Qualiculture

Phama Biotech Services

MICROBIOLOGY AND STERILITY ASSURANCE:

QualiCulture provides the following expert services in the area of Microbiology and Sterility Assurance.

MICROBIOLOGY:
Systemic evaluation of Microbiology laboratory
Review of practices for adequacy and appropriateness
Collaboration with client in investigation of repeat environmental monitoring failures, water failures and products failures
STERILITY ASSURANCE:
Creation of best aseptic processing procedures / Clean room disciplines
Risk assessments (Sterile Product Compliance Risk Assessment) to determine the enhancements in legacy aseptic manufacturing facilities
Material transfer to clean areas
Aseptic intervention execution
Management and revisiting of interventions to establish robust media fill design
Comprehensive Aseptic Processing Risk Assessment – Materials, Practices, Procedures, Design, Products attributes
Trainings – Clean room Behaviour, Environmental Monitoring program, Gowning practices, Cleaning and Disinfection, Sterilization etc.
Aseptic Process Simulation (Media Fill) design and oversight
Media Fill Failure investigations