Sterile product Manufacture, Asepsis and Control – a specific area of expertise for Galenisys

If you wish to have expert input and assistance for any aspect of sterile product manufacture, then contact us. We have experts who are recognised throughout the industry and who have worked at both shop floor and strategic levels to ensure that sterile product quality is assured, maintained and is in compliance with the requirements of the world’s leading regulatory agencies. Learn from our experts on:

• Facility, equipment and Utility design, use and control
• Aseptic techniques
• Environmental control
• Process design, development and validation
• Process control
• Product inspection
• Filtration
• Sterilisation techniques
• Cleaning and disinfection
• Isolators and RABS
• Personnel activities and behaviours

Our clients can rely on our experts who are at the forefront of sterile product design and are specialists in Quality Systems and Regulatory Requirements. They all have a wealth of experience with both the FDA and the EMA in the realms of sterile product manufacture and control. Our experts include :

Joe Day is a highly experienced Sterility Assurance, Aseptic Processing and Microbiology expert who has held Leadership positions in these functions with several of the world’s leading multinational bio-pharmaceutical companies. Joe has worked intimately and successfully with both FDA and EMA regulatory authorities.

Paul Aboody has many years management and technical experience in Quality (Sterility Assurance) and cGMP Sterile manufacturing facilities (APAs) producing, Parenteral, API, and Tablets. His experience includes auditing of CMOs for Sterile Manufacturing of drug substance & product and close interaction with both FDA and EMA regulatory authoritie