Facility Development
Facility Development for GMP & ISO-Compliant Medical Device Manufacturing Setup
Site Identification
We assist in identifying and evaluating suitable locations for establishing medical device or healthcare manufacturing facilities. Our assessment includes considerations of regulatory zoning, infrastructure, utility availability, proximity to logistics hubs, and long-term scalability, ensuring alignment with project goals and statutory compliance.
Obtaining Statutory Approvals
Navigating local and national regulatory bodies is complex. We manage the entire statutory approval process, including obtaining licenses from bodies such as the Pollution Control Board, Fire Department, Municipal Authorities, and CDSCO, ensuring the facility meets legal and environmental compliance requirements.
Facility Layout Design in AutoCAD
Our engineering team develops detailed facility layout drawings using AutoCAD, tailored to ISO 14644 cleanroom standards and GMP requirements. The layout is optimized for material flow, contamination control, utility management, and future expansion, forming the structural blueprint for regulatory submissions and construction.
AHU Design (Air Handling Unit)
We design AHU systems critical to cleanroom functionality. Our approach includes defining filtration stages (pre, fine, and HEPA), airflow patterns, differential pressure management, temperature/humidity control, and ducting strategy. Designs meet ISO 14644 and NABL norms for sterile and semi-sterile environments.
ISO Cleanroom Development
We support the construction and commissioning of ISO-classified cleanrooms (ISO 5, 6, 7, and 8) suitable for sterile manufacturing, diagnostics, and packaging. This includes material selection (PUF panels, epoxy flooring), access control, pass boxes, and integration with environmental monitoring systems, adhering to ISO 14644-1 standards.
Process Validation (Sterilization, Men-Material Movement)
We design and validate key processes such as sterilization (autoclave, EO, gamma), gowning procedures, and controlled men-material movement workflows to ensure contamination control. Documentation and execution are aligned with GMP and ISO 13485 standards, supporting routine audits and compliance inspections.
Building Management System (BMS) Integration
We offer consulting for BMS integration to control HVAC, lighting, security, and critical utility systems. BMS integration ensures real-time monitoring, energy efficiency, alarm management, and regulatory documentation. Our expertise spans platforms compliant with 21 CFR Part 11 for audit trail requirements.
Facility Validation Document Development
We prepare a comprehensive suite of validation documents including URS (User Requirement Specification), DQ/IQ/OQ/PQ protocols, HVAC qualification reports, and validation master plans. These documents are essential for CDSCO, US FDA, and EU regulatory inspections.
Simulation Lab Setup for Medical Colleges (as per NMC)
We provide turnkey solutions for setting up advanced clinical simulation labs in alignment with National Medical Commission (NMC) guidelines. Our service includes space planning, equipment procurement, installation, and SOP development for skill-based training of medical students.