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.
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 (16)
- 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: 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 (3)
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Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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
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September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
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May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…