Sterile products processing relates to how sterile drug products are manufactured using aseptic (or free from contamination) process methods where the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined and filled into a container (such as a syringe)
Related Guidance Documents
Manufacturing Operations (1)
Microbiological & Viral Contamination Control (1)
Sterile Products (1)
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Webinars Related to Sterile Product Processing
iSpeak Blog Posts Related to Sterile Product Processing
PE Magazine Related to Sterile Product Processing
Enhanced Intervention Detection in Aseptic Fill Using AI/ML
We will show how continuous, real-time capturing of data with immediate data analysis by an ML…
Communities of Practice Profiles: Meet the Sterile Products Processing CoP
The members of the Sterile Products Processing (SPP) Community of Practice (CoP) Steering Committee…
Message From the Chair: Heading Toward a New Annex 1 and ISPE Annual Meeting
Summer is over and we are all back to our workplaces. This year has been different than the two…
Validation of Aseptic Processes Using Media Fill
Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and…
Safeguarding Vial Container Closure Integrity: A Systematic Approach
Any systematic pharmaceutical engineering approach for ensuring vial container closure system (CCS)…
2021 ISPE Aseptic Conference Regulatory Panel
The 30th ISPE Aseptic Conference culminated in the interactive regulatory panel, which offered…
ISPE Aseptic Conference Turns 30
The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March…
Using CFD Multiphase Modeling to Predict Bioreactor Performance
Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up…
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the…
Videos Related to Sterile Product Processing
Training Courses Related to Sterile Product Processing
Aseptic Processing & Annex 1 Training Course
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
Concept and Discussion Papers
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance
Introduction Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers…
Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails
Abstract Plug & play in general describes a piece of equipment that is ready to use upon connecting…
