Introduction

2025 was another pivotal year of growth for AST and for the broader life sciences industry. As sterile drug product manufacturers continue to prioritize patient safety and supply continuity, demand is rising for automated, modular aseptic fill-finish equipment that supports faster scale-up, robust contamination control, and predictable compliance.
Building on a strong 2024, AST expanded its focus on standardized, modular aseptic systems; robust cGMP (current Good Manufacturing Practice) strategies; and end-to-end support for parenteral manufacturing—from clinical batches through commercial production. Across partnerships, technology releases, and engineering services, the emphasis remained on user outcomes: reduced deviation rates, smoother inspections, and more repeatable performance in isolator-based filling lines.
In practical terms, this year’s key pillars centered on aseptic isolators, cGMP compliance services, digital twin enablement, and hydrogen peroxide vapor decontamination—all aligned to modern expectations such as EU GMP Annex 1 contamination control strategy requirements.
Section TL;DR: 2025 focused on modular aseptic fill-finish systems plus training, decontamination, glove integrity testing, and digitalization to help manufacturers improve sterility assurance and operational performance.
Strategic Partnership with Marchesini Group
In December 2025, AST announced a strategic partnership with Marchesini Group, a global supplier of pharmaceutical packaging machinery and integrated lines. The intent is to reduce handoffs between upstream fill-finish and downstream packaging by coordinating automation, controls philosophy, and line integration activities—an area that often drives avoidable schedule risk during tech transfer and scale-up.
The partnership is designed to:
- Develop more integrated, end-to-end aseptic manufacturing and packaging solutions
- Expand global support coverage for multi-site deployments
- Create added value through aligned automation, documentation packages, and service models
- Accelerate innovation across the sterile drug product lifecycle
For manufacturers operating in multiple regulatory regions, integrated line strategies can also simplify validation planning, enable more consistent batch records, and support global inspection readiness. For regulatory framing, many organizations map these efforts to risk-based principles in ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
Section TL;DR: The Marchesini partnership targets better end-to-end line integration, reducing scale-up friction and supporting global quality-system expectations (ICH Q9/Q10).
Global Industry Presence and Event Highlights

To connect solutions to real manufacturing constraints, AST engaged with customers and industry bodies throughout 2025 at major events such as PDA Week, INTERPHEX, and CPHI. These venues are often where manufacturers benchmark approaches to Annex 1 implementation, isolator decontamination cycle design, and digital maturity initiatives that fall under ISPE Pharma 4.0 concepts.
Section TL;DR: AST used major industry events to pressure-test practical solutions for Annex 1 implementation, isolator operations, and Pharma 4.0-aligned digitalization.
INTERPHEX 2025: A Milestone Year for AST
INTERPHEX again served as a focal point for discussions around flexible, modular systems that can support both clinical and commercial production—especially for advanced therapy medicinal products (ATMPs) where batch sizes may be small, changeovers are frequent, and contamination control needs are stringent.
A key announcement was the launch of a new integrated, fully automatic GENiSYS C filling line developed with Ascend Advanced Therapies. Ascend plans to install the system at its Alachua, Florida facility to add automated fill-finish capacity for advanced therapeutics and injectable products, reinforcing broader industry movement away from manual filling and toward isolator-based filling lines for sterility assurance.
INTERPHEX 2025 also coincided with AST’s 60th anniversary, and AST was recognized as the 2025 Efficiency Champion for its digital twin solution—an acknowledgment tied to measurable project outcomes such as shorter factory acceptance testing (FAT, Factory Acceptance Testing) loops, fewer commissioning surprises, and reduced cycle-time variability once in production.
Section TL;DR: INTERPHEX 2025 highlighted GENiSYS C adoption for advanced therapies and reinforced digital twin value in reducing FAT/commissioning risk and improving operational efficiency.
AST Team Growth and Leadership Expansion

As sterile manufacturing projects become more interdisciplinary (automation, microbiology, CQV, data integrity, and operations), AST expanded leadership and technical roles in 2025 to support end-to-end delivery.
- Jacob Stephen joined as Chief Operating Officer (COO), bringing experience in operations and large-scale life sciences projects.
- Charisse Curtis was formally introduced as Chief Commercial Officer (CCO), reinforcing a customer-focused approach.
