The design of the API pharma area and powder processing area is carried out with careful attention to detail, ensuring full compliance with ISO Class 8 and Class D standards, in alignment with WHO and USFDA guidelines. Our conceptual layout accommodates more than 50 critical design requisites to achieve a fully GMP-compliant facility.

A key principle of our design approach is maintaining unidirectional flow for both man and material movement. This ensures controlled circulation within the pharma area, effectively preventing contamination and cross-contamination during all stages of processing.

We meticulously define and size all processing areas — including crystallization, filtration, drying, milling and sifting, blending, packing, labelling, quarantine, and other supporting spaces — based on equipment dimensions, operational workflow, and the smooth movement of personnel and materials. Each area is optimized for functionality while strictly adhering to safety and quality standards.

The design also covers well-planned entries and exits for the pharma area. This includes designated man entry points, packing material entry, solid material and liquid material entry points, finished goods exits, and emergency exits. All these are carefully integrated with required door interlocks and pass boxes to ensure safe and contamination-free transitions between different areas.

Furthermore, we define the locations for electrical cable entry, duct entry, utility connections, and drainage systems within the pharma area while ensuring these elements are enclosed and isolated from atmospheric exposure. This design approach safeguards the sterile environment and operational hygiene of the facility.

Finally, we prepare comprehensive pharma area drawings that fully adhere to GMP guidelines. These drawings are accompanied by detailed site plans, which are submitted to the State FDA authority to facilitate timely review and secure the necessary primary approvals for the project.