GMP stands for "Good Manufacturing Practice", which is the globally accepted standard of regulations for drug, medical device, and certain food manufacturing set forth by the American FDA (Food & Drug Administration). Therefore, cleanrooms that adhere to GMP standards are a must for drug and medical device manufactureres.
The GMP standards apply to the areas of starting materials, employee management, facilities and equipment, manufacturing processes, packaging, product quality, and complaint handling. The aim of these standards is to reduce contamination and increase quality of products critical to the health and safety of everyone. In order to accomplish these benchmarks, companies that produce these critical products must employ acceptable equpiment, a consistent manufacturing process, strict quality management, and constant process improvement. Our GMP Cleanrooms can help your enterprise meet the GMP standards by installing a state-of-the-art cleanroom solution that, when paired with an adequate management system, will minimize potential contaminants in your products.
| Brand |
Shenghua |
| Clean class |
ISO 8, Class 100-10000 |
| Noisy |
≤65dB (A) |
| HEPA |
Liquid trough sealing, 99.995%@0.3µm |
| Fan |
Imported centrifugal fan |
| Power |
220V, 50Hz, 1.0KW 220V, 50Hz, 2.0KW |
| Entrance |
PVC curtain or PC glass door |
| Control system |
Normal button or Touch screen |
| Average air speed |
0.36-0.54m/s |
| Remarks: All parts can be designed by your requirement |
We kindly needs following information to design your clean room
The structure parts:
1. Panel style:
Metal-face polyurethane core board,
Metal-face rockwool core board (widely used),
Metal-face polystyrene core board (without fire proof),
Metal-Face Honeycomb Core Board,
Metal-Face Plastered Core Board (widely used for ceiling),
Metal-face glass-magnesium core board.
Panel thickness: 50mm,70mm and 100mm
Panel Height: according to customer request
2. Door shape and window shape and quantities
3. Ornament material: circle 50 degree, 75 degree, alloy aluminum, silver color or painted color.
4. Layout drawings
5. The house structure: steel structure or ferroconcrete
Air conditioner and air fan parts
1. The technical height(the height between ceiling to girder lower point)
2. Air feeding duct and air sucking duct direction and arrangement
3. The clean grade request, temperature and humidity request, pressure balance request, wind speed request.
4. Air exhaust request and air exhaust quantity request
5. Workers quantity and equipments heat generating amount
6. Air conditioner or air fan brand and style request:
Water cooling or fan cooling?
Equipment parts:
1.The air shower room specification and material request.
2.The pass box specification and material, technical request.
3.Laminar flow specification and request
4.Weight room specification and request
5. FFU specification and request
Electricity Parts
1.Clean room illumination request, clean light style
2.Total power
3. Control style (full auto/manual)
4. Wire hidden style (pretreatment/hidden in sandwich board)
Floor parts:
1.The cement basic (the cement floor intension and flat degree)
2.Floor request (PVC/roller/plate static proof request, epoxy color)
Customized:we could according to your requirement to design for you.
Company information
Our Company is located in the beautiful seashore city, Qinhuangdao and is specialized in manufacturing pharmaceutical machinery and packing machinery. With an experienced and professional team, we have exported our products to many countries and regions all over the world, especially in North American countries and France, the Netherlands, Australia, India, Pakistan, Russia and many other countries and regions. Our products enjoy a good reputation among our customers. We welcome customers, business associations and friends from all parts of the world to contact us and seek cooperation for mutual benefits.
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