Plant Design & PMC Services
Setting up a medical device manufacturing facility requires specialized cleanroom layouts. Cleanrooms must meet strict ISO Class classifications (Class 5, 7, or 8) with proper HVAC systems, pressure differentials, and material/people flow designs to pass CDSCO inspections. We provide full project management from blueprint design to final cleanroom validation.
Key Benefits
- 100% SLA/CLA compliant plant layouts
- Prevents costly reconstruction mistakes due to bad layouts
- Validated cleanrooms ready for sterile packaging
Recognized Standards
Our Methodology
Concept Layout
Draft initial layout defining zoning (sterile, core, washing, warehouse).
HVAC & Cleanroom Setup
Design air handling units (AHU) and particulate controls.
Validation
Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Required Documents
Common Questions
Related Regulatory Insights
Navigating the New CDSCO Medical Device Regulations: A Definitive Compliance Guide
Understand the regulatory shift under India's Medical Device Rules (MDR) 2017, classification pathways, and MD-15 import licensing requirements for global manufacturers.
The MD-42 Trade License: Selling Medical Devices in India
A breakdown of the MD-42 wholesale registration requirements for distributors, importers, and traders operating in India.
Need Assistance with Plant Design & PMC Services?
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