IMA for:
Hover an industry on the left menu, see the full list or type your search:
IMA for: Pharmaceutical
IMA for: Food
IMA for: Coffee
IMA for: Tea & Herbs
IMA for: Personal Care
IMA for: Tissue & Nonwoven
IMA for: Tailored Technologies
IMA for: E-Commerce
IMA for: Automation
IMA Life is pleased to take part in the 2026 PDA Good Aseptic Manufacturing Conference, taking place on June 11-12 in Frankfurt, Germany. Under the theme “Future-Proofing of Aseptic Manufacturing: Investing in Superior Solutions”, the conference will focus on the most critical topics currently transforming sterile manufacturing, from regulatory alignment and Annex 1 implementation to advanced aseptic technologies and the growing role of automation and digitalization.
Over two days, the event will bring together regulators, manufacturers, and technology providers to share practical insights, innovative solutions, and forward-looking strategies to strengthen compliance, quality, and operational excellence in aseptic manufacturing.
Don’t miss IMA Life’s presentation:
“Innovative Microbiological Sampling Strategies in Grade A Gloveless Isolators for ATMP Manufacturing” • presented by Alessandra Benassi Microbiology and Sterility Assurance Team Leader – IMA Life, together with Valentina Casalone, Sterility Assurance Senior Quality Manager – Thermo Fisher Scientific on Thursday, June 11, from 3:20 PM to 3:40 PM.
Abstract:
Advanced Therapy Medicinal Products (ATMPs) require stringent aseptic conditions due to their complex, often manual, and aseptic manufacturing processes. Their characteristics often exclude the possibility of terminal sterilization making them vulnerable to contamination via poor aseptic practice. This presentation outlines the strategic approach adopted by Thermo Fisher, a Contract Development and Manufacturing Organization (CDMO), to ensure robust microbiological control within Grade A environments operated under gloveless isolator technology.
The transition from traditional open systems to closed isolator systems is a journey the industry is familiar with. The further move to fully robotic gloveless isolators represents a paradigm shift in removal of personnel from product contact, enhancing contamination control and significantly reducing human intervention and associated risks. Thermo Fisher implemented a comprehensive contamination control strategy, integrating risk-based environmental monitoring, automated bio-decontamination VPHP (Vapour Phase Hydrogen Peroxide) cycles, and advanced sampling techniques tailored to the isolator’s design. Particular attention was given to the validation of sampling points, frequency, and methods to align with EU GMP Annex 1 and guideline requirements.
This case study highlights the challenges and solutions in adapting microbiological sampling protocols to a fully automated, gloveless isolator system, including the use of innovative microbiological methods. The outcome demonstrates improved sterility assurance, reduced batch failure rates, and enhanced operational efficiency, supporting the scalability and regulatory compliance of ATMP manufacturing.
Join the discussion at Booth No. 34 and explore the latest aseptic processing innovations with our experts.
We look forward to connecting with you!