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)
PE Articles
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
Product
Good Practice Guide: Unique ID of Glass Primary Containers
Published: May 2024 Pages: 86 Table of Contents Special Pricing for Emerging Economies Many current…
PE Articles
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
iSpeak Blog
Empowering the Aseptic Workforce: Training and Continuous Learning as an Enabler for Success
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical…
iSpeak Blog
ATMP Cleanroom Facilities: A Roadmap for Success
What is the Route to Successful ATMP Cleanroom Development? Mitch Gonzales, Vice President of…
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
Video
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
PE Articles
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
iSpeak Blog
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has…
Video
Medical Device Sterilization with FDA
Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Session…
iSpeak Blog
New ISPE Guide Highlights Best Practices and Benefits of Unique Identification of Glass Containers
Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at…
PE Articles
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
Product
Good Practice Guide: Unique ID of Glass Primary Containers
Published: May 2024 Pages: 86 Table of Contents Special Pricing for Emerging Economies Many current…
PE Articles
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
iSpeak Blog
Empowering the Aseptic Workforce: Training and Continuous Learning as an Enabler for Success
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical…
iSpeak Blog
ATMP Cleanroom Facilities: A Roadmap for Success
What is the Route to Successful ATMP Cleanroom Development? Mitch Gonzales, Vice President of…
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
Video
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
PE Articles
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
iSpeak Blog
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has…
Guidance Documents
Manufacturing Operations (1)
+Microbiological & Viral Contamination Control (1)
+Packaging (1)
+Sterile Products (2)
+Community Discussions
Community Discussions
Apr 08, 2025
Validation
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Webinars
Upcoming
On-Demand
iSpeak Blog Posts
Pharmaceutical Engineering® Magazine
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…
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…
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…
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…
Videos
Professional Development Training
Aseptic Processing & Annex 1 Training Course
+White Papers
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
