SPECIALIZING IN CCI TESTING & METHOD DEVELOPMENT

Introduction to the Laboratory

We operate in full compliance with EU GMP, CNAS, and CMA quality management system requirements, and have successfully passed the European Union Qualified Person (QP) audit.

 

Through long-term collaboration with FDA-recognized core technology suppliers for CCIT instrumentation and leading independent testing facilities, we have accumulated deep practical expertise in CCIT methodologies.

 

Remaining true to our founding mission, the laboratory is dedicated to supporting global clients in navigating regulatory submissions and inspections by authorities including the FDA, EMA, WHO, PIC/S and NMPA. We are fully committed to advancing the international pharmaceutical industry through technical excellence and regulatory integrity.

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  Standard setting ability

  Deeply participate in the drafting and compilation of national standards for the pharmaceutical industry, and consolidate the technical accumulation of industry norms.

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  Authoritative research and development of pharmacopoeia

  Assist in the research and compilation of the draft of the Chinese Pharmacopoeia 2025, with pharmacopoeia level research and development capabilities.

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  Deep cultivation of professional monographs

  Take the lead in promoting the compilation of CCIT monographs and delve into specialized technical research in specific fields.

CCI Test Methods

• Vacuum Decay

• Pressure Decay

• Headspace Gas Analysis

• Helium Leak Detection

• High Voltage Leak Detection

• Airborne Ultrasound

• Residual Seal Force

• Dye Ingress Test

• Bubble Emission

• Microbial Ingress Test

Service Content

• 01

  

  Package Development & Verification

  Package System Development (Material Selection, Vendor Qualification, Dimensional Control)

  Package Closure Component Compatibility Testing (per USP <382>)

  Package Integrity Verification for Manufacturing & Assembly Processes

• 02

  Commercial Manufacturing

  Selection & Optimization of Critical Sealing Parameters for Process Control

  Re-evaluation of Package Integrity Post-Material/Component Change

  Package Seal Quality Testing

  Nitrogen Purging Process Validation

  Lyophilization Process Validation (with CCIT)

  Glove Integrity Testing

  Batch Release Testing

  Vacuum Level Verification

  Stopper Pop-up/Deflection Testing

  Headspace Gas Analysis (O₂, CO₂, Pressure)

  Capping Process Validation

• 03

  Stability Studies

  Package Integrity Over Product Shelf Life

  Verification Against Integrity Challenges During Storage, Transport & Distribution

  CCIT Validation for Low-Temperature Processes (e.g., freeze-thaw, cold chain)