GMP-COMPLIANT CLEANROOM DESIGN AND CONSTRUCTION
GMP cleanrooms are among the leading standards used today to evaluate cleanroom quality. So what do you know about this standard, and which companies specialize in providing reputable GMP-compliant cleanroom design and construction services? Today, we will answer these questions in the following article.
As you may know, in cleanroom design, construction, and installation services, many standards must be met to ensure cleanliness, such as the latest ISO 14644-1:2015 and ISO 14644-2:2015 standards. However, depending on the industry such as pharmaceuticals, electronics, or food processing - there are additional standards like GMP that must be followed during cleanroom design, construction, and installation to ensure suitability for the specific products manufactured in that cleanroom.
What is the GMP cleanroom standard?
A room or area is considered GMP-compliant when environmental factors are strictly controlled at optimal levels. Among these, airborne particle concentration is the most important factor in assessing the cleanliness of a room.
According to international GMP cleanroom regulations, airborne particles must be below 5 µm. GMP cleanrooms are classified into four grades, each with different allowable particle concentration limits. In addition, other factors used to assess GMP compliance include temperature, humidity, pressure, and air change rates. Specifically:
- Temperature: ≤ 25°C
- Humidity: ≤ 70%
- Pressure: from 2 to 33 Pa (depending on the cleanroom grade)
- Air changes: ≥ 20 times/hour
These parameters are established alongside other control measures to ensure proper cleanliness levels.
Applications of GMP cleanrooms
GMP cleanrooms are widely applied across various sectors of daily life:
In the medical field
They ensure that airborne particle levels remain at the lowest possible level, eliminate nearly all bacteria, and maintain environmental air conditions that are comfortable for humans. This helps protect patient health during treatment and prevents cross-infection between patients. Especially in operating rooms, GMP-compliant cleanrooms play a critical role in preventing post-surgical infections.
In storage and preservation technology
Pharmaceuticals, food products, cosmetics, and similar items require strict conditions to prevent deterioration and maintain quality for end users. Thanks to their capabilities, GMP cleanrooms are indispensable in storage and preservation areas. Cold storage facilities, supermarkets, and warehouses are locations that require cleanroom construction meeting this standard. Moreover, combining cleanrooms with cleanroom panel systems, electrical and power systems, HVAC systems, and air conditioning systems helps ensure smooth production processes and enhanced safety.
In manufacturing
Even a tiny airborne particle entering the production process - especially in electronic manufacturing and microchip production - can cause defects or damage to products. Therefore, ensuring that manufacturing processes are not affected by environmental factors makes GMP-compliant cleanrooms extremely important. Additionally, in production lines for sterile pharmaceutical packaging, oral medications, or topical drugs for non-open wounds, packaging materials must be cleaned (washed, sterilized, dried, etc.), which also requires GMP-standard cleanrooms.
Criteria for GMP cleanroom construction
- Dust particle levels must comply with permitted limits.
- Particle sizes range from 0.1 µm to 5 µm.
- Materials brought into the cleanroom must be handled using appropriate cleanroom pass boxes.
- Microbial levels must remain within allowable limits.
- All machinery and equipment used in the cleanroom must be thoroughly sterilized before operation.
Viet Panel Company specializes in the design and construction of cleanrooms for pharmaceutical factories, medical device manufacturing, packaging, food processing, electronics, and more - meeting GMP standards as well as WHO, HACCP, and ISO standards. With the goal of aligning Vietnam’s industries with the most advanced international technologies and placing customers at the center, all clients who work with us are highly satisfied with our product and service quality. How about you?
If you are in need of GMP cleanroom design or cleanroom equipment, please contact our hotline at +84 2226 535 699 / +84 984 050 786 for consultation and to experience our outstanding products and services.
