AST Atmos™
Grade A Protection Meets Turnkey Innovation
- Compact, flexible design
- State-of-the-art automation and user-friendly features
- Industry-leading decontamination cycle times
- American-made and serviced
- Exclusively integrates with our fill-finish systems for a 100 % turnkey AST solution
A technically superior, cGMP-compliant product, the AST Atmos Isolator features a groundbreaking user-friendly design, enhanced automation and efficiency, robust sterility assurance, and a disruptive VPHP solution providing industry-leading bio-decontamination cycle times. This American-made isolator solution, designed in collaboration with Germfree, is supported by a streamlined, responsive, and localized supply chain, and offers a new dimension of flexibility for fill-finish manufacturing.
The Next Level of Turnkey
With the addition of the Atmos isolator, we now offer 100-percent integrated, American-made fill-finish lines fully designed, supplied, and serviced by AST. When outfitted with Atmos isolator technology, our fill-finish systems offer complete turnkey aseptic processing solutions for the full scope of drug development needs.
Our turnkey solutions are supported by a streamlined and localized model of supply and service that maximizes production uptime while offering your operation new dimensions of agility, durability, and responsiveness. With AST, American ingenuity and quality are more accessible than ever.
The Full-Service Advantage:
Built for a cGMP Future: Annex 1 and Beyond
Atmos – Next-Generation Barrier Technology
As the recent rise in the use of isolator technology has shown, regulation follows innovation. AST is committed to providing forward-looking solutions that enable customers to thrive well into the future. We have a proven track record of innovative leadership in optimizing the fill-finish process. Our technical team has been at the forefront of some of the most significant advancements in sterility strategies, operator safety, process improvements, and product stewardship over the past decade, and that level of expertise is brought to every project. Our products are high-performance, regulatorily advanced systems designed with an eye towards the future of the life science industry. If the remedy for uncertainty is flexibility, then customers will always be prepared for the next opportunity with AST’s integrated solutions.
Industry-Leading Biodecontamination Technology
AST has partnered with CURIS System to integrate their 7000ei decontamination system with our Atmos™ isolator. With complete cycle times in less than 60 minutes (including aeration) and a low concentration 7% hydrogen peroxide application, AST isolators offer fast cycle times with superior material compatibility and virtually no outgassing. This FDA and Annex 1-compliant solution sets a new benchmark in contamination control and sterility assurance.
Features:
- An innovative vapor-only hydrogen peroxide decontamination system
- Utilizes 7% Vapor Phase Hydrogen Peroxide (VPHP) with CURIS’s patented Pulse™ technology for low-volume, max-efficacy application
- 1hr cycle times, including aeration
- The only low-concentration solution that’s Annex 1, EPA, and FDA compliant
- Market-leading sustainability: A low volume, less corrosive concentration means extended life of your equipment and expanded material and sensitive instrument compatibility
- Fully automated, repeatable technology for proven 6-log sporicidal efficacy
Optimized Air Handling – Designed to Maintain First Air and Unidirectional Airflow
- Open chamber design in every module for minimal airflow disturbance
- Unidirectional airflow at a velocity of 0.45m/s +/-20%
- HEPA filter coverage of at least 70 percent across all modules
- Precise placement between HEPA filters and air distribution membrane; Isolator design eliminates stagnant airflow pockets and avoids structural airflow obstructions
- Intake and exhaust plenums are completely separate for efficient air exchanges, and completely contained in the tech housing; Programmable for 100% exhaust or recirculation
- An integrated PAO generator for efficient, simplified filter integrity testing
- A closed loop, positive pressure system, including automated decontamination measures that introduce no outside air into the isolator
- Comprehensive sensor suite that monitors conditions of the isolator at all times, including precise seal leak detection that alerts the operator in real time
Designed with Operators in Mind
Fill-finish operators face a unique set of challenges and considerations when approaching any pharmaceutical manufacturing operation, including choice of configuration and technologies, ergonomics, cleaning and contamination control protocols, training, and the overall complexity of an aseptic processing system.
The Atmos isolator answers common pain points encountered across the industry in a way that directly optimizes and de-risks isolator operations and protocols.
Simple in design and robust in function, this isolator technology is the result of over a decade of delivering solutions for sterile parenteral production and gathering operator feedback on day-to-day challenges and areas where isolator applications could be improved.
Features:
- Aesthetic, cleanable exterior with no gapping or incongruity in the frame, including a compact design for tech housing and motor drives
- Adjustable ducting for smaller rooms or rooms with impenetrable ceilings. Able to fit in rooms with ceilings as low as 10 feet.
- Accessible side-hinge doors that are easy to open and don’t block laminar air flow
- Seamless, open interior with ample room for the operator to navigate that avoids hard-to-reach/clean areas
- Improved visibility with larger windows and narrower sectional divides, providing more room for the operator
- Semi-automated HEPA filter changeout; removal and installation of all filters can be executed by a trained operator in 15 minutes
- Simplified, ergonomically improved Air Diffuser Membrane changeout
AST’s Wireless Glove Tester – Annex 1 Compliance at Your Fingertips
The AST Shield™GIT is an advanced, fully integrated glove testing system prioritizing operator safety and product integrity. As part of an active contamination control strategy, this glove testing system provides operators with the tools necessary to validate quickly and maintain complete records, data, and peace of mind over the life of your gloves. Features include:
- 4k high-definition, touchscreen display
- Fully integrates glove testing system data with batch reports, accessible through ASTView®
- Interlocks with start and end of batch operations to maintain sterility protocols
- UL and CE certification ready
- A comprehensive solution with docking cart, chargers, and self-verification system for four testers
