With Ziebaq, we offer a full cleanroom validation package, from planning and designing to building and setting up, as well as making procedure documents and confirming the cleanroom. Our cleanroom validation package will make sure that your cleanroom meets ISO 14644 or EU GMP standards. We also always work with our customers to make sure that the acceptance factors are perfect for them. Every part of the cleanroom approval process needs to meet certain standards for us to be happy with the result. You can be sure that your cleanroom will be safe for years to come because we can make cleanroom validation contracts that are good for a long time and set up regular site visits.
We can help you test and validate your cleanroom here at Ziebaq so that it is ready for review. With more than a decade of knowledge, we provide a variety of services, including:ss
One of the most essential parts of making sure GMP compliance is testing and validating the airflow in the cleanroom. It's hard for most pharmaceutical businesses to get the particle classification grade they need. The following tests are done by our team using equipment that has been set to meet industry standards (ISO 14644-3):
In order to properly qualify cleanroom performance, ISO 14644-3:2019 "Cleanroom Test Methods" lists a number of "supportive tests." These tests were called "optional tests" in the 2005 version of the ISO 14644-3 standard.
As the names suggest, these tests are "supportive" or "optional." For a good cleanroom validation, you should only do the ones that meet your needs. This is because the ISO 14644 series is for all fields that use cleanrooms and other controlled settings. For instance, electrostatic tests are very important in the chip and microelectronics industries, but they are optional in paint shops for cars that have controlled conditions. Airflow viewing is an important part of making sure that air flows in only one way on sterile production lines in the pharmaceutical industry.
The government requires certain industries, such as pharmaceutical, medical device, and USP797 compounding shops, to work in clean rooms and produce items in a sterile setting.
Companies that make medical devices and medicines need clean surroundings to produce their goods. Cleanrooms provide a pure, ultra-clean environment, making it less likely that contamination will get into medicines.
Cleanrooms are used for manufacturing processes that need to be very clean and germ-free. Medical gadgets, drugs, and semiconductors are all common uses of cleanrooms.
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