Microbiological and viral contamination control (Microbio Contam Ctrl) refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mold, fungi, virus, prions, protozoa, or their toxins and by-products.
PE Articles
Alcohols for Use as an Antimicrobial Agent
In healthcare and pharmaceutical settings, alcohol refers to two water-soluable chemical compounds…
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
Regulators on Annex 1 Implementation
Insight from Austria’s Regulatory Authority Representative At the 2024 ISPE Aseptic Conference, held…
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
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
PE Articles
Selection Criteria for Pharmaceutical Containment Equipment
Pharmaceutical manufacturing facilities produce a variety of products, including highly potent…
PE Articles
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the…
iSpeak Blog
Empowering the Aseptic Workforce: Training and Continuous Learning as an Enabler for Success
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical…
iSpeak Blog
The Future of Aseptic Manufacturing: Digitalization and Advanced Technologies
The 2024 ISPE Aseptic Conference will offer a glimpse into the best discussions on the future of…
PE Articles
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
Product
Good Practice Guide: Process Gases 2nd Edition
The ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction…
iSpeak Blog
Annex 1 in Force! Join the First Discussion after the 25 August Effective Date
PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25…
Guidance Documents
Containment (3)
Critical Utilities (6)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Manufacturing Operations (2)
Microbiological & Viral Contamination Control (17)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
- Good Practice Guide: Assessing Particulate Containment 2nd Edition..
- Good Practice Guide: Containment for Potent Compounds
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: HVAC & Process Equipment Air Filters
- Good Practice Guide: Asset Management
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Oral Solid Dosage (1)
Quality Control (2)
Quality by Design (1)
Regulatory (2)
Sterile Products (1)
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (4)
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Nov 20, 2024
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Regulatory
Nov 18, 2024
Regulatory
Regulatory
Nov 17, 2024
Sustainable Facilities, HVAC, & Controlled Environments
Manufacturing Operations
Nov 17, 2024
Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Nov 03, 2024
Women in Pharma®
Webinars
iSpeak Blog Posts
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…
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
Selection Criteria for Pharmaceutical Containment Equipment
Pharmaceutical manufacturing facilities produce a variety of products, including highly potent…
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the…
Cold Systems as a Solution to Decarbonize Water Purification
The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions…
Air Speed Qualification: At Working Position or Working Level?
The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the…
Cleanroom Recovery Study: Using Computational Fluid Dynamics Methodology
Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a…
Contamination Trends & Proposed Solutions
Contamination is one of the top reasons for medicinal product recall by the US Food and Drug…
Novel Dry Decontamination Method Using Gaseous Chlorine Dioxide
Chlorine dioxide has been shown effective in decontaminating various types of chambers and volumes…
![Figure 1: Seasonal comfort (temperature and RH). ©ASHRAE, www.ashrae.org. Used with permission from 2017 ANSI/ASHRAE Standard 55 [4].](/sites/default/files/styles/teaser_image/public/2021-08/0921_PE_SO_TechHaycock_01.jpg?itok=mJiPGN_X)
Temperature & Humidity Requirements in Pharmaceutical Facilities
Defining room temperature and humidity limits is a frequent topic of debate when designing and…
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…
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.
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.
Cleaning Validation Principles Training Course
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.
CIP System Design, Integration and CIP Chemicals Training Course
This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue
Featured Conferences
White Papers
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…