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

GMP Cleanroom

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.

GMP Cleanroom Walls

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.

GMP Cleanroom Floors

(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

GMP Cleanroom Doors And Windows

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.

GMP Cleanroom Requirements For Health Products

(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.

Level Of Airborne Particulate Cleanliness In Prefab Cleanrooms

Specification Table

Why Choose Us

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.

• Establishment & Vision: Guangzhou Cleanroom Construction Co., Ltd. was founded in 2010 and is committed to becoming a one-stop cleanroom construction and solutions partner for customers, contributing to the development of the global cleanroom industry.
• ​Qualifications and Honors: It is a high-quality enterprise in China's cleanroom system engineering and equipment manufacturing industry, and has been recognized as a high-tech enterprise and a "little giant" of technological innovation in Guangzhou, demonstrating its leading position in the industry.
• Base Locations: The company has a rational layout, with its production base located in Panyu, Guangzhou, and its sales center in Pazhou, Guangzhou. The two locations operate in coordination, ensuring efficient production of products and quick response to market demands, providing convenient services to customers. We warmly welcome customers from home and abroad to visit us.
• Localized Services: In the process of global development, the company attaches great importance to localized services and has established stable partnerships in many countries such as Indonesia, Saudi Arabia, and the Philippines. This layout ensures that we can provide local customers with timely on-site responses, tailored solutions, and efficient after-sales services, allowing customers to experience seamless support.
• Certifications and Patents: The company has passed multiple international certifications such as ISO 9001, ISO 14001, and ISO 45001, and owns numerous utility model patents and design patents, reflecting its strict quality management and strong research and development capabilities. It is also a member of many professional associations such as the Guangdong Laboratory Association and the Shanghai Laboratory Equipment Association, and actively participates in well-known industry exhibitions such as the National Hospital Construction Conference and the Munich Shanghai Analysis & Biochemistry Exhibition, always keeping pace with the industry frontier.
• Product Applications: The company focuses on providing comprehensive solutions for laboratory and medical cleanroom construction. Its products include air showers, pass boxes, workbenches, dissection tables, fume hoods, etc., which are widely used in various fields such as animal experiments, biosafety, food safety, chemical industry, semiconductors, healthcare, and pharmaceuticals.
• Customer Cases: With high-quality products and services, it has won the trust of many well-known institutions such as Nanshan Pharmaceutical, Sun Yat-sen University, Tsinghua University, Hong Kong University of Science and Technology, Guangdong Medical Device Quality Supervision and Inspection Institute, and Shenzhen CDC.