Factory Pharmaceutical Line Design

Design Your Own Pharmaceutical Factory

We design, configure and optimize pharmaceutical production lines based on the specific needs, product characteristics, regulatory requirements, and future expansion plans of pharmaceutical manufacturers to provide services or solutions that meet specific pharmaceutical production and quality control requirements.

Factory pharmaceutical line design service

1. Why is Customized Pharmaceutical Production Line Necessary?

The pharmaceutical industry has stringent regulatory requirements, complex processes, and diverse product types, often making standardized production lines inadequate for meeting individual enterprise needs.

1. Customized Pharmaceutical Production Lines Can:

Comply with GMP (Good Manufacturing Practice) requirements.

Meet regional drug production regulations (e.g., FDA, EMA, NMPA).

Support specialized environmental needs, such as sterile production, isolation systems, and cleanroom classifications.

2. Adapt to Specific Drug Production Processes:

Different drugs (e.g., tablets, injectables, biologics, herbal extracts) require tailored equipment and process layouts due to significant variations in production workflows.

3. Enhance Efficiency and Product Quality:

Optimized equipment combinations, automation, and material flow will reduce human intervention and improve product consistency.

4. Enable Small-Batch, Multi-Product Production:

Our equipment meets modern pharmaceutical demands for flexible manufacturing and rapid product switching (e.g., clinical trial drugs, specialty medicines).

Future-proof expansion or upgrades: Custom designs allow for modular interfaces, facilitating future capacity increases or technology integration.

2. What does pharmaceutical production line customization include?

1. Process Design and Workflow Planning

Design end-to-end production processes based on drug characteristics (chemical, biological, traditional medicines).

Plan material/personnel flows and cleanroom zoning to ensure GMP compliance and prevent cross-contamination.

2. Equipment Selection and Configuration

Customize or select critical equipment for specific processing needs, such as:

Solid Dosage: Mixers, granulators, tablet presses, coaters.

Liquid Dosage: Batching systems, filling lines, sterilizers.

Biologics: Bioreactors, centrifuges, chromatography systems.

Customization ensures that materials, surface finishes, and cleaning validation will meet pharmaceutical standards.

3. Automation and Digital System Integration

PLC/SCADA: Equipment synchronization and automated control.

MES (Manufacturing Execution System): Manage production scheduling, execution, and traceability.

Data Analytics: Real-time monitoring, SPC (Statistical Process Control), and quality tracking.

Electronic Batch Records (EBR): Compliance with 21 CFR Part 11 and other e-record regulations.

4. Cleanroom and Facility Design

You can choose cleanliness levels (e.g., ISO Class 5/7/8) based on product risk, as well as HVAC, air filtration, pressure differentials, and segregated personnel/material pathways.

5. Validation and Compliance Support

We will execute DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

We will also assist with GMP documentation, audit preparation, and regulatory inspections.