PDA New England Dinner Meeting & Berkshire Facility Tour

Featured Speaker: Hal Baseman

Hal's topic: An Aseptic Processing Update: Industry and Regulatory Trends and the Path Forward

Abstract: These are remarkable times for the aseptic processing industry. We face challenges to expand manufacturing capability, increase reliability, and embrace innovative technologies – while reducing cost and remaining compliant to global regulatory requirements. To help attendees prepare to meet these challenges this presentation will review recent developments in the aseptic processing of sterile bio-pharmaceutical products. We will address the latest developments on the EMA Annex 1 revision, and the resulting expectations for the use of Quality Risk Management principles. It will discuss topics related to improving aseptic process validation and advanced aseptic processing design, and the impact of ATMP and Cell & Gene Therapy manufacturing.


Featured Speaker: Samantha Kay

Samantha's topic: Hydrogen Peroxide Validation Strategies and Case Studies

Abstract: When vaporized hydrogen peroxide technology is the decontamination method of choice, there are many challenges trying to achieve the proper log reduction and microbiological kill. We will explore validation techniques that analyze hydrogen peroxide exposure and decontamination efficacy. We will also study ways to analyze and reduce hydrogen peroxide residues. Material compatibility is an important factor, and together we will examine Fedegari case studies in order to minimize hydrogen peroxide absorption on sample surfaces and hydrogen peroxide penetration inside bags and aqueous solutions.

Featured Speaker: Shawn Kinney

Shawn's topic: Building Flexibility into Isolator Based Aseptic Processing
Abstract: Isolators, recognized as best in class for sterility assurance, suffer a perception of inflexibility limiting acceptance. BSM, a pioneer in design and use of flexible isolator filling systems, has a manual and a semi-automated flexible isolator-based filling line. Both lines have RTU and bulk vial, syringe and cartridge capabilities. The semi-automated line has lyophilization which handles both RTU and bulk glass capabilities. A new line, under design, will have all the capabilities above with much greater line speed and the capability to decontaminate RTU containers prior to introduction into the isolator. Design features of the three lines will be discussed with special emphasis on benefits of flexible isolator-based filling lines.