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.

Publications

Looking for publications, references or guidelines related to isolation technology?  Over the years I have gathered quite a few documents that I would like to share with the community.  This Resource Center is designed to help our industry obtain technical information regarding isolation technology.

If you feel I have missed an important document, please CONTACT me.  I will then assess your request, determine if it is relevant, and then add to the list.

Check back periodically because I will be adding documentation as they become available to me.  Newly added documents will be inserted at the beginning of the list.

This list is NOT presented in alphabetical order, so please view the list in its entirety.

Click on the document you wish to view and/or print.  That's all!  Then click on your browser's back button to return to the Resource Center.

I sincerely hope you find this Resource Center a valuable place to obtain the information you require!

Date of Last Update:  28-Sep-2018.

"Evaluation of Novel Process Indicators (Enzymatic Indicators) for Rapid Monitoring of Hydrogen Peroxide Decontamination Processes", 2017.

"Appropriate Challenges for the Validation of Hydrogen Peroxide Vapour Sanitization Cycles", Jul 2016.

"Leak Rate Measurement for Pharmaceutical Isolators: Practical Guidance for Operators and Test Engineers", Jul 2012.

"Statistical Methods for Interpreting Multiple BI Results", Sep 2013.

"Biological Indicators for Hydrogen Peroxide Vapor Technology", 2013.

"Summary Overview of the Design and Use of Bioquell Chemical Indicators", 30 Nov 2012.

"Using Replicate BIs to Evaluate Biodecontamination Cycles in Isolators", Volume 9, Number 4.

"Proper Biological Indicator Placement During VHP Decontamination Cycles", Volume 9, Number 5.

"Parameters Effectiving Vapor Hydrogen Peroxide Biological Indicator Performance", Volume 9, Number 3.

"Assessment of Biological Indicators in the Validation of Isolator Decontamination with Hydrogen Peroxide", dated 23 February 2011.

"Computational Fluid Dynamics Modeling of Pharmaceutical Isolators with Experimental Verification of Airflow", dated July-August 2007.

"Comparing and Contrasting Barrier Isolator Decontamination Systems", dated November 2004.

"Current Good Validation Practice", dated November/December 2006.

"Development and Quantification of Hydrogen Peroxide Decontamination Cycles", dated July/August 2000.

"Efficacy of Vaporized Hydrogen Peroxide Against Exotic Animal Viruses", dated 30 July 1997.

"Tutorial on HEPA Filtration", dated March 2007.

"Expression of Isolator Leak Rate - Percentage Volume Change Per Hour, A Guide for Normal People", dated March 2004.

"Case Study: Isolator Sanitisation Cycle Development Validation and Revalidation", dated 2005.

"A New Approach to Vapor Hydrogen Peroxide Decontamination of Isolators and Cleanrooms", dated May/June 2006.

"Particle Monitoring in Pharmaceutical Cleanrooms".

"The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide", dated January/February 2007.

"Effect of Carrier Materials on the Resistance of Spores of Bacillus stearothermophilus to Gaseous Hydrogen Peroxide", dated January/February 2003.

"Suitability of Different Construction Materials for Use in Aseptic Processing Enviroments Decontaminated with Gaseous Hydrogen Peroxide", dated July-August 2007.

"Particle Measuring Systems, Airnet-510 XR Resilience to Vaporized Hydrogen Peroxide".

"Particle Measuring Systems, Frequently Asked Questions about Vaporized Hydrogen Peroxide", dated 2005.

"Validation Strategy for a Sterility Testing Isolator Project".

"Vaporized Hydrogen Peroxide-based Biodecontamination of a High-Containment Laboratory Under Negative Pressure", dated 2006.

"Hach Ultra, Met One Sensors Resistant to Vaporized Hydrogen Peroxide (VHP)".

"Room Decontamination with Hydrogen Peroxide Vapor".

"Case Study: The Selection and Evaluation of an Isolator System Required for Rapid Response Pharmaceutical Compounding".

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

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Last Update: 11-Jan-2023