Services that ensure your controlled environments consistently meet and exceed stringent international standards, including ISO 14644, EU GMP Annex 1, and US FDA cGMP.
Based in Chennai and ISO 9001:2015 certified, Dakshina Technologies works with an NABL-accredited sister concern to provide full NABL-traceable certificates for your peace of mind. We serve clients across India, applying advanced technology and deep industry knowledge for end-to-end validation solutions. From pharmaceutical manufacturing and biotechnology to advanced healthcare and microelectronics, a properly validated cleanroom safeguards operations, minimizes risk, and ensures product efficacy and safety.
The Indispensable Role of Clean Room Validation
Clean Room Validation Services for Regulatory Compliance and Quality Assurance
Adhering to national and international guidelines—such as ISO 14644, EU GMP Annex 1, US FDA cGMP, WHO GMP, and Indian regulations—is mandatory for any industry operating in controlled environments. Clean Room Validation Services provide the documented evidence demanded by regulators during audits, preventing costly penalties, shutdowns, and reputational risks.
Beyond compliance, they are a core part of your quality assurance system, ensuring that products are manufactured in environments that guarantee purity, efficacy, and safety. This is vital for pharmaceuticals, medical devices, and food industries, reducing the risk of recalls and protecting consumer trust.
How Clean Room Validation Services Mitigate Risks and Improve Efficiency
Through rigorous testing and assessments, our Clean Room Validation Services help identify potential failure points or performance deviations. Early detection allows timely corrective action, minimizing risks such as batch rejections, cross-contamination, or environmental excursions that cause costly delays.
A well-validated cleanroom runs more predictably and efficiently—optimizing airflow, pressure differentials, and filtration to reduce energy costs and improve performance. Establishing a clear performance baseline also supports predictive maintenance, improving uptime and long-term facility management.
Our Methodology for Clean Room Validation
Systematic, Standard-Compliant Clean Room Validation Services
Key Tests Included in Our Clean Room Validation Services
- Airborne Particle Count Test (ISO 14644-1 Classification): Measures non-viable airborne particles to confirm ISO classification.
- Airflow Volume and Air Change Rate (ACR) Calculation: Verifies total air volume supplied and room air changes per hour.
- Differential Pressure Measurement: Confirms correct pressure cascades to prevent contamination between zones.
- HEPA/ULPA Filter Integrity Test (PAO/DOP Leak Test): Detects leaks or damage in critical filtration systems.
- Airflow Pattern Visualization (Smoke Study): Visually assesses airflow patterns to identify turbulent or stagnant areas.
- Temperature and Humidity Mapping: Ensures uniform environmental conditions to maintain product stability and prevent microbial growth.
- Recovery Test: Measures how quickly the cleanroom returns to required cleanliness after a contamination event.
- Microbial Monitoring (Air and Surface): Tests for viable microorganisms to confirm biological control.
- Sound and Light Intensity Tests: Verifies comfort and compliance with workplace standards.
Case Study: Delivering Clean Room Validation Services for a Pharmaceutical Manufacturer
Client Background
A leading pharmaceutical company in Hyderabad needed to commission a new ISO Class 7 cleanroom and re-qualify an existing ISO Class 5 aseptic suite to secure EU GMP and US FDA approvals for a critical new vaccine.
Challenge
They faced tight timelines and strict requirements for pressure cascades, unidirectional airflow, and HEPA filter integrity under audit conditions.
Our Solution
Dakshina Technologies delivered a comprehensive Clean Room Validation Service package through its ISO-certified team and NABL-accredited sister concern:
- Design Qualification (DQ): Verified design and HVAC drawings for ISO 14644 and EU GMP compliance.
- Installation Qualification (IQ): Checked HEPA filters, air handling units, ducting, and monitoring systems.
- Operational & Performance Qualification (OQ/PQ): Conducted full airborne particle counts, differential pressure mapping, HEPA leak testing, airflow visualization (smoke study), recovery tests, and microbial monitoring.
Results
The project was delivered on schedule with complete ISO, EU GMP, and US FDA-compliant documentation. The client secured approvals smoothly and launched production of the new vaccine without delays.
Frequently Asked Questions (FAQs)
1) What is the purpose of Clean Room Validation?
It provides documented proof, through systematic tests, that a cleanroom performs as designed and meets required cleanliness standards under both static and dynamic conditions.
2) How often should Clean Room Validation be done?
Typically, annually or semi-annually—depending on industry and process criticality—or after major modifications or maintenance.
3) Which standards apply to Clean Room Validation in India?
Primarily ISO 14644, EU GMP Annex 1, and US FDA cGMP, along with relevant local regulatory guidelines.
4) What’s the difference between static and dynamic testing?
Static testing measures cleanroom performance without personnel or production equipment. Dynamic testing evaluates performance under real operating conditions with staff and equipment running.
5) Why is a HEPA filter integrity test important?
It ensures no leaks or bypasses in the HEPA filters, which could compromise the cleanroom’s cleanliness and risk product contamination.
Ensure the integrity and compliance of your cleanrooms with Dakshina Technologies’ expert Clean Room Validation Services. Contact us today to schedule a consultation or request a quote. Let our team help you maintain the standards and precision required for safe, high-quality production and patient care.