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)
iSpeak Blog
Smart Strategies for Aseptic Filling Line Setup
This blog post produced by the ISPE D/A/CH CoP Aseptic Processing – Subgroup Appropriate…
iSpeak Blog
From Technical Expertise to Leadership: Supporting Career Advancement in Life Sciences
Career advancement in the life sciences sector is increasingly shaped by the ability to integrate…
PE Articles
New Good Practice Guide: ATMPs – Equipment Design and Qualification for Cellular Therapy Manufacturing
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for…
iSpeak Blog
Upgrading Freeze-Dryer Loading for Annex 1 Compliance: Key Insights Ahead of the 2026 ISPE Aseptic Conference
As regulatory expectations around aseptic manufacturing continue to evolve, Annex 1 has sharpened…
iSpeak Blog
Crisis Management and Partnership with US Food and Drug Administration (US FDA): North Cove’s Recovery After Hurricane Helene
In September 2024, Hurricane Helene, a category 4 hurricane, hit the Baxter North Cove facility in…
iSpeak Blog
Explore the Future of Radiopharmaceuticals, High Potency Compounds, and Facility Design at the ISPE Aseptic Conference
Aseptic manufacturing has a highly complex set of requirements to protect patients. Add other…
iSpeak Blog
Is Aseptic Processing at Risk? Navigating New Demands
This Year’s Trends Are Different For over a decade, the aseptic processing industry has pushed…
iSpeak Blog
Aseptic Innovation in Focus: 2025 Session Takeaways Ahead of the 2026 ISPE Aseptic Conference
Explore two standout sessions from the 2025 ISPE Aseptic Conference that offer a glimpse into the…
iSpeak Blog
Reasons to Attend the Component Quality Track at the 2026 ISPE Aseptic Conference in Washington, D.C., USA
The movement toward ready-to-use (RTU) and ready-to-fill (RTF) primary packaging has reached a…
Video
AI-Guided Process Analytical Technology for Real-Time Sterility Assurance
AI-Guided Process Analytical Technology for Real-Time Sterility Assurance Complimentary Learning…
iSpeak Blog
New ISPE Good Practice Guide: Advanced Therapy Medicinal Products (ATMPs) – Equipment Design and Qualification for Cellular Products
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for…
iSpeak Blog
Discover the Future of Sterile Manufacturing at the 2026 ISPE Aseptic Conference
ISPE has once again assembled the most comprehensive industry conference on aseptic manufacturing…
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Guidance Documents
Advanced Manufacturing (1)
Advanced Therapy Medicinal Products (1)
Manufacturing Operations (1)
Microbiological & Viral Contamination Control (1)
Community Discussions
Community Discussions
Mar 18, 2026
Data Integrity
Mar 12, 2026
Mar 11, 2026
Data Integrity
Mar 11, 2026
Advanced Therapy Medicinal Products
Biotechnology
Mar 05, 2026
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering® Magazine
New Good Practice Guide: ATMPs – Equipment Design and Qualification for Cellular Therapy Manufacturing
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for…
Volunteer Profile: Massimiliano Cesarini, Sterile Products Processing Community of Practice Chair
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his…
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
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…
Videos
Professional Development Training
Aseptic Processing & Annex 1 Training Course
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
White Papers
March / April 2026
As technological advances sweep the pharmaceutical industry, this issue explores C&Q digitalization…
January / February 2026
As the pharmaceutical landscape continues to evolve, this issue highlights use of AI and GAMP ®…
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
