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
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
Product
Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 3rd Edition
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
PE Articles
Using Isolators and Bio-Decontamination to Future-Proof CGT Processes and Facilities
The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps…
Video
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
iSpeak Blog
Unlock the Future of Aseptic Processing at the 2025 ISPE Aseptic Conference
The pharmaceutical industry continues to face increasing demands for more efficient and effective…
Video
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume
Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
iSpeak Blog
Regulation and Pharma 4.0™ at the 2025 ISPE Aseptic Conference
Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each…
PE Articles
Aseptic Conference Focuses on Technical and Regulatory Issues
The 2025 ISPE Aseptic Conference will be held 17–18 March in Washington, DC, and virtually. Christa…
PE Articles
Enhancing Cleanroom Design: A Deep Dive into Walk-On Ceilings
Walk-on ceilings are one of the more complex architectural features in controlled environments…
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…
Guidance Documents
Containment (3)
Critical Utilities (5)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (16)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 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
Jun 19, 2025
Quality
Lifecycle Management
Validation
Jun 06, 2025
Sustainable Facilities, HVAC, & Controlled Environments
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
Using Isolators and Bio-Decontamination to Future-Proof CGT Processes and Facilities
The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps…
Aseptic Conference Focuses on Technical and Regulatory Issues
The 2025 ISPE Aseptic Conference will be held 17–18 March in Washington, DC, and virtually. Christa…
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…
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
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…