API production Modular Cleanroom

Modular Structure Core Design Considerations

1. Material Compliance

●Wall Panels: Antibacterial color steel sandwich panels or stainless steel panels are used, with smooth, non-porous surfaces that withstand acid and alkali cleaning and disinfectant wiping, meeting GMP requirements for materials that are free from peeling and contamination.

●Flooring: Epoxy self-leveling or polyurethane flooring is used, seamless and wear-resistant, resistant to solvents and acid/alkali corrosion in API production, while meeting anti-static requirements (resistance value 1×10⁶-1×10⁹Ω).

●Sealing: All joints and pipe penetrations are sealed with medical-grade sealant to prevent dust accumulation and microbial growth, meeting the airtightness requirements for aseptic production.

2. Airflow and Environmental Control

●Airflow Organization: The aseptic API production area uses vertical unidirectional airflow with an airflow velocity of 0.45±0.1m/s to ensure clean air coverage of the core operating area; non-aseptic areas use a top-supply, bottom-return turbulent flow pattern, balancing cleanliness and energy consumption.

●Temperature and Humidity Control: Temperature is maintained at 20-24℃, and humidity at 45-60%RH to prevent raw materials from absorbing moisture, clumping, or degrading, while ensuring personnel comfort.

●Pressure Difference Gradient: Strictly adhere to the pressure difference requirement of "clean area > semi-clean area > non-clean area." The pressure difference between clean and non-clean areas should be ≥10Pa, and the pressure difference between different clean areas should be ≥5Pa to prevent cross-contamination.

3. Personnel/Materials Channel Design

●Personnel Channel: A three-level purification process is set up, including changing rooms, air showers, and handwashing and disinfection rooms. The air shower velocity is ≥20m/s, and the air shower time is ≥15 seconds to ensure that personnel remove surface dust before entering the clean area.

●Materials Channel: Equipped with pass-through windows or material buffer rooms. Sterile raw materials must enter the production area through a VHP sterilization and transfer system to avoid introducing contaminants. Different batches of materials are stored separately to prevent batch mixing.

Core Advantages and Industry Adaptability

1. Rapid and Compliant Production Deployment: Modular components are prefabricated in the factory, reducing on-site assembly time by more than 50% compared to traditional civil engineering. Pre-testing can be completed before delivery, ensuring rapid GMP certification and meeting the rapid expansion needs of API (Active Pharmaceutical Ingredient) companies.

2. Flexible Adaptation to Process Changes: The number of modules can be flexibly increased or decreased, or the internal layout adjusted (e.g., adding isolated operating rooms or drying rooms), according to API production processes, without large-scale dismantling and modification, reducing process upgrade costs.

3. Easy Cleaning and Maintenance: The seamless structural design and corrosion-resistant materials facilitate daily cleaning, disinfection, and equipment maintenance, reducing production downtime and adapting to the continuous production requirements of APIs.

Commonly used equipment in cleanrooms