USP 797 Pharma Cleanroom in Bangladesh
Tailored for a local small-to-medium pharmaceutical factory in Dhaka, Bangladesh, this project is customized to address local production conditions, climate challenges, and compliance standards. Local environmental factors in Bangladesh—such as persistent high temperature, high humidity, and high levels of ambient dust—frequently cause conventional civil-built cleanrooms to suffer from dust accumulation, mold growth, poor airtightness, lengthy construction cycles, and failed compliance inspections. Designed in strict accordance with the USP 797 international pharmaceutical cleanroom standard, this 22m² ISO Class 7 modular cleanroom perfectly matches the operational and regulatory requirements for local aseptic drug compounding, raw material pre-treatment, and sterility testing.
Project Highlights
1. Prefabricated Modular Assembly Tailored for Overseas Remote Construction
Addressing common local challenges in Bangladesh—such as limited technical expertise among local construction teams, incomplete civil infrastructure, and low on-site efficiency—the project utilized a fully prefabricated modular design. The aluminum alloy structural frame, fire-retardant sandwich wall panels, and purification accessories were completely prefabricated, pre-assembled, and tested in our domestic factory before export. This eliminated complex on-site cutting, welding, and painting overseas. The structure requires only simple assembly on-site without complex ceiling renovations, significantly shortening construction timelines, preventing air leakage and dust traps caused by substandard local workmanship, and providing a durable, airtight environment suited to the local hot and humid climate.
2. Aligned with International Standards to Meet Local Pharmaceutical Compliance
As the pharmaceutical industry in Bangladesh aligns with international cleanroom standards, regulatory requirements for sterile production continue to rise. Through precise system commissioning, the indoor cleanliness of this cleanroom consistently meets ISO Class 7 (Class 10,000) standards, fully complying with USP 797 cleanroom standards. The system effectively intercepts outdoor dust, airborne particulates, and microorganisms to maintain a stable aseptic environment. This solves local contamination issues caused by dusty ambient conditions and satisfies production standards for drug compounding, aseptic sampling, and raw material processing, helping the client export compliant products.
3. Three-Zone Independent Smart Control System for Precise Overseas Operations
To match overseas operational habits and site needs, the cleanroom is divided into three independent functional zones. Each zone is equipped with a dedicated control panel supporting independent adjustments for FFU purification air speeds and lighting levels. Unlike traditional uniform-operation systems, zoned control allows flexible adjustments based on personnel density and usage frequency. This adapts well to local grid conditions, effectively lowering energy consumption and operational costs. Additionally, high-precision differential pressure gauges continuously monitor indoor positive pressure 24/7, preventing outdoor dust and high-humidity air from backflowing into the cleanroom.
4. Scientific Three-Zone Layout to Eliminate Cross-Contamination
Following standard industry procedures for "step-by-step purification and separation of personnel and material flows," the layout features three distinct functional areas: a dirty-zone changing room, a clean-zone changing room, and the main cleanroom. To resolve issues with improper worker operations and mixed flow paths, physical partitions strictly isolate personnel entry routes from material transport routes. This multi-stage protection approach prevents cross-contamination at the hardware level, standardizing workflows to meet local pharmaceutical manufacturing requirements.
5. Integrated Cleanroom Accessories Optimized for Overseas Material Handling
Given frequent material transfer operations and poor outdoor air quality in Bangladesh, opening doors repeatedly would compromise the indoor clean environment. A dedicated clean pass box was installed between the dirty-zone changing room and the main cleanroom, enabling sterile material transfer without opening the main doors and minimizing air disturbance. Furthermore, automatic sliding doors between the clean zone and main work area offer contact-free entry and space savings, fitting local operational habits while safeguarding the sterile interior environment.
6. Human-Centric Details Tailored for Long-Term Operation
Several details were optimized for overseas maintenance and daily operations:
Sealed Tempered Glass Observation Windows: Installed in wall panels, these offer airtight performance and allow routine inspection without frequent door opening, minimizing contamination risks.
Custom Electrical Outlets: Planned according to the client’s pharmaceutical equipment layout and local electrical standards, these custom sockets support various production and lab devices, eliminating messy external wiring and electrical hazards for long-term production operations.