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 laboratoryReview of practices for adequacy and appropriatenessCollaboration with client in investigation of repeat environmental monitoring failures, water failures and products failuresSTERILITY ASSURANCE:Creation of best aseptic processing procedures / Clean room disciplinesRisk assessments (Sterile Product Compliance Risk Assessment) to determine the enhancements in legacy aseptic manufacturing facilitiesMaterial transfer to clean areasAseptic intervention executionManagement and revisiting of interventions to establish robust media fill designComprehensive Aseptic Processing Risk Assessment – Materials, Practices, Procedures, Design, Products attributesTrainings – Clean room Behaviour, Environmental Monitoring program, Gowning practices, Cleaning and Disinfection, Sterilization etc.Aseptic Process Simulation (Media Fill) design and oversightMedia Fill Failure investigations