Basic Info.
Product Description
GMP stands for "Good Manufacturing Practice", which is the globally accepted standard of regulations for pharmacy, medical device, and certain food manufacturing set forth by the FDA (Food & Drug Administration). Therefore, cleanrooms that adhere to GMP standards are a must for pharmacy 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.
GMP requires a cleanroom or clean area for pharmaceutical manufacturing. Within the GMP there are further standards for the materials used in the construction of a cleanroom or area compliant with GMP. All materials must be able to withstand frequent cleaning and disinfection. Additionally, materials must be free of cracks, smooth and level, and able to interlock seamlessly. Particulate materials may not be used due to the risk of contamination. Aside from GMP compliance, other factors such as durability, ease of installation, and cost come into consideration when designing a cleanroom. At E-Clean we will guide you through the design process step by step to ensure that both GMP standards, your needs, and your budget are all satisfied.
| Product Name | Food Industry Modular Cleanroom | |
| Options | 1. Pass box 2. Air shower 3. ULPA filter 4. Sticky mats 5. Barometer 6. Gowning area 7. Pressure different control device 8. Transparent/grid PVC curtain 9. Thermo-static and humid-static air conditioning system. | |
| Partition | Rock wool sandwich panel, EPS panel, Hollow glass megnesium sandwich panel, etc | |
| Suspended ceiling | Rock wool sandwich panel, Hollow glass megnesium sandwich panel, T-Grid ceiling, etc | |
| Floor | Anti static PVC tile | |
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