Introduction

• Managing Aseptic Interventions
• Aseptic Processing: A Vision of the Future
• The Truth about Interventions in Aseptic Processing

Cleanroom Design & Technology

• Pursuing Efficiency: New Developments in Cleaning Technology
• The Advantages of Restricted-Access Barrier Systems
• Qualification Results of a New System for Rapid Transfer of Sterile Liquid through a Containment Wall
• A New Concept in Aseptic Filling: Closed-Vial Technology
• Aseptic Production, Gowning Systems, and Airborne Contaminants
• Predicted Contamination Levels in Cleanrooms:When Cleanroom-Dressed People are the Contamination Source
• RABS and Advanced Aseptic Processing
• Thinking Inside the Box:The Application of Isolation Technology for Aseptic Processing
• The Next Generation of Aseptic Processing Equipment
• The Application of Robotics to Aseptic Environmental Surface Monitoring
• The Role of Glasses in Aseptic Production: A Detail Often Ignored
• Risk Analysis for Aseptic Processing:The Akers-Agalloco Method
• The Simplified Akers-Agalloco Method for Aseptic Processing Risk Analysis

Filtration

• The Relationship among Pore-Size Ratings, Bubble Points, and Porosity
• Scalable Membrane Ion-Exchange Chromatography Purification of an Antisense Oligonucleotide
• The Use of Model Organisms in Sterilizing Filtration
• The Importance of Pre-Use Integrity Testing in Sterilizing Filtration

Cleaning & Cleaning Validation

• Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient
• A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant Environment
• Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms
• Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
• Isolator Decontamination Using Chlorine Dioxide Gas
• Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
• Guidance for Verification of Biological Indicators: Understanding the acceptance criteria of D-value and population verification is key
• Risk-Management: Assessment of Visible-Residue Limits in Cleaning Validation
• Application of Visible-Residue Limit for Cleaning Validation in a Pharmaceutical Manufacturing Facility
• Correlation of Visible-Residue Limits with Swab Results for Cleaning Validation

Sterilization

• The Effect of Carrier Material on the Measured Resistance of Spores
• Radiation Sterilization of Parenterals
• A Risk-Based Approach to the Use of Biological Indicators in the Development and Control of Steam-Sterilization Processes
• Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
• Understanding Overkill Sterilization: An End to the Confusion