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.
Product
Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
iSpeak Blog
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has…
PE Articles
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
PE Articles
Energy-Optimized Cleanroom Planning
Cleanroom technology is a particularly promising starting point when it comes to energy optimization…
iSpeak Blog
Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing
The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of…
Product
Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
Published: October 2024 Pages: 156 Table of Contents Special Pricing for Emerging Economies This…
PE Articles
Ultraviolet Treatment for Chlorine & Chloramine Reduction
Trojan Technologies provides innovative physical water treatment solutions for municipal, industrial…
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…
Guidance Documents
Containment (3)
Critical Utilities (5)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (16)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- 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: Membrane-Based WFI Systems
- 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 (3)
Sterile Products (1)
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (3)
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
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
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 UK Medicines and Healthcare Products…
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…
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
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…