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How we can help you

Analytical Testing

  • Chemical Analysis
  • Microbiological Analysis
  • Environmental Monitoring
  • USP Water Testing
  • Microbial Identification

    • Validation Services

  • HVAC / Clean Room Validation
  • Sterilization Development & Validation
  • Water Systems Validation

    • Consulting Services

  • Custom Projects
  • Medical Device Performance Testing
  • Out of Specification Investigations

    • Chemical Analysis Tests Method
    Physicochemical Analysis
    Plastics & Elastomers    		 USP
    Water Testing USP / EP
    Total Organic Carbon USP
    Gas Chromatography
    FID    		 USP
    FT-IR USP / ATR
    UV / VIS Spectrophotometric Analysis USP
    HPLC: Diode Array, Refractive Index USP
    PH USP
    Specific Conductivity USP
    Arsenic USP I & II
    Heavy Metals USP I & II
    Loss on Drying USP
    Residue on Ignition USP
    Liquid Particle Count: SVP/LVP
    Electronic    		 USP
    Stability Studies USP / ICH
    Moisture / Water USP
    Raw Materials Analysis
    Monograph    		 USP / ACS / EP
    Osmolality USP
    Oxygen
    Headspace    		 USP
    Microbiological Analysis Tests Method
    Environmental Monitoring
    Surfaces    		 RODAC
    Environmental Monitoring
    Air    		 SAS
    Non-Viable Particle Counting ISO 14644-1
    Disinfectant Evaluation FDA / CDRH
    Microbial Limits Test USP / EP <61, 62>
    Bioburden
    Aerobic / Anaerobic / Spore    		 USP / BAM
    Bioburden
    Water    		 USP / APHA
    Bioburden
    Water Coliform    		 APHA
    Bioburden
    E. coli    		 AOAC / MPN
    Bacterial / Yeast Identification
    Genus or Species    		 MIDI / VITEK / Crystal / Riboprinter
    Bacteriostasis / Fungistasis USP
    Fungal Identification BIOLOG
    Perservative Effectiveness
    AME    		 USP / CTFA / EP
    Growth Promotion USP / EP
    Spore Strip Population Verification USP
    Spore Strip Species ID MIDI / Vitek / Riboprinter
    Packaging Challenge Testing
    Microbial Ingress    		 Immersion
    Endotoxin
    LAL    		 Kinetic Chomogenic / Kinetic Turbidimetric
    Autoclave Validation, Cycle Development USP
    Environmental Monitoring Method
    Airborne Particle Testing ISO 14644-1
    HEPA Filter Leak Testing IEST-RP-CC 006.2
    Air Velocity Measurements
    HEPA Filters    		 IEST-RP-CC 006.2
    Air Volume Change Rate Testing IEST-RP-CC 006.2
    Clean Room Pressurization Testing IEST-RP-CC 006.2
    Makeup Air Volume Testing IEST-RP-CC 006.2
    Unidirectional Airflow Parallelism Testing IEST-RP-CC 006.2
    Temperature / Humidity / Dew Point Testing IEST-RP-CC 006.2
    Viable Microbiological Testing
    Air and Surfaces    		 USP <1116>
    Microbial Identification Midi / Vitek / Crystal / Riboprinter
    USP Water Testing Method
    Total Organic Carbon USP <643>
    Conductivity USP <645>
    pH USP <791>
    Oxidizable Substances EP Monograph
    Chlorides / Nitrates / Sulfates EP Monograph
    Ammonium / Calcium / Magnesium EP Monograph
    Heavy Metals EP Monograph
    Residue on Evaporation EP Monograph
    Trace Chlorine ISE
    APHA 4500-CI-I
    Trace Silica APHA 4500-Si D&E
    Resistivity USP
    Total Dissolved Solids APHA
    Heterotrophic Plate Count USP <1231> / APHA 9215 D
    Total Coliform Test APHA 9222 B
    Endotoxin
    Kinetic Chromogenic / Turbidimetric    		 USP <85>
    Organism Isolation APHA 9225 B
    Gram Stain APHA 9221 B, 3, 4
    Bacterial Identification MIDI / Vitek / Crystal / Riboprinter
    Fungal Identification BIOLOG

    Microbial Identification

    • Fatty Acid Analysis (MIDI)
    • VITEK Analysis
    • Crystal Analysis
    • Organism Isolation
    • Gram Stain / Morphology
    • Fungal Identification Capability (BIOLOG)
    • Anaerobe Capability
    • Trending Service

    HVAC / Clean Room Validation

    • Preparation of IQ / OQ / PQ Protocols
    • Viable Microbiology Monitoring (air and surfaces)
    • Non-Viable Monitoring (particles)
    • On-Site Sampling (So. CA Only)
    • Orgnism Identification (MIDI / VITEK / Crystal / Riboprinter)
    • Cleaning Validation
    • Disinfectant Testing
    • Clean Room Certification Fed Std. 209E/ISO 14644 Compliant

      • The following are clean room / workstation testing and certification options fully implemented by QSI.

    • Airborne Particle Testing - Fed Std. 209E
    • Airborne Particle Testing - ISO 14644-1
    • HEPA Filter Leak Testing
    • Air Velocity Measurements (HEPA Filter)
    • Air Volume Change Rate Testing
    • Clean Room Pressurization Testing
    • Makeup Air Volume TEsting
    • Unidirectional Airflow Parallelism Testing
    • Temperature / Humidity / Dew Point Testing
    • Viable Microbiological Testing (air and surfaces)
    • Microbiological Identification
    • Surface Disinfection Validation
    • Cleaning Validation
    • On-Site Sampling Service

    Sterilization Development & Validation

    • Laboratory capabilities for prototype evaluations (bench testing)
    • Experience with steam, ETO, Gamma, e-beam, and dry heat
    • Full analytical laboratory support
    • Novel methods: UV, Gas Plasma, H2O2, Laser
    • Disinfectant testing capabilities (air and surfaces)
    • On-Site sterilizer qualification (temperature mapping / BI cycles)
    • Sterilization validation protocol preparation and execution to support FDA marketing applications

    Water Systems Validation

    • WFI (USP), Purified (USP), European Pharmacopeia Monographs, and Laboratory Grade testing
    • IQ / OQ / PQ Protocol development with on-site execution of protocols (So. CA only)
    • Laboratory support provided (chemistry and microbiology),
    • Online Total Organic carbon (TOC) vs. discrete testing validation
    • TOC systems suitability validation
    • Same day laboratory testing initiation service

    Certifications