Single Use Technologies & Disposables refer to biopharmaceutical manufacturing (bioprocessing) equipment designed to be used once (or for a single manufacturing campaign) and then discarded.
PE Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
PE Articles
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Product
Good Practice Guide: Single-Use Technology
Single-use technology has grown in both complexity of design and criticality of application in the…
iSpeak Blog
End-Of-Life Management for Single-Use Products in Bioproduction
Users Perspective on End of Life Management for Single-Use Products used in Bioproduction
PE Articles
Introducing CoP Leader Profiles: Javier Lozano
With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities…
PE Articles
Supporting Cell & Gene Therapy through Multimodal & Flexible Facilities
Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for…
iSpeak Blog
Survey: How Does Your Company Dispose of Single-Use Assemblies?
Single-use plastics are critical for healthcare, life sciences laboratories, and bioprocessing. They…
Video
Cold Chain Management – How to Move Frozen Substances Across the Globe in a Safe & Simple Manner
Complimentary Learning Level: Intermediate Session Length: 1 hour Moving frozen drug substances is…
iSpeak Blog
Best Practices for CDMOs Dealing with Data Mayhem
It would be easy to say that the pandemic has driven dramatic growth for CDMO companies, as more…
iSpeak Blog
How does your Company Dispose of Single-Use Plastics?
Single-use plastics are critical for healthcare, life sciences laboratories, and bioprocessing. They…
iSpeak Blog
Benefiting from Emerging Technologies
When most people hear “Facility of the Future,” they immediately think about robots, automation…
iSpeak Blog
Join Us for a Round Table Discussion on Single-Use Supply Shortage Crisis
COVID-19 has caused disruptions and delays with supply chain all across the world. Single-Use…
Guidance Documents
Single Use Technologies & Disposables (1)
Supply Chain Management (1)
Community Discussions
Community Discussions
Pharmaceutical Engineering Magazine Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Introducing CoP Leader Profiles: Javier Lozano
With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities…
Supporting Cell & Gene Therapy through Multimodal & Flexible Facilities
Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for…
Biopharma Facility Design: Lessons Learned on the Dance Floor
In 2014, Pharmaceutical Engineering® published an article, “ Lessons Learned in the Ballroom,”…
Webinars
Videos
Video
Cold Chain Management – How to Move Frozen Substances Across the Globe in a Safe & Simple Manner
Complimentary Learning Level: Intermediate Session Length: 1 hour Moving frozen drug substances is…
Video
Selection of Single-Use Components Webinar
Learning Level: Basic - Implementation of Single-Use Systems (SUS) starts with an effective…
Video
ISPE Good Practice Guide: Single-Use Technology
A Road Map to Implement Single-Use Technology Single-use technology (SUT) has grown in both…
iSpeak Blog Posts
Professional Development Training
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
White Papers
January / February 2025
The landscape of clinical trials has been transformed in a post-pandemic world. The first edition of…
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…
