Executive Q&A: AST Revolutionizes Aseptic Fill/Finish

With over 50 years of experience designing, manufacturing, and servicing innovative, high-quality, and highly automated processing equipment, AST, Inc. has revolutionized the aseptic fill/finish industry.

In 2006, AST leveraged its deep experience and close customer relationships to launch the groundbreaking ASEPTiCell^®. Utilizing robotics and advanced automation, the ASEPTiCell^® was the industry’s first aseptic multi-format fill/finish machine capable of processing ready-to-use nested vials, cartridges, and syringes on the same line.

Today, AST offers customers a comprehensive range of products and services to support drug product development, clinical trials, and commercial fill/finish requirements.

Next-Generation Isolator Technology

AST’s isolator is a next-generation modular fill-finish isolator designed in collaboration with Germfree. As a 100% American-made and serviced product, the isolator will be available at significantly reduced lead times with a resilient, adaptable manufacturing philosophy and streamlined, localized supply chain.

Key features of the innovative isolator include:

• User-friendly, side-hinged doors that are more accessible and don’t block laminar airflow
• Sleek, modern aesthetic design with no gapping or incongruities
• Compact, flexible footprint able to fit rooms with 10 ft ceilings
• Prioritized visibility and accessibility
• Optimized airflow systems
• Innovative VPHP solution using CURIS System’s Pulse™ technology for 1-hour decontamination cycles
• Ergonomic, fortified stainless steel glove ports for easy glove installation
• Comprehensive sensor coverage, integrated PAO generator, and state-of-the-art HMI
• Semi-automated HEPA filter changeout by a single operator and simplified air distribution membrane installation.

Speed to Market

“We are very much a modular company in terms of design,” said Josh Russell, AST’s VP of Sales & Marketing. “Speed to market is super critical, especially for these critical therapies people are looking to roll out.”

He explained AST’s modular approach: “We configure standard pre-designed modules, like grabbing the right tools for the job from a toolbox. If we don’t have an existing tool, then there is a lead time impact. But generally, we capture 90% of requirements with our existing solutions which allows very rapid configuration and delivery.”

Innovative Decontamination System

AST’s isolator integrates CURIS System’s 7000ei 7% hydrogen peroxide vapor decontamination system. Compared to typical 35-40% hydrogen peroxide systems, the 7% solution provides:

• Equivalent bio-decontamination efficacy
• 60-minute cycle times (including aeration) instead of hours
• Minimal material degradation and residual off-gassing
• Inherent operator safety even in the event of a breach

“Lower concentration means a non-hazardous environment which equals safer personnel,” remarked Russell. “At 7%, if there is any leak it is automatically at safe 1 ppm operator exposure levels.”

The rapid cycle times are enabled by CURIS’ Pulse technology which injects and recirculates the vapor to maintain the precise concentration level.

Future Innovation

Looking ahead, Russell sees opportunities for advancements in tech transfer strategies, cell and gene therapy manufacturing, and further contamination control enhancements aligned with Annex 1 guidance.

"We’re showcasing many of these innovative features on this filling line and when combined with the AST isolator, this offers a fully integrated, turn-key solution. It’s an exciting step forward as we continue advancing contamination control strategies."

With its pioneering technology and forward-looking vision, AST is well-positioned to continue leading aseptic fill/finish into the future.

Author Details 

Josh Russell, VP, Sales & Marketing- AST, Inc.

Publication Details 

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