Containment (Containmt) is the action of confining within a defined space a microbiological agent or other entity that is being cultured, stored, manipulated, transported, or destroyed to prevent or limit its contact with people and the environment. Methods to achieve containment include physical and biological barriers and inactivation using physical or chemical means.1.Primary Containment. Addresses the protection of personnel and the immediate laboratory environment from exposure to infectious agents. It involves using closed containers or biological safety cabinets along with secure operating procedures.
PE Articles
2024 ISPE Aseptic Regulatory Panel Q&A
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and…
PE Articles
Data Analysis of Contamination Control Strategies for Production
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant…
iSpeak Blog
De-Risking Aseptic Processing Operations: Insights from the 2024 ISPE Europe Annual Conference
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of…
PE Articles
Volunteer Leader Profile: Containment CoP Chair Glenn Lawrence, PE
Glenn Lawrence’s first position at Merck & Co. was as a shift engineer for a large factory in Rahway…
PE Articles
Selection Criteria for Pharmaceutical Containment Equipment
Pharmaceutical manufacturing facilities produce a variety of products, including highly potent…
iSpeak Blog
Elevating Contamination Control: From Airflow Studies to Hydrogen Peroxide Applications
Annex 1 has been in effect since August 2023. But what has been its impact? This topic will be…
Product
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
The biopharmaceutical industry has adapted to reflect available technologies such as single-use…
iSpeak Blog
Message from the Chair: What’s Next, What Are the New Trends in Aseptic Manufacturing?
As the 2024 ISPE Aseptic Conference Chair, Christa Myers, Sr. Fellow - Aseptic and Sterile Products…
PE Articles
FDA Regulatory Panel: 2023 ISPE Aseptic Conference
On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a…
PE Articles
2023 ISPE Aseptic Conference Regulatory Panel
On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question…
Product
Good Practice Guide: Assessing Particulate Containment 2nd Edition..
Published: May 2012 Pages: 104 Table of Contents Special Pricing for Emerging Economies The ISPE…
PE Articles
Air Change Rate Reduction during Operation: Success at Roche/Genentech
To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside…
Guidance Documents
Containment (4)
Microbiological & Viral Contamination Control (3)
Quality by Design (1)
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (2)
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2024 ISPE Aseptic Regulatory Panel Q&A
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and…
Data Analysis of Contamination Control Strategies for Production
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant…
Volunteer Leader Profile: Containment CoP Chair Glenn Lawrence, PE
Glenn Lawrence’s first position at Merck & Co. was as a shift engineer for a large factory in Rahway…
Selection Criteria for Pharmaceutical Containment Equipment
Pharmaceutical manufacturing facilities produce a variety of products, including highly potent…
FDA Regulatory Panel: 2023 ISPE Aseptic Conference
On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a…
2023 ISPE Aseptic Conference Regulatory Panel
On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question…
Air Change Rate Reduction during Operation: Success at Roche/Genentech
To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside…
A New Pharmaceutical Equipment Exposure Measurement Database
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which…
Passive Sedimentation Control in Containers Using Marangoni Forces
When fluid-filled containers are stored for long periods of time with negligible motion…
Vision Inspection Using Machine Learning/Artificial Intelligence
Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product…
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Video
Increasing Efficiency through Management of Decontamination Cycles
Extended Learning Learning Level: Intermediate Session Length: 1 hour Processes along the value…
Video
Improved Performance: Implementation of Rapid Microbiological Detection Method
Learning Level: Basic/Intermediate - Sponsored by: Hold times caused by micro QC test have a…
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Conferences
Professional Development Training
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…
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.