- Jason Rossi joined as Principal CQV Engineer (Commissioning, Qualification, and Validation), strengthening execution of regulated start-ups.
AST also added engineering, operations, customer care, and business development resources to improve responsiveness during design, build, SAT (Site Acceptance Testing), PQ (Performance Qualification), and routine production support.
Section TL;DR: Expanded CQV and operations leadership is aimed at smoother start-ups, stronger documentation, and better support through SAT/PQ and routine operations.
Product and Service Advancements
Following the year’s partnership and event activity, AST’s core 2025 advancements focused on practical tools manufacturers can apply across the aseptic lifecycle—training to reduce human-factor risk, decontamination to reduce downtime, glove integrity to reduce interventions and deviations, and digital twins to reduce project and operational variability.
Section TL;DR: 2025 product/service releases targeted the highest-leverage drivers of sterility assurance and uptime: people (training), process (decon), barriers (gloves), and data (digital twin).
AST Academy: Comprehensive cGMP and CQV Training

Across parenteral manufacturing, regulators increasingly expect organizations to demonstrate not just compliant equipment, but competent people and a defensible contamination control strategy. This is reinforced by EU GMP Annex 1 expectations (including CCS—Contamination Control Strategy) and complementary guidance such as the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing.
In 2025, AST introduced AST Academy, a cGMP-focused training program designed for professionals working with aseptic isolators and isolator-based filling lines. The curriculum is oriented toward “work you actually do” during start-up and routine operations, including:
- cGMP fundamentals for sterile drug product manufacturing (roles, data integrity basics, documentation discipline)
- Aseptic processing principles, isolator fundamentals, and Annex 1 contamination control strategy alignment
- CQV deliverables and execution (URS, risk assessments, FAT/SAT, IQ/OQ/PQ; where IQ/OQ/PQ are Installation/Operational/Performance Qualification)
- Risk-based approaches using concepts consistent with ICH Q9 (e.g., failure modes, mitigation planning, and ongoing review)
Implementation considerations (practical):
- Infrastructure: define role-based training paths (operator vs. maintenance vs. QA) and ensure learning records integrate with your LMS (learning management system) or training matrix.
- Validation/change control: map training to qualification phases (e.g., complete baseline operator training before PQ media fills) and document effectiveness checks (assessments, supervised runs) for inspection readiness.
Anonymized scenario: A clinical-stage biotech transitioning from manual filling to a modular isolator-based filling line used structured CQV training to standardize aseptic interventions, reducing minor documentation errors and lowering the number of PQ execution deviations tied to human factors.
Section TL;DR: AST Academy translates Annex 1/FDA expectations into role-based training that supports CQV execution, reduces human-factor deviations, and improves inspection readiness.
Partnership with CURIS: 7% VPHP Isolator Decontamination
Decontamination is a defining capability for aseptic isolators because it directly impacts sterility assurance, cycle time, material compatibility, and total equipment uptime. In 2025, AST expanded decontamination options through a partnership with CURIS Decontamination System using VPHP (Vapor Phase Hydrogen Peroxide) at 7% hydrogen peroxide concentration.
What’s different vs. conventional VHP systems: many traditional vaporized hydrogen peroxide approaches use higher peroxide concentrations, which can increase oxidative stress on certain polymers and elastomers and may drive longer aeration to reach safe residual levels. A validated 7% VPHP strategy is positioned to reduce peroxide loading and support faster aeration, while still achieving strong microbial lethality when distribution, dwell time, and humidity/condensation control are engineered appropriately.
Typical validation expectations and performance targets (examples):
- Biological indicator (BI) targets: commonly ≥6-log reduction for resistant spores (often Geobacillus stearothermophilus) in worst-case locations; many programs also define acceptance for vegetative organisms based on facility EM flora risk assessments.
- Cycle development parameters: users typically qualify peroxide concentration/ppm profile, temperature, relative humidity, distribution (e.g., multi-point sensors), and aeration endpoint criteria; aeration acceptance often includes meeting defined residual peroxide limits and/or room/isolator safety thresholds per site EHS requirements.
- Repeatability: multiple consecutive successful cycles under worst-case load and configuration are typically expected, plus requalification triggers tied to maintenance, isolator changes, or CCS updates.
