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
Validation of a Depyrogenation Tunnel
This blog post will concentrate on the main points of the Process Design phase and the Process…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning – Part 4: Aseptic Operational Aspects
Introduction Part 4 Cleanroom garments are worn by operators working in certified cleanrooms to…
Product
Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products
Published: October 2025 Pages: 122 Table of Contents Special Pricing for Emerging Economies The…
Video
Critical Quality Attributes - Validation of a Parts Washer and Autoclave
Critical Quality Attributes - Validation of a Parts Washer and Autoclave Complimentary Learning…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 3 – Aseptic Facility Requirements
Introduction: Part 3 Cleanroom garments are worn by operators working in certified cleanrooms to…
Video
Sterilizing-grade Filter Validation
Sterilizing-grade Filter Validation Complimentary Learning Level: Advanced Session Length: 1 hour…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
Introduction: Part 1 Cleanroom garments are worn by operators working in certified cleanrooms to…
Video
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing…
PE Articles
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…
iSpeak Blog
Validation of an Automated Glassware Washer
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
News
Alternatives to Testing Sterility in Cell- and Tissue-Based Products
Manufacturers of cell- and tissue-based products are constantly striving to find the right balance…
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
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Dec 08, 2025
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Nov 27, 2025
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Nov 26, 2025
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Nov 10, 2025
Nov 07, 2025
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Nov 06, 2025
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iSpeak Blog Posts
Pharmaceutical Engineering® Magazine
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…
Using CFD Multiphase Modeling to Predict Bioreactor Performance
Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up…
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
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…
July / August 2025
The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device…
