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.

Annual Requalification Protocol

The goal of this protocol is to determine whether or not the vaporized hydrogen peroxide system is still able to biodecontaminate the exposed, internal surfaces of the isolator and the exposed, external surfaces of items placed within the isolator. This protocol establishes documented evidence that the isolator's vaporized hydrogen peroxide system can still perform effectively based on the defined process methods and specifications.

To view this protocol's example Table of Contents, click the link below:

TABLE OF CONTENTS

The annual requalification effort is quite a bit more complicated than a periodic verification of the decontamiation system's performance. To learn why my clients continue to hire me for their annual requalification needs year after year click on the link below.

CLICK HERE

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

To request a quote, click here.

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Last Update: 11-Jan-2023