— Expertise
Facility Design
Proper design of sterile production facilities assures functional needs and regulatory Regulatory compliance — it is essential for efficient operation and obtaining regulatory approvals smoothly.
Layout Design
Optimized spatial arrangement of production suites, supporting rooms, airlocks, gowning areas, and technical spaces — designed for operational efficiency and contamination prevention.
Flow Planning
Rigorous separation and planning of material flows, operator flows, and waste flows — eliminating cross-contamination risks and meeting GMP requirements for unidirectional movement.
Pressure Cascades & Airflows
Engineering of differential pressure regimes between classified zones, ensuring airflow direction always protects the product from contamination — critical for aseptic processing areas.
Clean Room Classification
Design specifications for Grade A (ISO 5), Grade B (ISO 7), Grade C (ISO 8), and Grade D areas — including at-rest and in-operation particle count requirements and environmental monitoring strategies.
Materials & Construction
Specification of wall systems, flooring, ceilings, doors, pass-throughs, and surface finishes — ensuring cleanability, durability, and compliance with pharmaceutical construction standards.
Regulatory Compliance by Design
Every design decision is evaluated against FDA, EMA, and Annex 1 requirements from the earliest conceptual stage — preventing costly redesigns during qualification or regulatory inspection.
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Conceptual Design
Requirements gathering, URS, process flow definition
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Conceptual Design
Requirements gathering, URS, process flow definition
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Conceptual Design
Requirements gathering, URS, process flow definition
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Conceptual Design
Requirements gathering, URS, process flow definition
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Conceptual Design
Requirements gathering, URS, process flow definition