Example cycle-time ranges (illustrative and load-dependent):
- Empty chamber / minimal load: decontamination + aeration often targeted in the ~45–90 minute range, depending on isolator volume, distribution design, and aeration capacity.
- Typical production load: commonly ~60–120 minutes total cycle time when accounting for loading patterns, surface area, and material off-gassing.
- Worst-case load / complex tooling: can extend to ~90–180 minutes if surface area, shadowing, or absorption increases aeration demand.
AST notes aeration can be achieved “in as little as 15 minutes” in applicable configurations; in practice, manufacturers confirm this during PQ using their specific isolator, HVAC/abator setup, and worst-case load patterns.
Implementation considerations (practical):
- Infrastructure: confirm aeration capacity (air changes, catalyst/abatement approach, exhaust routing), sensor placement strategy, and peroxide-safe materials for components inside the isolator.
- Validation/change control: plan a structured cycle development protocol (including worst-case load definition, BI placement rationale, and requalification strategy) and update your Annex 1 contamination control strategy to reflect the new decontamination approach.
Anonymized scenario: A CDMO running frequent product changeovers in an isolator-based filling line adopted low-concentration VPHP to reduce total turnaround time between campaigns and to broaden compatibility with certain plastics and seals used in single-use assemblies—supporting higher OEE without relaxing CCS expectations.
Useful references: EU GMP Annex 1 is the primary European benchmark for sterile manufacturing expectations (EudraLex Volume 4), while the FDA aseptic processing guidance above is widely referenced globally.
Section TL;DR: 7% VPHP aims to maintain ≥6-log spore lethality while reducing peroxide burden and supporting faster aeration; cycle time and acceptance criteria must be proven under worst-case loads in PQ and reflected in the CCS.
Shield® GIT: Advanced Wireless Glove Integrity Testing

Glove integrity is a cornerstone of isolator-based aseptic processing because glove breaches can create a direct contamination pathway. EU GMP Annex 1 explicitly increases emphasis on glove integrity management as part of the contamination control strategy, including routine testing and investigation of failures.
In 2025, AST introduced Shield® GIT, a fully integrated wireless glove integrity testing system. For clarity, GIT here refers to glove integrity testing; common approaches include pressure decay (inflating the glove to a set pressure and measuring pressure loss) or alternative methods such as flow-based testing depending on design and standards used.
Test methods and how limits are defined (practical overview):
- Method selection: many isolator programs use pressure decay because it is quantitative and can be trended; the glove is pressurized to a defined setpoint and monitored for pressure loss over a defined time window.
- Alarm thresholds/limits: limits are typically established during method qualification using known leak standards or characterized defects, then set to balance sensitivity (detect small leaks) and false rejects; sites often implement alert and action thresholds aligned to their deviation/CAPA process.
- Data integrity: results should be attributable, time-stamped, and protected; many regulated environments align electronic records to 21 CFR Part 11 expectations (electronic records/e-signatures) and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
Why this matters operationally: A well-designed glove integrity program reduces contamination risk, supports smoother investigations, and can reduce batch impact by enabling earlier detection—before compromised gloves affect critical operations.
Implementation considerations (practical):
- Infrastructure: define testing frequency (routine, post-intervention, post-maintenance), glove port mapping, and how the wireless components will be powered/maintained without introducing contamination risk.
- Validation/change control: qualify the method (repeatability, reproducibility, leak detection capability), establish alert/action limits, and ensure audit trails and access controls meet your data integrity requirements.
Anonymized scenario: A manufacturer running high-intervention processes (frequent manual adjustments) used routine glove integrity test trending to identify a specific port with elevated failure rates, enabling targeted maintenance and reducing glove-related deviations over subsequent campaigns.
Section TL;DR: Shield® GIT supports Annex 1-aligned glove integrity management using quantitative testing (commonly pressure decay) with defined alert/action thresholds and compliant electronic records to reduce contamination risk and deviations.
AST’s Digital Twin Tool: Enabling Pharma 4.0 in Fill-Finish
Digitalization and real-time data are reshaping sterile drug product manufacturing under the umbrella of Pharma 4.0 (an industry approach to connected, data-driven manufacturing). In response, AST introduced a digital twin tool for fill-finish systems—intended to shorten project timelines, reduce start-up risk, and improve ongoing performance.
