Aluminum Profile GMP Cleanroom with 0.45 m/S ISO Class 8 for Pharmaceutical Use

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 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.

Cleanroom walls and ceilings should be bright and clean, fade resistant, smooth and even, and easy to clean. Common materials for cleanroom walls include stone, Choi steel, and Terrazzo, which are often coated in a special paint. For especially damp production environments that are difficult to keep clean, Vitrolite (porcelain) walls may be used. However, in this case it is crucial that the material is applied evenly and sealed with no cracks to minimize the risk of contamination. We recommend Choi steel and/or paint coating for best results.

1. Cleanroom floors are required to be smooth and level, scratch resistant, impact resistant, easy to clean, high integrity, and free of cracks. In addition, GMP cleanroom floors must be anti-static and possess sufficient weight bearing capacity.
2. Cleanroom floors must be moisture resistant. To achieve this, install a buffer layer below the concrete foundation layer and use an elevated floor.
3. Approved floor surface coatings: a) Inelastic Surface - Terrazzo / b) Painted Surface (film) - acrylic, epoxy, polyurethane; self-leveling - self-leveling epoxy resin / c) Elastic Facing Material - PVC Plastic Flooring

Doors used in cleanrooms must be smooth and even, easy to clean, of simple design (no door sill), and must open in the direction or the cleanest area that they connect. Cleanroom doors must be sealed when not in use to preserve the positive pressure environment. In order to avoid mold and deformation, wooden doors should never be used in clean areas or cleanrooms.

Windows in cleanrooms should be smooth and even, of simple design, resistant to dust collection, and installed flush with interior walls (no windowsill). Cleanroom windows should not be made of wood. Windows installed between clean areas and non-clean areas should consist of at least two layers, with at least one of those layers being a non-moveable pane.

1. An appropriate air quality and temperature control system must be installed according to the type of health product being manufactured and the proximate environment.
2. The manufacture and packaging of pills, tablets, caplets, soft capsules, powders, medicinal teas, pastes and related products should abide by the guidelines set forth in GMP for D level cleanrooms. The manufacturer may further optimize the manufacturing and packaging environment and facilities depending on the exact nature of the product.

Gcc is one of the leaders in modular cleanrooms industry that can provide you with the most cost-effective cleanroom solutions according to your require or give you professional advice.