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
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
Pharma 4.0 Enabling Technologies: Use Cases, Benefits and Constraints
At the 2023 ISPE Pharma 4.0™ & Annex 1 Conference in Barcelona, Spain and virtual, Track #6 will…
iSpeak Blog
Eco-friendly Pharma: Sterilization and Sustainable Practices
In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of…
Video
Implementing X-Ray for Single-Use Systems Sterilization: Current Status
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Sterilization by gamma…
Guidance Documents
Manufacturing Operations (1)
Microbiological & Viral Contamination Control (1)
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Jan 26, 2025
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Pharmaceutical Engineering® Magazine
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…
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
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…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