A digital twin is a dynamic virtual representation of an actual machine or system. In a regulated aseptic fill-finish environment, the digital twin becomes most useful when it is anchored to real operational data and strong data integrity controls.
Example data types and how they drive use cases:
- SCADA tags (Supervisory Control and Data Acquisition): real-time states for pumps, valves, servo positions, and interlocks—used for cycle-time analysis, root-cause investigation, and simulation of line states.
- Sensor data: temperatures, pressures, flow rates, fill volumes/weights, isolator pressure differentials, and environmental readings—used to detect drift, support predictive maintenance, and evaluate process capability.
- Batch data / eBR (electronic batch record): recipe parameters, setpoints, holds, and operator actions—used to connect deviations to specific steps and support continued process verification.
- Alarm and event logs: fault codes, warnings, and interlock trips—used to quantify top downtime drivers and reduce repeat deviations.
Example KPIs enabled by these data streams:
- OEE (Overall Equipment Effectiveness): availability losses from alarms/stops, performance losses from minor stops or speed reductions, and quality losses from rejects.
- Cycle time: decontamination turnaround time, filling cycle variability, changeover duration, and recovery time after alarms.
- Deviation rate: deviations per batch/run, top deviation categories (e.g., glove integrity failures, alarms, EM excursions), and time-to-close.
Regulatory and data integrity framing: digital tools should preserve audit trails, enforce access controls, and support electronic record integrity consistent with 21 CFR Part 11 expectations and ALCOA+ principles—especially when used to support batch disposition decisions or regulated reporting.
Implementation considerations (practical):
- Infrastructure: define connectivity architecture (network segmentation, historian/edge gateway strategy) and tag standards so data is usable across FAT, SAT, and production.
- Validation/change control: determine intended use (training vs. decision-support vs. closed-loop optimization), then validate accordingly (e.g., requirements, test scripts, and audit trail verification).
Anonymized scenario: A biotech launching an ATMP clinical line used a digital twin during FAT to simulate alarms and recovery steps; post-installation, the same model helped identify a recurring micro-stop pattern tied to a sensor threshold, improving availability and reducing batch interruptions.
Section TL;DR: The digital twin connects SCADA tags, sensor data, batch records, and alarm logs to improve OEE, cycle time, and deviation reduction—while requiring Part 11/ALCOA+ aligned data integrity controls.
How These Solutions Work Together in a Typical Project (Concept to CQV to Routine Operation)

In a typical new clinical fill-finish line project (e.g., a modular isolator-based filling line for a parenteral product), these elements can be deployed as a connected lifecycle:
- Concept & design: contamination control strategy definition (Annex 1 CCS), isolator and airflow/First Air design decisions, and decontamination approach selection (e.g., 7% VPHP vs. conventional systems) based on turnaround and material compatibility needs.
- Factory build & FAT: digital twin scenarios used to test line states, alarm handling, and operator workflows; Shield GIT method setup and draft limits; initial draft SOPs and training plans.
- Installation & CQV: AST Academy supports role-based readiness; 7% VPHP cycle development and performance qualification under worst-case loads; glove integrity test method qualification and data integrity verification; execution of IQ/OQ/PQ aligned with risk assessments.
- Routine operation: trend glove integrity results, decontamination cycle metrics, and alarm/event downtime; use digital twin insights to reduce repeat deviations and standardize recovery actions; maintain requalification triggers and CCS updates under change control.
Section TL;DR: Training, low-concentration VPHP, glove integrity testing, and digital twin capabilities can be sequenced across design→FAT→CQV→operations to reduce start-up risk, improve uptime, and strengthen Annex 1 CCS execution.
Thought Leadership and Industry Contributions
AST’s 2025 thought leadership activities were positioned to translate regulatory expectations into practical engineering and quality execution—helping manufacturers improve EM program design, reduce contamination risk, and strengthen readiness for regulatory inspections.
Section TL;DR: Conferences, articles, webinars, and papers were used to turn Annex 1/FDA expectations into actionable design, validation, and monitoring practices.
