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.

Products

Filtrate Drain System

As part of routine membrane filtration sterility testing, the filtrate (solution that flows through the membrane filtration units) passes from the isolator’s internal environment and into a Collection Vessel stationed in the room. To facilitate this process, a Filtrate Drain System or FDS has been uniquely designed and developed by Ardien Consulting Services.

To view the operations manual for the FDS, click here.

For pricing, CONTACT Ardien Consulting Services.

Ardien Consulting Services Filtrate Drain System

Ardien Consulting Services Filtrate Drain System

Glove Leak Test Apparatus

The Glove Leak Test Apparatus (GLTA) is an electropolished and passivated 316L stainless steel device used to leak test isolator gloves.

The GLTA is for testing gloves removed from the glove sleeves. Since the glove itself is the most likely area for leaks (and the most critical), the method for detecting leaks in gloves must be highly sensitive. The GLTA identifies leaks too small to detect by even the most sophisticated pressure leak testing systems and is capable of detecting a hole approximately 10 micrometers (0.01 mm) in diameter. Unlike other leak testing devices, the GLTA actually identifies the number and location of leaks. As it relates to the glove sleeves, these are typically tested via ammonia (most common) or a separate pressure-constant or pressure-decay leak testing device.

The GLTA package includes complete instructions (for implementation into a Standard Operating Procedure), pressure gauge, quick-disconnect fittings, silicone tubing and silicone O-rings.

To view the operations manual for the GLTA, click here.

For pricing, CONTACT Ardien Consulting Services.

Ardien Consulting Services Glove Leak Test Apparatus

Ardien Consulting Services Glove Leak Test Apparatus

Non-Viable Particulate Air Monitoring Adapters for SKAN Isolators

As part of routine compendial sterility testing, Non-Viable Particulate (NVP) air sampling is often performed.

The standard connection from SKAN is open directly to the room; there is no inline protection from the room and the Grade A internal isolator environment. These NVP adapters provide a sanitary connection to the NVP port on the isolator and allow it to be capped off when not in use.

To view the operations manual for the NVP Adapters, click here.

For pricing, CONTACT Ardien Consulting Services.

Ardien Consulting Services NVP Adapters for SKAN Isolators

Ardien Consulting Services NVP Adapters for SKAN Isolators

Customized Product Racks

These electropolished and passivated 316L stainless steel racks are designed to minimize surface-to-surface contact locations in order to maximize exposure of the decontamination agent.

For pricing, CONTACT Ardien Consulting Services.

Ardien Consulting Services Customized Product Racks for Vials and Syringes

Ardien Consulting Services Customized Product Racks for Vials and Syringes

Ardien Consulting Services Customized Product Racks for 125 mL Bottles

Ardien Consulting Services Customized Product Racks for 125 mL Bottles

Thermocouple Port with Sanitary Fitting

This heavy-duty 316L stainless steel port allows for the introduction of approximately 40 thermocouples into an isolator or similar enclosure equipped with a sanitary fitting. Customized removable silicone gaskets seal the thermocouples to prevent leakage.

For pricing, CONTACT Ardien Consulting Services.

Ardien Consulting Services Thermocouple Port with Sanitary Fitting

Ardien Consulting Services Thermocouple Port with Sanitary Fitting

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