2.8m Height GMP CE Class 8 Clean Rooms ISO4 Sterile For Health Products

GMP standard Class 8 Modular clean room 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.

GMP Cleanroom Construction Materials

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.

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 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 panel.

GMP Cleanroom Technical Specifications

GMP classifies cleanrooms/clean areas into four levels: A, B, C, and D. These levels relate to how effective the cleanroom/clean area prevents contamination of the manufacturing and/or processing environment by dust particles and microorganisms. The four levels also have set ranges for temperature control and air pressure control, as well as lighting and noise levels.

Level A: High-priority or high-risk areas such as filling areas, bottling areas and packaging areas. Laminar flow hoods are often used in A-level areas in order to avoid turbulent air flow, which increases risk of contamination. Level A areas must maintain uniform air flow at a speed of between 0.36 - 0.54 m/s.

Level B: Level B cleanrooms/clean areas are common in sterile configuration areas and filling areas, as well as in background areas adjacent to A-level areas.

Levels C & D: Levels C and D are common in lower risk areas throughout the manufacturing and packaging process that do not have cleanliness standards as stringent as those in levels A and B.

What can anlaitech GMP Cleanroom do for your Company?

(1) Our many years of experience providing cleanroom solutions for the pharmaceutical industry have provided us deep insight into meeting our clients' needs and budgets, while also designing and constructing facilities that meet the highest international standards.

(2) We prioritize energy savings in order to reduce your future operating costs.

(3) We can design cleanroom solutions to meet any international standard, including ISO14644, FS209E, IEST and EN1822.

(4) We don't just do cleanrooms. We take into account your entire operation--from the flow of people to facility logistics the ventilation system--in order to ensure that your enterprise executes at maximum efficiency.

(5) We can design, install and test every aspect of your purification system. We also educate you on how to maintain your cleanrooms and equpiment to ensure future compliance with relevant standards.