ISPE Annual Meeting & Expo: 7% VPHP in Aseptic Isolators

At the 2025 ISPE Annual Meeting & Expo, AST leaders presented on developing and applying 7% VPHP for isolator decontamination in aseptic filling lines. In practical terms, these discussions help manufacturers define defendable PQ protocols (worst-case loads, BI placement rationales, and aeration endpoints) that hold up during inspections.
Topics included:
- Design considerations for integrating low-concentration VPHP systems
- Validation protocols and performance criteria across multiple isolator configurations
- Data demonstrating >6-log microbial reductions (commonly using spore BI challenges)
- Impacts on downtime, material compatibility, and EHS risk profile vs. higher-concentration approaches
Section TL;DR: The ISPE session emphasized inspection-ready validation strategies for 7% VPHP, focusing on worst-case qualification and reduced downtime without compromising sterility assurance.
Pharma 4.0 and Digital Twin: Insights from AST’s CTO
In the October 2025 issue of Cleanroom Technology, AST CTO Steven Ng discussed practical application of Pharma 4.0 principles with an emphasis on digital twin value—particularly for shortening troubleshooting cycles and improving decision-making using reliable manufacturing data.
Key guidance areas included:
- Assessing operations for digital readiness (data availability, tag governance, historian access)
- Identifying high-impact use cases (virtual commissioning, alarm reduction, predictive maintenance)
- Leveraging data for process control and quality assurance while protecting integrity (audit trails, controlled access)
- Aligning digital strategies with regulatory expectations for electronic records
Section TL;DR: Digital twin adoption is most effective when tied to specific use cases and governed by strong data integrity practices aligned with regulated manufacturing.
First Air and Annex 1: A Design-Centered Perspective

The revised EU GMP Annex 1 places renewed emphasis on air quality, airflow visualization, and First Air (the concept that the first air contacting critical surfaces should be of the highest quality and unobstructed). In a February 2025 Cleanroom Technology article, AST discussed how isolator design and airflow visualization can reduce contamination risk at critical points—supporting smoother Annex 1 compliance and stronger CCS documentation.
Section TL;DR: First Air and airflow visualization are practical design levers that reduce contamination risk and strengthen Annex 1 CCS defensibility.
Environmental Monitoring and Contamination Control Strategy
Environmental Monitoring (EM) is a core component of a contamination control strategy in aseptic manufacturing. AST and Particle Measuring Systems co-presented a webinar on automated active microbial collection—helping teams design EM programs that are both more reliable and less disruptive to operations.
The webinar addressed:
- Integrating EM technologies into filling line design to reduce interventions
- Best practices for EM operations and event response (including investigation readiness)
- Approaches to minimize contamination risk while maintaining uptime
- How automation and consistent data capture can reduce interpretive ambiguity during inspections
Section TL;DR: Better EM integration and automation can reduce interventions, improve data consistency, and strengthen investigation/inspection readiness.
White Paper: Zero-Waste Strategies in Sterile Injectable Manufacturing

AST published a white paper on automation, robotics, and implementing real-time IPC (In-Process Control) to support patient-centric, high-value parenteral therapies. These themes are particularly relevant for ATMPs and other expensive biologics where yield loss directly affects patient access and cost of goods.
Highlights included:
- The evolution of quality control measures in sterile filling
- Zero-waste approaches in fluid handling and dispensing
- IPC strategies for targeted, high-value injectable products
- An overview of augmented IPC concepts enabling higher-frequency checks with minimal speed impact
Section TL;DR: Real-time IPC and zero-waste strategies help protect yield for high-value parenterals and support more consistent quality outcomes.
Honoring 60 Years of AST and Looking Ahead
In April 2025, AST marked its 60th anniversary—reflecting a long-term focus on automation for life sciences. Looking ahead, sterile drug product manufacturers face converging pressures: accelerated timelines, tighter contamination control expectations, and increased scrutiny of data integrity and risk management.
From strategic partnerships and technical solutions to expanded services and thought leadership, 2025 positioned AST’s approach around the full lifecycle: concept through CQV and into routine operation—supporting Annex 1 contamination control strategy execution and alignment with FDA aseptic processing guidance.
Section TL;DR: The 2025 focus aligned technology and services to lifecycle delivery (design→CQV→operations) under Annex 1/FDA expectations and modern quality-system principles.
