HVAC & Cleanroom Validation
HVAC & Cleanroom Validation Services by Vashishta Engineering Services
Vashishta Engineering Services is a leading specialist provider of validation services for pharmaceutical, healthcare, and life sciences industries. With over 20 years of industrial experience, we offer comprehensive HVAC and cleanroom validation services nationally and internationally, ensuring compliance with global regulatory standards.
Why HVAC & Cleanroom Validation?
Cleanroom and HVAC validation ensures that your controlled environment operates as intended, safeguarding product quality and patient safety. Key reasons for validation include:
Verifying facility design aligns with its intended purpose.
Ensuring compliance with User Requirement Specifications (URS).
Meeting stringent regulatory requirements (e.g., ISO, EU GMP, WHO).
Confirming that facilities, equipment, and environments function cohesively to meet defined standards.
Our Compliance Framework
We perform HVAC and cleanroom validation in accordance with:
ISO 14644-1,2,3: Cleanroom classification and testing.
EU GMP/EC GMP: Good Manufacturing Practices guidelines.
WHO-TRS-937, WHO-TRS-961: World Health Organization technical guidelines.
Schedule M: Indian regulatory requirements for pharmaceuticals.
Cleanroom Certification & Monitoring
Certification
We validate cleanrooms to the required class of cleanliness as defined in ISO 14644-1. The level of cleanliness is determined by your specific operational and regulatory needs.
Monitoring & Control
Post-certification, continuous monitoring is essential to maintain compliance. We recommend statistical process control (SPC) to track cleanroom parameters, as outlined in ISO 14644-2.