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.

Design Process

1

Conceptual Design

Requirements gathering, URS, process flow definition

2

Basic Design

Layouts, P&IDs, equipment specifications

3

Detailed Design

Construction docs, vendor coordination

4

Construction Support

Oversight, change management, commissioning

5

Qualification

IQ/OQ/PQ, regulatory readiness