Cleanroom Management Consulting Services
CleanTech Systems offers expert contamination control GAP Analysis audits for Pharmaceutical, Biotech , Medical Device, Semiconductor and Aerospace industries. Observations and recommendations for improvement are rooted in the International Standards (ISO)14644 Cleanrooms and Associated Controlled Environments series, and the Institute of Environmental Science and Technologies (IEST) Contamination Control (CC) Recommended Practices Standards.
GAP Analysis Includes:
1. Yield Loss Investigation:
- Identify the sources of contamination.
- Identify the routes of transmission.
- Assess the degree of threat from the sources and risk to products.
2. Building Assessment:
- Integrity of building envelope and barrier surfaces- ceilings, walls, floors.
- HEPA Filter testing protocol and filter integrity.
- Mold contamination assessment.
- Potential/probable paths of infiltration
3. Evaluation of HVAC System Design and Current System Procedures:
- Configuration and capacities of utilities.
- Pressurization and directional airflows.
- Humidification and dehumidification sequences.
4. Evaluation of Operational Systems for contamination control factors:
- Segregation
- Equipment/Material Entry & flows
- Material Handling
- Gown Room Management, Gowning, Behaviors
- Cleaning/Disinfection Program
- Pest Control Program
Implementation and continued management of our recommendations will have a significant positive effect in maintaining your cleanroom, and operations in best-in-class condition.
“Ian is a highly knowledgeable, effective and competent leader in managing the risk of cleanroom contamination.”
-Patti Gupta: Former – FDA Officer Former – Head of Worldwide Quality – Merck Corporation Former – Director Worldwide Quality – Genentech & Janssen Pharmaceutical