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Cleanrooms, GMPs and ISO Certification
Recent successes in cell and immune-mediated therapies have accelerated the possibilities for cell-based therapies as a mainstream form of treatment across the globe.
As stem cell research and regenerative medicine continue to gain clinical importance, the need for reproducibility, reliability and contamination-free performance of basic laboratory equipment is essential to the quality process.
As stem cell research and regenerative medicine continue to gain clinical importance, the need for reproducibility, reliability and contamination-free performance of basic laboratory equipment is essential to the quality process.
Laboratories and other settings that work with biologically relevant products require a clean and controlled environment to establish and maintain sample integrity.
Contamination events cost both time and resources, leading to significant delays in research, as well as patients' ability to receive the therapeutic treatments.
Contamination events cost both time and resources, leading to significant delays in research, as well as patients' ability to receive the therapeutic treatments.
In order to prevent such a situation, this Application Note will explain how to set up a clean room that complies with GMP and ISO standards, which are considered to be effective in preventing contamination.
Threats to Cell Culture-Based Product Production
What is a Cleanroom Classification
Who Needs an ISO-Certified Cleanroom?
Cleanroom Certified Equipment
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