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.
iSpeak Blog
Shaping the Future of Aseptic Manufacturing: Digital Design, Automation, and Airflow Verification
The revised EU GMP Annex 1 has placed renewed emphasis on developing a holistic approach to…
PE Articles
Global Pharmaceutical Manufacturing Leadership Forum (GPMLF): Annex 1 White Paper
This whitepaper provides principles and practical expectations for manufacturing operations within…
iSpeak Blog
Discover the Future of Sterile Manufacturing at the 2026 ISPE Aseptic Conference
ISPE has once again assembled the most comprehensive industry conference on aseptic manufacturing…
iSpeak Blog
Validation of a Depyrogenation Tunnel
This blog post will concentrate on the main points of the Process Design phase and the Process…
PE Articles
Risk-Based Containment Strategy: A Case Study for a Synthetic Molecule API Facility
Containment systems are essential in pharmaceutical manufacturing, ensuring product quality and…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning – Part 4: Aseptic Operational Aspects
Introduction Part 4 Cleanroom garments are worn by operators working in certified cleanrooms to…
PE Articles
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 3 – Aseptic Facility Requirements
Introduction: Part 3 Cleanroom garments are worn by operators working in certified cleanrooms to…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 2 – Operations
Introduction: Part 2 Cleanroom garments are worn by operators working in certified cleanrooms to…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
Introduction: Part 1 Cleanroom garments are worn by operators working in certified cleanrooms to…
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
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
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Guidance Documents
Containment (3)
Critical Utilities (5)
Manufacturing Operations (3)
Microbiological & Viral Contamination Control (16)
- ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
- ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems (Second 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
Mar 10, 2026
Data Integrity
Mar 05, 2026
Mar 04, 2026
Mar 03, 2026
Regulatory
Biotechnology
Containment
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Risk-Based Containment Strategy: A Case Study for a Synthetic Molecule API Facility
Containment systems are essential in pharmaceutical manufacturing, ensuring product quality and…
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
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…
Videos
Professional Development Training
Hands-On Aseptic Processing & Annex 1
This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.
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
January / February 2026
As the pharmaceutical landscape continues to evolve, this issue highlights use of AI and GAMP ®…
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…