Sustainable Facilities, HVAC, and Controlled Environments focuses on pharmaceutical facility design and manufacture, sustainability of pharmaceutical facilities, heating, ventilation, and air conditioning in pharmaceutical facilities, and other aspects of environmental control in pharmaceutical facilities.
Guidance Documents
Commissioning & Qualification (2)
Containment (2)
Microbiological & Viral Contamination Control (3)
Supply Chain Management (1)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
Community Discussions
Community Discussions
Dec 20, 2024
Dec 19, 2024
GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Dec 11, 2024
Data Integrity
Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Professional Development Training
GMP Fundamentals: Buildings and Facilities
A “GMP Facility” is a building that is used in the production of pharmaceutical and medical device products. The proper design, layout, function and control of such facilities is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course, learners will focus on understanding the building layout, safety, cleanroom conditions, as well as facility sanitation and ventilation of both production and support areas. In this On Demand course (part 4 of 11), you will learn the elements of GMP Buildings & Facilities, as required by regulation. Interactive Course…
Airflow Pattern Visualization (AFPV)
This Airflow Pattern Visualization online course provides a unique opportunity to explore the requirements for airflow pattern visualization and to see different video examples of actual airflow pattern visualization results. The course provides a comparison of different types of airflow patterns, but focuses primarily on unidirectional airflow patterns in critical areas (ISO 5).
HVAC & Environmental Control for Life Science Facilities Training Course
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
White Papers
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…
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…