Ardien Consulting Services

Your Partner in Isolator Validation

Founded in 1994 by Rick Nieskes, Ardien Consulting Services provides customized isolator validation to the pharmaceutical industry.  The firm has successfully validated over 100 isolators for production, sterility testing, and containment based applications for over 40 different pharmaceutical companies throughout the world.

Welcome to the website of Ardien Consulting Services - Your Partner in Isolator Validation for over 28 years!

Rick Nieskes Working Within a Half-Suit - Year 1996

Rick Nieskes Working Within a Half-Suit - Year 1996

Founded in 1994 by Rick Nieskes, Ardien Consulting Services provides customized isolator validation to the pharmaceutical industry.  

Ardien Consulting Services has successfully validated over 100 isolators for Aseptic Manufacturing, Quality Control Laboratory Sterility Testing and Containment applications from over 40 different pharmaceutical companies throughout the world.  

See my  CLIENT LIST for further information.

Here is what a few of my clients have recently said about the quality, thoroughness and cost associated with my services.

For more complete information, select the TESTIMONIALS navigation tab.

You are the most-knowledgeable person this company has ever contracted concerning this subject. I just wanted to tell you that I have recently been reviewing a validation protocol developed for me by an outside company (for a different project). The level of quality between your validation protocols and those developed by this company are enormous. I justed wanted to thank you for the extermely thorough and comprehensive job that you have done so far. You are well-worth the cost!
— Bryan Petrofsky, Mallinckrodt Pharmaceuticals
I can honestly say that you are one of the best vendors I’ve worked with in 20 years. You don’t keep secrets, you try to teach, and you’ve shown me that isolators are not just boxes with fans, and there really are no shortcuts. If you understand everything about them, they work properly, and when you don’t understand everything, their operation and sanitization continues to be a mystery. Your meticulous approach is one reason why our isolators continue to operate without strange failures that plague so many others.
— name withheld for confidentiality reasons
Thanks for helping us meet our timeline Rick. As always, it was a pleasure working with you. I tell all the clients and auditors that come through that our system was validated by the industry leading isolator consultant.
— Bo Henry, Cook Pharmica LLC.

I am an independent contractor experienced and proven in validating isolators from numerous different manufacturers.  I do not endorse any one particular company or piece of equipment, but work with my clients and the isolator manufacturers to help select equipment and validation services to best suit my client's needs and expectations.

My main specialty is the Quality Control Laboratory Sterility Testing application and I have successfully used that knowledge as a spring-board to work with Aseptic Manufacturing and Containment applications. 

Because of the number of years I have been dedicated to the issues surrounding isolation technology, I now have the ability to foresee most problems before they become a reality.  I use my hands-on experiences to assist my clients with specifying engineering modifications to equipment during the design phase of a project and incorporate numerous unique methods and techniques within their Standard Operating Procedures.

Ardien Consulting Services D-Value Apparatus in Use During a Decontamination Cycle

Ardien Consulting Services D-Value Apparatus in Use During a Decontamination Cycle

What is a conflict of interest in the context of isolator validation?  A conflict of interest can be defined as a relationship that might impair an employee's ability to make objective decisions relating to the validation of an isolator.  Is there a conflict of interest when an employee of an isolator manufacturer attempts to impartially validate their own equipment?  You decide.

When you hire me you eliminate any potential claim of a conflict of interest by regulatory agencies because I am a neutral, third-party expert.  I do not have a financial stake in any one particular company or division within my company, therefore I am able to provide non-biased services with full emphasis placed squarely on my client's interests.  My services are fully customized, not a basic standard template that most companies provide.  My responses to your inquires are prompt and typically within the very same day you contact me;  something I feel very strongly about.

Thank you for your attention, and let me know if I can be of service to you!

Operator Working within a Half-Suit

Operator Working within a Half-Suit

Questions?  Email me or call me at 262-853-9748.

To request a quote, click here.

© 2023 Ardien Consulting Services, LLC

Last Update: 11-Jan-2023