Our company provides Compressed Air and Gas system validation services to guarantee compliance with regulations and suitability for the intended use.
Compressed Air and Gas System Validation
At Qvalitek, we specialize in the validation of compressed air and gas systems, ensuring compliance with stringent regulatory requirements and suitability for their intended use. This service is critical in high-risk sectors like pharmaceuticals and food manufacturing.
Why Validate Your Compressed Air and Gas Systems? Validation is essential to confirm that your systems meet the necessary purity and safety standards. This process is crucial for maintaining product integrity and compliance with regulatory standards.
Our Validation Services Include:
- Comprehensive Testing: Our validation protocols include rigorous tests for particles, water, oil, and microorganisms to ensure compliance with ISO 8573 purity limits and analytical methodologies.
- Risk Assessment: We conduct thorough risk assessments tailored to your system requirements, identifying potential contamination sources and mitigating risks.
- Detailed Documentation: We provide meticulous documentation of the validation process, including specification delineation, precise timelines, and comprehensive records.
- Expert Training: Our team offers in-depth training to ensure your personnel are well-versed in maintaining and monitoring system integrity.
Validation Process:
- Specification Definition: Establishing clear specifications based on regulatory requirements and industry standards.
- Implementation: Executing validation protocols, including particle counting and microbiological analysis.
- Monitoring and Reporting: Continuous monitoring using advanced techniques and detailed reporting to ensure ongoing compliance.
By adhering to ISO 8573 standards, we ensure that your compressed air and gas systems operate at peak efficiency and safety. Our methods include microbiological and particle counting analyses, on-site water vapor testing, and comprehensive oil testing using Draeger tubes and other advanced technologies.
Ensuring Gas Purity: The purity of gases like nitrogen and oxygen is vital for optimal product quality. Our validation services guarantee that these gases meet the highest purity standards, safeguarding your production processes.