We provide comprehensive validation steps for hot cells, focusing on protecting both the product and the operator.
Ensuring the safety and efficacy of radiopharmaceuticals, our validation services adhere to GMP (Good Manufacturing Practices) requirements.
Validation Process
1. Design Qualification (DQ)
- Developing detailed design specifications ensuring compliance with GMP standards.
2. Installation Qualification (IQ)
- Verifying installation of equipment according to manufacturer’s specifications and regulatory guidelines.
3. Operational Qualification (OQ)
- Testing equipment operation under anticipated conditions to ensure performance consistency.
Key Elements
Air Cleanliness
- Compliance with WHO and FDA classifications for particle diameter size and concentration limits.
- Implementation of microbiological monitoring programs covering air, surfaces, and personnel.
Isolator Integrity
- Ensuring the isolators are leak-proof and constructed with puncture-resistant materials.
- Routine testing of isolators and glove/sleeve systems for air quality and sanitization.
Environmental Controls
- Maintaining negative pressure gradients to prevent contamination.
- Monitoring air flow, filter integrity, and particle counts both at rest and during operation.
Compliance and Monitoring
Regulatory Adherence
- Meeting international standards from bodies such as the FDA, EudraLex, and ISO.
- Establishing a robust validation master plan in collaboration with the manufacturer’s Quality Assurance office.
Routine Testing
- Continuous validation including HEPA filter tests, air velocity measurements, and leak tests to ensure ongoing compliance.
Conclusion
Our validation services for radiopharmaceutical hot cells are designed to ensure compliance with GMP requirements, safeguarding both product quality and operator safety. Through meticulous testing and adherence to international standards, we help maintain the highest levels of operational integrity in radiopharmaceutical manufacturing environments.
Contact Us: Reach out to Qvalitek to learn more.