Simplifying Set-Up of Clean Processing Facilities
Navigating the highly regulated world of medical manufacturing and clean room operations can be a daunting, time-consuming task. Regulations and standards, developed by such organizations as the U.S. Food & Drug Administration, the International Organization for Standardization (ISO) and others, are many and complex.
But understanding the regulatory requirements is only the first hurdle to overcome. Special attention needs to be given to not only your cleanroom but to the cleanliness, calibration, maintenance, and record-keeping of your processing equipment.
Learn more about:
- The most common standards governing the manufacturing, processing, and packing of plastics medical devices
- The different levels of cleanrooms
- How machines that are factory calibrated to meet regulatory requirements can deliver peace of mind