Our company provides isolator qualification services to guarantee compliance with regulations and suitability for the intended use.
Isolator Qualification Services
At Qvalitek, we specialize in comprehensive isolator qualification services to ensure your equipment meets regulatory standards and is fit for its intended use.
Our Services Include:
- Design Review: We assess your isolator’s design to ensure compliance with regulations, focusing on critical components like airlock systems, filters, and pressure differentials.
- Performance Testing: Our team conducts thorough testing to verify that your isolator operates as intended, evaluating airflow, pressure differentials, and leak tightness.
- Microbial Challenge Testing: We validate sterilization and decontamination processes using biological indicators to simulate worst-case scenarios and ensure effective microbial elimination.
- Recovery Testing: This involves testing the isolator’s ability to return to its desired cleanliness level after disturbances, measuring recovery time for particle concentration.
- Report and Documentation: We provide detailed reports of our findings, along with recommendations for corrective actions and comprehensive documentation to demonstrate regulatory compliance.
Why Choose Qvalitek?
- Expertise: Our team has extensive experience in isolator qualification, ensuring high-quality and reliable services.
- Compliance: We ensure your isolators meet all regulatory requirements.
- Customized Solutions: We work closely with you to tailor our services to your specific needs and requirements.
Contact Us We are committed to delivering high-quality services and ensuring client satisfaction. Reach out to us for more information or to schedule your isolator qualification.