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.
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Introduction: Part 2 Cleanroom garments are worn by operators working in certified cleanrooms to…
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Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
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Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
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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…
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Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
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Purified Water Microbial Testing: False OOS Due to TNTC vs Filtration Volume Complimentary Learning…
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Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each…
PE Articles
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The 2025 ISPE Aseptic Conference will be held 17–18 March in Washington, DC, and virtually. Christa…
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…
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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…
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Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
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Guidance Documents
Containment (3)
+Critical Utilities (5)
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+Microbiological & Viral Contamination Control (16)
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Pharmaceutical Engineering Magazine Articles
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…
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…
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
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