📬 PDA Aseptic Processing of Biopharmaceuticals Conference 2025
Booth Summary Report | Connexo × Novatek (English Version)
1. Event Overview and Key Program Highlights
At the PDA Aseptic Processing of Biopharmaceuticals Conference 2025 held on November 4–5,
Connexo and Novatek jointly operated an exhibition booth, engaging with industry professionals
on the latest topics in aseptic processing, Annex 1 compliance, contamination control,
data integrity, and digitalized quality operations.
The conference covered the following core technical and regulatory themes:
● Annex 1 Implementation & Regulatory Perspectives
- Updated expectations for aseptic facility design and operation
- Key considerations for implementing Automated Visual Inspection (AVI)
- Common gaps and recurring findings in CCS during inspections
● Aseptic Environment Control
- Comparison of EMPQ vs. commercial manufacturing conditions
- Smoke Study enhancement and global regulatory trends
- Contamination case reviews and risk mitigation strategies
● Advanced Technologies & Next-Generation Platforms
- Robotics and Machine Learning applications in aseptic production
- Validation approaches for mRNA, ADC, and other emerging modalities
- Introduction of RTU packaging, E-Beam processing, and high-efficiency filling systems
● Data Integrity & Digital Compliance
- Recurring DI findings during inspections
- ALCOA+–based electronic data management
- Growing importance of real-time quality data and digital QMS
● Supply Chain & Cold Chain Management
- Impacts of geopolitical risks
- Cold chain operational challenges for biologics and cell therapy products
2. Connexo × Novatek Booth Operations
The joint booth highlighted Novatek’s digital quality solutions, focusing on:
- NOVA Stability Management Software
- Cleaning Validation Lifecycle Management
- Environmental Monitoring (EM) Digital System
✔ Visitor Profile
While total booth traffic was moderate,
most visitors were QA, QC, Validation, and aseptic manufacturing professionals,
resulting in highly focused and practical discussions.
✔ Key Areas of Interest
① ICH Stability Management Software
- Automated stability study planning
- Growing interest in chamber monitoring & alarm integration
- Transition from Excel-based manual workflows to digital systems
- Numerous inquiries regarding Part 11 / Annex 11 compliance
② Cleaning Validation
- Increased demand for enhanced cleaning validation post–Annex 1
- Questions on TOC-based verification
- Need for lifecycle-based validation management
- Interest in digitalizing residue limits, SOPs, and equipment/line-specific criteria
③ Environmental Monitoring (EM)
- Rising demand for automated EM data trending
- Need to close the GAP between EMPQ data and operational conditions
- Requests for fully electronic Alarm/Trending/Mapping functions
- Frequent inquiries on linking EM data with Deviation/CAPA workflows
✔ Customer Needs Summary
Visitors consistently expressed a need for
a fully digital, integrated quality environment beyond paper-based operations.
Novatek’s solutions were recognized as capable of addressing both Annex 1 requirements
and real-world operational challenges.