Cleaning validation & cross-contamination

Cleaning validation & cross-contamination

HPAPI Cleaning Validation Strategy

  • Cleaning validation based on PDE / HBEL approach
  • Scientific worst-case selection
  • Highly sensitive analytical methods for residue detection (ex. LC-MS)
  • Validated cleaning procedures for:
  • equipment
  • isolators
  • auxiliary systems/tools

We control cross-contamination risk through proven, GMP-driven methodologies.

They are our core.

LET'S CONNECT

Our excellent team will be happy to conncect

CONTACT US