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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Jun 13, 2024
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Pharmaceutical Engineering Magazine Articles
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…
Featured Conferences
Webinars
Videos
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…
iSpeak Blog Posts
Conferences
Professional Development Training
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. Course Price: $300 (non-member) / $270 (member) Buy Now Return to Online Learning
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. Buy Now Return to…
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.
GMP Refresher
Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…
Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course
The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.