Design and construction of GMP-ISO cleanrooms, including cleanrooms of levels A, B, C, D

Before proceeding with the construction of the cleanroom system, it is necessary to develop the following technical drawings:

The structure of the cleanroom includes the following parts:

1. Epoxy or vinyl flooring: Typically, epoxy flooring is used for cleanrooms in pharmaceutical, nutraceutical, cosmetics, food, medical equipment, and healthcare industries, while vinyl flooring is common in operating rooms. The floor should be smooth, seamless, bright in color, waterproof, and free of gaps.

2. Ceiling and wall panels: Smooth panels with rounded corners at junctions. Ceiling and wall panels come in various types and costs, allowing customers to choose according to their requirements.

3. HVAC system: Air Handling Units (AHU), Air Conditioning Units (ACU), electrical control panels, ductwork, air vents, supply and return air grilles, and filters (Hepa H13, G4, F8). The HVAC system helps control temperature, humidity, particle count, and microorganism levels in GMP cleanroom environments.

4. Cleanroom equipment: Pass boxes, air showers, etc., used as transfer devices between different areas.

5. Lighting fixtures and electrical systems: Recessed electrical wiring.

6. Other supporting systems: Reverse Osmosis (RO) system, compressed air system, fire protection system, floor drainage system, wastewater treatment system. Note: Supporting systems' products must also meet cleanliness requirements corresponding to the cleanroom level before being introduced into the environment.

Controlled factors in GMP cleanrooms include:

Temperature: 23 ± 3 oC

Humidity: Typically < 65%. In some cases, such as the production of health supplements like effervescent tablets and softgel capsules, stricter humidity requirements may apply (e.g., humidity < 30%).

Pressure differentials

Particle count: According to the four cleanliness levels in GMP.

Microorganisms: According to the four cleanliness levels in GMP.

Air velocity

Airflow direction

Air exchange rate: Higher cleanliness levels require higher air exchange rates.

The design and construction process for GMP-ISO cleanrooms typically involves the following steps:

1. Receive project information from the client.

2. Conduct on-site surveys.

3. Design M&E (Mechanical & Electrical) drawings. For clients without technological layout drawings, GMP-EU will develop production layout drawings according to GMP-ISO standards. After finalizing the production layout drawings, detailed M&E drawings will be created for construction.

4. Provide detailed quotations.

5. Finalize contracts and proceed with construction according to agreed materials and schedule.

BETA - Consultancy and construction of GMP and ISO cleanrooms:

Deep expertise in cleanroom solutions, from technical proposals to GMP-compliant construction.

Fast construction progress, meeting strict requirements for both time and quality.

Construction is checked and evaluated according to the Japanese quality management system.

BETA has its own factory for manufacturing ductwork and cleanroom equipment, reducing construction costs.

BETA actively invests in manufacturing technology to ensure quality and control issues during production. Equipment is made from non-oxidizable materials to minimize operational issues.

Quick support for operation and repair of any issues encountered during operation.