Aseptic Process Authority and Validation Services

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
• 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)