Pre-Validation Assistance

• Customer Needs, Expectations, and Economic Assessment
• Customer Education
• Project Definition and Scope Determination
• Request for Quotation Development
• Proposal Evaluations and Vendor Selection
• Project Communication Meetings and Vendor Education
• Proposal Refinement and Vendor Responsibility Determination
• Validation Master Planning and Timeline for Implementation
• System Design and Assistance
• Prototype Fabrication Assistance and Ergonomic Assessment
• Design Review and Refinement

Factory Acceptance Testing Assistance

Performing a Factory Acceptance Test (FAT) can be a critical stage in an isolator project. Identifying deficiencies prior to shipment makes things a lot easier for everyone involved. Rick Nieskes of Ardien Consulting Services has the proven experience and foresight to anticipate complications before they become serious problems.

On-Site Validation Protocol Execution

Any or all protocols associated with isolator validation will be executed on-site by Rick Nieskes of Ardien Consulting Services. No part of these services will be sub-contracted to a less experienced validation technician.

For further information on the protocols associated with isolator valdiation, CLICK HERE.

System Audit and Review

Rick Nieskes of Ardien Consulting Services can review your isolator system and the completed validation (even if it was performed by another validation firm) and provide a detailed report on deficiencies.

Get your isolator in compliance before you run into an issue with a regulatory agency!

Isolator Interior Revitalization Process

The service is basically an interior revitalization that involves polishing and passivation with a proprietary non-toxic solution. If the interior of your isolator does not look uniform in color or has areas of discoloration, it may be time to revitalize the isolator's interior. As the isolator ages and is exposed to repeated hydrogen peroxide decontamination cycles, the stainless steel chamber surfaces may experience signs of discoloration, surface rouging (a form of corrosion found on stainless steel) or other surface contamination that just doesn't seem to come off using traditional cleaning methods. Left uncorrected, this surface contamination can result in adequate decontamination because hydrogen peroxide gas can only inactive viable bioburden on clean surfaces.

Upon completion of all this work, you will receive a detailed report for compliance.

Staff Development (On-Site Teaching and Education Program)

Rick Nieskes of Ardien Consulting Services can provide on-site, hands-on, teaching and education related to the aspects of isolator valiation and isolator compliance, custom-built to suit your individual needs.