Both Cleanroom and Non Cleanroom Applications
1. Developed specifically for your particular requirements, that is menu driven, which encompasses the profiling and documentation of the overall operational performance of your existing space in question, such tests may include, but is not limited to:
For Cleanroom Applications: HEPA Filter Integrity Testing (In Place & Bench Testing) - Temperature/Relative Humidity Profiling - Air Velocity Room Profiling, Air Flow Visualization (smoke) Studies - Room Pressurization - Airborne Particle Counts.
For Non- Cleanroom Applications: Airborne Particle Count Investigations for non cleanroom applications such as Paint Spray Booths and Glass Mfg, up to 100 Microns.
2. Contaminant Control Investigations Pertaining to Production Defect/Yield Enhancements tailored to your specific requirements.
- Measure particle contamination via viable and non viable particle monitoring.
- Perform analysis of particle contamination through SEM, ESCA, Fourier Transform Analysis and additional methods to determine source of contamination.
- Design and Implement contamination control corrective actions and operational procedures that are specifically designed to address the unique needs and requirements of the process found in question.
4. Review of your exiting Personnel Protocol, Housekeeping and Custodial Procedures.
5. Review of existing Operational, Maintenance, Housekeeping and Custodial SOP' manuals & Protocol documents.
6. Review of existing Airflow Management Practices.
7. Pre audit consulting for ISO 13485.6.4.b & c pertaining to cleanrooms & controlled environments.