Aseptic Process Authority and Validation Services

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Aseptic Process Authority - Validation Services | JBT FoodTech

JBT provides advanced world-wide process authority and validation services in support of aseptic processing and filling technologies. Services include compliance/regulatory audits, aseptic thermal process design, validation of low-acid aseptic filler technologies, and complete FDA-product filing support.

JBT's team of experienced scientists and laboratories can microbiologically validate a wide array of filler packaging material sterilization technologies. Our proprietary AseptiCAL software enables unparalleled optimization of aseptic thermal process design, to include the accurate modeling of aseptic low acid particulate product thermal processes required for the FDA-filing of these products.


Validation Services for:

JBT aseptic systems (low-acid or acid/acidified foods)

  • AsepTec® Linear Fillers
  • AsepFlex Linear Pouch Fillers
  • Bulk fillers
  • Sterilizers, aseptic tanks

Non-JBT aseptic and ESL filling equipment (low-acid or acid/acidified foods)

  • Bottle, pouch, bulk, paperboard formats
  • Peroxide, PAA, peroxide-hybrid, steam-mediated technologies
  • Microfiltration "cold sterilization"
  • ESL applications (in support of FSMA)
  • Sterilizers, aseptic tanks

Validations/Verifications

  • Automation/Dynamic Audits
    • 21 CFR 11
    • Critical factor challenge machine response
  • Maintenance of Sterility Testing
  • Tetra Pak AQP (Red Book) Audits

Pasteurization technologies

  • Nut/low/intermediate moisture foods/high-moisture foods

Other Aseptic/ESL Process Authority Services

  • Compliance audits, troubleshooting
  • Process design and optimization, product/process assessments
  • System compliance review
  • Facility audits (21 CFR 108, 113, 117), Quality Systems, Microbiological Program audits
  • Process Design Support
  • Low Acid UHT Processes (particulate and non-particulate)
  • Other processes (acid / acidified foods, ESL)
  • Deviation Analysis
  • Filing support (deviation analysis and filing support can be offered as yearly service package)
  • Troubleshooting
  • Cause of Spoilage Investigations
  • Training (Thermal process, BPCS, Aseptic)

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