Key Takeaways for Sterile Drug Product Manufacturers

- Design the CCS early: tie isolator design, First Air, EM, glove integrity, and VPHP decontamination decisions back to a defensible Annex 1 contamination control strategy.
- Validate for worst case: qualify 7% VPHP cycles and glove integrity test limits under worst-case load/configuration to reduce deviation risk in routine operation.
- Use digital twins for measurable KPIs: connect SCADA tags, alarm/event logs, batch data, and sensor data to improve OEE, cycle time, and deviation rate in isolator-based filling lines.
- Train to reduce human-factor risk: role-based cGMP/CQV training strengthens execution during IQ/OQ/PQ and supports smoother inspections.
- Build for ATMP reality: modular aseptic fill-finish equipment and data-driven operations are particularly valuable for ATMPs and other low-volume, high-mix parenteral manufacturing.
Section TL;DR: Combine CCS-driven design, worst-case validation, data-driven KPIs, and targeted training to improve sterility assurance, uptime, and inspection readiness in isolator-based filling lines.
FAQ
Q: What are typical validation targets for 7% VPHP decontamination in aseptic isolators?
A: Many programs target ≥6-log reduction using spore biological indicators (commonly Geobacillus stearothermophilus) placed in worst-case locations (e.g., shadowed areas, high surface-area tooling). Validation typically includes demonstrating repeatable cycle performance, defined aeration endpoints (site-specific residual/safety limits), and documented worst-case load configurations, with requalification triggers managed under change control.
Q: What are key prerequisites for adopting 7% VPHP in an existing isolator-based filling line?
A: Key prerequisites usually include:
- Engineering fit: adequate aeration capacity (air changes/exhaust routing), compatible materials inside the isolator, and a sensor strategy to confirm distribution.
- Quality planning: an approved cycle development/qualification protocol defining worst-case loads, BI strategy, and acceptance criteria.
- Regulatory alignment: updates to the Annex 1 contamination control strategy and supporting SOPs.
- Change control: formal assessment of impact to validated state, including requalification scope and training updates.
Q: How does a digital twin help improve OEE and reduce deviations on aseptic fill-finish equipment?
A: A digital twin can link SCADA tags, sensor signals, batch steps, and alarm/event logs to quantify the biggest downtime and deviation drivers (e.g., top alarms causing stops, recurring micro-stops, or threshold-related nuisance faults). Manufacturers can then test parameter changes virtually, standardize recovery procedures, and trend improvements in OEE, cycle time, and deviation rate while maintaining audit trails and data integrity controls consistent with 21 CFR Part 11 and ALCOA+.
Q: What are typical steps to deploy a digital twin for an isolator-based filling line?
A: Typical steps include:
- Define intended use (training, virtual commissioning, troubleshooting, KPI reporting).
- Confirm data sources (SCADA tags, historian, alarms/events, batch records) and tag naming standards.
- Set up connectivity and cybersecurity segmentation (e.g., OT/IT boundaries).
- Configure KPIs (OEE, cycle time, deviation categories) and dashboards/reports.
- Execute validation commensurate with use (requirements, testing, audit trail verification) under change control.
Q: What implementation timeline should manufacturers expect for a GENiSYS C line with an Atmos isolator, including CQV?
A: Timelines vary by scope (new build vs. retrofit), utilities readiness, and batch strategy (clinical vs. commercial). Many projects plan in phases: design/finalization and build, FAT, shipment/installation, SAT, then IQ/OQ/PQ including media fills. A practical approach is to establish a detailed integrated project schedule early—linking utilities, automation readiness, decontamination cycle development, glove integrity method qualification, and operator training—so CQV activities are not compressed at the end.
Q: How does AST support CQV and regulatory inspection readiness for sterile drug product manufacturing?
A: Support commonly includes structured CQV documentation and execution (URS-to-test traceability, FAT/SAT protocols, IQ/OQ/PQ), training for operators/maintenance/QA, and contamination control strategy alignment to Annex 1 and FDA aseptic processing guidance. Digital tools and testing systems can also strengthen inspection readiness by improving traceability, trending, and electronic record integrity when configured under appropriate data governance.
