PHARMA CLEAN To Tell You What The GMP Cleanroom Is
In recent years, cleanroom system has been paid attention to by more and more industries, such as pharmaceutical, biotechnology, electronics, semiconductors and aviation. Clean rooms play an irrevocable role in the manufacturing process, such as improving production efficiency, ensuring product quality, improving employee health, and reducing environmental pollution.
When we talk about clean rooms, we often see GMP Cleanroom. But many people don't know what it means. Today we will introduce what is the GMP Cleanroom.
The full name of GMP is Good Manufacturing Practice. It is a standard requirement for the control of quality to ensure that the parameters of the cleanroom must be under control, most of which are used in the medical and pharmaceutical industries.
The main goal of GMP standards remains is to minimize the risks of microbiological, particulate contamination during preparation and sterilization of medicines or medical devices. This helps ensure that products are of consistent high quality, are appropriate for their intended use, and meet the requirements of product specifications.
Among the cleanroom standards we have seen, the most common are GMP standards and ISO standards. About ISO standards, we have discussed before, what is the difference between GMP standards and ISO standards?
The first difference is the field of application. ISO standards are usually used in a variety of industries, pharmaceutical, food, herbal, cosmetic, electronics factory and chemical plants. The GMP standard is mainly used in the medical and pharmaceutical fields.
The second difference is that the ISO standard distinguishes nine "CLASSES", while the GMP standard distinguishes four "GRADE".
Grade A is the highest level of the best GMP standards, it indicates that the work area has high risk and must be maintained at high level of quality control. Grade A is equal to ISO Class 5 clean room.
Grade B is the aseptic area for making, proportioning, filling. Grade B is equal ISO Class 5 at rest and ISO Class 7 cleanroom in operation.
Grade C is low grade operation area of low importance during operation. Grade C is equal to ISO Class 7 at rest and ISO Class 8 in operation.
Grade D is low grade operation area of low importance during operation too. Grade D is equal to ISO Class 8 cleanroom.
Therefore, cleanroom that adhere to GMP standards are a must for drug and medical device manufacturers. Suzhou Pharma as being pioneers of Cleanroom Turnkey Project, our projects comply with GMP requirements，and we provide excellent products and reliable service for various industries around the world.
Suzhou Pharma Machinery Co.,Ltd.
2023/12/29
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