GMP Pharmaceutical Modular Cleanrooms | Boben ISO Certified

Good Manufacturing Practice (GMP) is a mandatory global standard for the pharmaceutical, medical device, and cosmetics industries. Its core objective is to ensure that the entire production process—from raw materials to finished products—meets strict quality, safety, and hygiene requirements. As a critical infrastructure, the GMP Cleanroom is the essential pillar for achieving this goal, effectively minimizing the risk of microbial and particulate contamination during production.

In the field of cleanroom construction, Modular Cleanrooms are becoming the preferred choice for leading enterprises due to their speed, flexibility, high efficiency, and superior aesthetics. They are widely applied not only in industrial manufacturing but also in meeting the rigorous demands of biological cleanroom environments.

1. GMP Cleanrooms vs. Standard Industrial Cleanrooms

There are distinct differences between GMP-compliant cleanrooms and standard industrial cleanrooms:

• Classification Levels: GMP cleanrooms follow four specific grades: A, B, C, and D (corresponding to Class 100, Class 10,000, and Class 100,000). Standard industrial cleanrooms often utilize a broader range of ISO classifications.
• Contamination Control: GMP standards require control of both inanimate particles (dust) and animate microorganisms. In addition to particulate counts, testing must include sedimentation bacteria, planktonic bacteria, and surface microbial levels.
• Static vs. Dynamic Standards: GMP cleanrooms have different control standards for Static (at-rest) and Dynamic (in-operation) states. Static states serve as the benchmark for qualification and acceptance, while dynamic states are used for daily monitoring.

GMP Grade	ISO Equivalent	Inanimate Particles (At Rest)	Microorganisms (Active)	Typical Applications
Grade A	ISO 5 (Class 100)	≤ 3,520/m³	< 1 CFU/m³	Filling, Stopper bowls, Open ampoules
Grade B	ISO 5 (Class 100)	≤ 3,520/m³	<5 CFU/m³	Background zone for Grade A
Grade C	ISO7 (Class 10000)	≤ 3,52000/m³	< 100CFU/m³	Preparation of solutions, Filtering
Grade D	ISO 5 (Class 100000)	≤ 3,520000/m³	< 200CFU/m³	Handling of components after washing

2. Case Study: BOBEN GMP Modular Cleanrooms

This case study features a client located in a premier Biopharmaceutical Industrial Park across the Middle East and Southeast Asia. Home to numerous innovative enterprises and research institutions, the company chose BOBEN for its reputation in high-quality, intelligent cleanroom solutions, which perfectly align with their brand image and market positioning.

Project Specifications:

• Cleanliness Level: Grade C (Class 10,000)
• Functional Areas: Gown rooms (Stage 1 & 2), shoe changing areas, buffer zones, clean corridors, washing rooms, tool storage, and an extrusion workshop.
• Specialized Equipment: Equipped with Sterile Pass Boxes and Laminar Flow Pass Boxes for small item transfers, ensuring the production of high-precision medical extrusion products with tight tolerances.

The BOBEN Advantage：

During the construction phase, BOBEN GMP Modular Cleanrooms offer low noise and minimal pollution. Their high flexibility and strong customizability allow for a rapid response to personalized client needs. Furthermore, the sleek, transparent, and high-tech design breaks away from the rigid look of traditional cleanrooms. This modern aesthetic is ideal for corporate tours, technical exchanges, and exhibition scenarios. It not only ensures a stable and reliable production process but also serves as a powerful testament to an enterprise’s brand image and innovative strength.