Contamination Test

Reduce The Risk
of Contamination With Compliance Driven Solutions

QSC provides "hands-on" expertise to evaluate site-specific operations in detail and works with user groups to implement compliant, pragmatic solutions.

Contamination Gloves

Compliance Consulting

Core Competencies Include:

Manufacturing Specialization: 

  • Aseptic Processing
  • Contamination Control
  • Environmental Control/Monitoring
  • Sterility Assurance
  • Bioburden Management
  • Isolator systems / RABS
  • Drugs
  • Biologics (small to large scale)
  • Tissue manufacturers
  • Bulk API
  • Medical Device manufacturers
  • ISO 5 -ISO 8 / Grade A-D Environments

Design, development and implementation of:

  • Aseptic training programs, operator qualification, and process simulation studies
  • Metrics and data trending to track the effectiveness of Contamination Control programs
  • Standards and requirements for Contamination Control, conducting gap analyses, creation of CAPA plans, SOP’s, OJT training
  • Comprehensive Cleaning and Disinfection programs for facilities and equipment
  • Environmental Monitoring (EM) Programs
    • Environmental Qualification (EQ) studies
    • Risk assessments, site selection, protocol development, data analysis, and reporting
    • Determination of routine EM programs
  • Mentoring of individuals across all departments and levels of the organization on contamination awareness and prevention.
  • Validation of aseptic processing methodologies, VHP decontamination, sterilization, and terminal sterilization cycle validation