Pharmaceutical & cGMP Labs

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Solution Details

Common Testing Items

Dissolution testing

Content uniformity analysis

Microbial limit testing

Sterility testing

Particle size analysis

Stability indicating methods

Laboratory Function Areas

Temperature control is set at 20±2°C for QC labs, with monitoring systems for compliance documentation.

Humidity is maintained at 45-55% for optimal product stability. Classified clean areas range from ISO 5 to ISO 8 depending on process requirements.

Separate gowning rooms and material airlocks are provided, with differential pressure monitoring between zones.

Key Points Of The Planning

Regulatory compliance with FDA, EMA, and other relevant guidelines

Data integrity through controlled access and audit trails

Change control provisions for future modifications

Service Content

Laboratory Design:

cGMP-compliant layout, cleanroom classification planning, material and personnel flow optimization, stability chamber room design

Laboratory Construction:

Validated HVAC systems, cleanroom finishes, purified water systems, controlled temperature storage areas

Laboratory Furniture Configuration:

Stainless steel work surfaces, pass-through autoclaves, sampling booths, stability chambers, HPLC systems, dissolution testers

Service Process

Project Initiation Support

Site Selection

Drawing Design

Construction

Furniture Configuration

Cleaning and Acceptance

Project Completion

Warranty Service