The ISO 7 clean grade of cleanroom, is it means ISO certificate?

ISO 7 or class 10000 is clean room clean grade standard. it is not certificate. ISO 7 means 0.5 um particles quantity less than 352000 pc/m3, and matched class 10000 standard.

When the buyer build clean room and then it is a workshop, the buyer’s company apply to their local government for GMP certificate and then the government will have team to test the clean grade in workshop whether it is meet ISO 7 or class 10000. so they will check the particles according the air clean grade sheet.

What is GMP? Who will make the GMP certificate?

GMP means "general production process", it is for product production, not materials or clean room factory. The GMP is general manufacturing process, not only for the clean grade but also the production technical and workers work process checking. So our construction clean room is necessary items but not only item which the buyer should prepare for GMP certificate

For example, you are biscuit manufacture, the cleanroom supplier only give you materials for clean room and meet GMP standard ISO 7 panel, HVAC, floor, air shower pass box ,etc. Then the biscuit manufacturer need get GMP, if qualified then you get GMP workshop proof. This is workshop factory need to do rather than clean room manufacturer.

Our company Suzhou Pharma Machinery as the clean room manufacturer, we could supply the CE certificate of our products, such as clean room, led light, sandwich panels, filters, etc.

Normal document including commercial invoice, packing list, certificate of origin,etc.In some countries when they build the clean room, the local government require related certificate for clean room. So before the production buyer need to inform in advance what certificate will require. Then we will prepare or assist buyer to supply the documents.

Suzhou Pharma Machinery Co.,Ltd.

2023/03/20

Spencer