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Increase your asepsis and contamination control!
Decrease your costs and energy consumption!
Manipulation and treatment of biological medicinal substances and of Medicinal Products for Advanced Therapies (ATMP) require specific knowledge for cell manipulation, expansion, and related operations. These products require highly demanding environmental conditions to ensure compliance with sector-specific GMP (Good Manufacturing Practices), in addition to pharmaceutical regulations. The process is based on the ability to build segregated aseptic environments (ISOLATORS) where processes can take place under Grade A of cleanliness, according to the existing pharma and most recent ATMP regulations. One of the challenging points is the integration of unconventional devices, quite different from the configurations which apply in the chemical pharma industry, needed for specific operations to be performed on cells (heaters, incubators, refrigerators, freezers, centrifuges et cetera). Peculiar requirements involve the ability to make the machine-friendly, easy to use, stable, safe for product and operator, cost-effective in time, and labour management.
Dealing with a new application or an existing application and a different manufacturing approach is always challenging for both the customer and the manufacturer.
The initial phases of a new project involve a focus on preliminary analysis, sales engineering, and mock-up. In some cases, the exercise is simple (the scope of the project is well defined and
the URS already in place and complete in full). In other cases (complex/multi-tasking projects, important technology transfers, need for additional business case studies) the concepts outlined here can be an independent project and they can also be individually sold. The detailed design phase relies on a multidisciplinary team, where different skills and expertise are put together in order to address the full range of possible issues of the project and identifying the best solutions for each of them.
The continuous challenges posed by the incoming new applications and the progress of technology drives Comecer to a constant renewal of our isolator solutions for ATMP.
Find it all in our ATMP Catalogue, fill in the form to request your copy!
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