Thomas Altmann
Global Technical Consultant
Thomas Altmann has 26 years’ experience in cleaning chemistry, cleaning process, cleaning validation and regulatory compliance. As Technical Consultant, he provides technical consultation on cleaning and sanitization processes optimization for pharmaceutical, API, biotechnology and personal care manufacturers globally. In his role Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical production equipment. He is a member of ASTM E55 WK15778 Cleaning Process Development & Validation Team and worked on the ASTM E3106 standard guide. Thomas is an active member of the Parenteral Drug Association (PDA) working on Cleaning Validation Process updates like the Technical Report 29.
DAY 2: May 29th, 2026
SESSION: Cleaning process development and cleaning agent selection
◆ Regulatory expectations.
◆ Laboratory bench scale studies / cleanability trials.
◆ Implementation of cleaning process on-site.
◆ Levels of cleaning and level of documentation requiered.
SESSION: Limit setting and visual clean – how does this fit together?
◆ Limit calculation for cleaning validation (HBEL, fixed limits, TTC)..
◆ Points to consider for limit setting.
◆ Visual clean – regulatory requirements.
◆ Determination of visual residues limit (VRL).
◆ Case study Paracetamol and visual clean.
DAY 1: October 1st, 2025
SESSION: Cleaning Process Development
◆ Regulatory expectations.
◆ Laboratory bench scale studies / cleanability trials.
◆ Implementation on-site.
◆ Levels of cleaning and level of documentation.
DAY 1: September 28th, 2023
SESSION: Cleaning Process Development for HPAPIs and Final Dosage Forms
◆ Cleaning process development studies.
◆ Solubility considerations for lab testing.
◆ Cleanability and excipients.
◆ Cleaning validation requirements for detergents.
