Cleanroom Trainings
GxP Cellators – Cleanroom Training & Compliance Solutions
At GxP Cellators, we provide specialized Cleanroom Training programs designed for pharmaceutical, biotechnology, medical device, and advanced therapy facilities. Our customizable programs align with global standards, including International Organization for Standardization (ISO 14644), the European Medicines Agency (EU GMP framework), and the U.S. Food and Drug Administration (US FDA).
We deliver training onsite or virtually, tailored to your facility’s cleanroom classification, product type, process flow, and contamination control strategy. This approach ensures practical, inspection-ready implementation.
Core Training & Capability Development Areas
- Cleanroom Operations & Protocols Cleanroom classifications and ISO standards Environmental monitoring principles Contamination control strategies Cleaning, disinfection & material flow controls
- Cleanroom Qualification & Validation Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Airflow visualization (smoke studies)
HEPA filter integrity testing Requalification requirements & lifecycle management - Cleanroom Design & Documentation Principles Facility layout and personnel/material flow optimization HVAC systems & pressure differentials SOP development & documentation controls
Risk-based contamination prevention design - Cleanroom Behavior & Personnel Practices Gowning qualification & aseptic techniques Personnel hygiene and microbiological control
Beyond Training – Enabling Sustainable Cleanroom Compliance GxP Cellators combines regulatory expertise with practical facility operations. We help organizations build and maintain GMP-compliant cleanroom environments through:
- Cleanroom gap assessments & compliance audits
- Support during facility design & commissioning
- Qualification protocol development & review
- Environmental monitoring program setup
- Ongoing mentoring for contamination control excellence
Whether you are commissioning a new cleanroom or optimizing an existing environment, GxP Cellators supports operational excellence in line with global regulatory standards.
GxP Cellators – Advancing Controlled Environments. Ensuring Compliant Performance.
Reach Out to Us!
For more details or to discuss your project requirements, please reach out to us. Your query will be handled with complete confidentiality, and we’ll ensure a prompt response.
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