Vol. 1, Issue 3  ‣ July 2024

Table of Contents

Personnel are a significant source of contamination in aseptic manufacturing, and reducing human intervention in critical zones is essential to ensure the sterility of finished goods. Isolators and RABS (Restricted Access Barrier Systems) work to control contamination during pharmaceutical production. Because these systems are equipped with a variety of sophisticated protections and physical barriers, they protect the operator from harmful chemicals and safeguard the product from pathogens and other particulate contamination.

RABS include safety-locked doors, a rigid machine enclosure, and glove ports that allow users to place their hands inside the chamber and adjust the product without interrupting the conditions inside the workspace. While a closed RABS system is suitable for use with slightly toxic products, it lacks the leak-tight certification required for highly toxic product assembly.

While there are different types of isolators used for various applications within the pharmaceutical space, one common type is a containment isolator. This isolator focuses on protecting the operator and environment from hazardous materials, usually operating under negative pressure.

Another isolator commonly used in the aseptic manufacturing environment is an aseptic processing or sterile filling isolator. These devices focus on protecting the product from contamination, usually operating under positive pressure to maintain a sterile environment, making them indispensable tools for pharmaceutical manufacturers working with particularly high-risk products.

Both types of isolators are critical in their respective applications, ensuring safety and compliance with regulatory standards.

For a complete list of advantages and disadvantages of both systems, as well as detailed insights into their specific applications and benefits, continue reading here.

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TRIO.BAS™ RABS ISOLATOR Kit, 100 Liters per minute, Contact Plate, with 1 Satellite 

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Sterile Gloves Requirement: Sterile gloves must be worn over the gloves attached to the RABS sleeves. This minimizes the risk of contamination to the environment and the compounded sterile preparation (CSP).

Disposable Gloves Inside RABS Gloves: It is recommended to wear disposable gloves inside the gloves attached to the RABS sleeves. This practice helps maintain the cleanliness of the RABS gloves, which may collect sweat or other contaminants.

The TRIO.BAS™ RABS Isolator and MULTIFLEX for counting viable particles.

The TRIO.BAS™ RABS Isolator and MULTIFLEX are ideally designed for the Pharmaceutical cleanroom! Learn more: https://hardydiagnostics.com/triobas/

See our FREE and complete catalog of TRIO.BAS™ products for more information.

Joelle Brackeen

PHARMACEUTICAL PRODUCT MANAGER

Joelle Brackeen is the Pharmaceutical Product Manager at Hardy Diagnostics and has over a decade of experience in Marketing and Product Management. Before transitioning to the pharma sector, Joelle had the privilege of co-founding and helping to grow a business into a highly profitable, multinational enterprise. Her unique blend of entrepreneurial spirit and product management expertise contributes to her innovative approach and ability to drive successful products and strategic initiatives in the pharmaceutical industry. In her free time, she enjoys playing the piano and spending time at the beach.

Do you have a suggestion, comment, or question? Please contact Joelle here.

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