GEA Procomac has developed an aseptic filling technology for low acid sensitive beverages designed for FDA compliance. This aseptic concept uses PAA wet as sterilizing medium, microbiological isolator for environment control, complete bottle neck handling system and GEA Procomac Fillstar Fx volumetric electronic filler. These aseptic systems for PET containers are available for speeds in excess of 720 bottles per minute. 

Basics of PAA wet sterilization

  • Bottle sterilization with spraying of liquid peracetic acid (PAA) with bottles upside down; PAA solution is recovered and reused.
  • Bottle rinsing with spraying of sterile water (bottles upside down); rinsing water is recovered and reused.
  • Penetrating nozzles with high sterilizing solution flow rate.
  • Control of each process parameter: sterilizing solution and sterile water flow rate, concentration, temperatures and pressure.
  • Up to 6 log reduction on reference micro-organisms.

Specific features have been implemented for FDA compliance

  • Mechanical modifications made to add & validate further system redundancy:
    • redundant HEPA filters in sterile zone;
    • liquid barrier with sterilant solution at rotary seal.
  • Improved sterilization capabilities:
    • spray ball design spray nozzles;
    • modified bottle grippers.
  • Sterilization Process ugrades:
    • PAA-based sterilant development;
    • pathogen & Surrogate identification;
    • development of Sterilbag caps bags sterilization chamber for use with pre-sterilized gamma-irradiated caps.
  • FDA Validation Plan & Documentation ugrades:
    • GAMP / FPA 43-L Protocols
  • Data Management & Electronic Records ugrades:
    • 21CFR Part 11 Compliance

Advantages of aseptic PAA wet technology for PET bottles

Peracetic acid in liquid form offers many advantages compared to other sterilizing media such as H2O2 dry (hydrogen peroxide) when applied to PET bottles:

  • PAA wet is highly effective on Cold spot contamination.
  • Internal bottle sterilization is complemented by external bottle sterilization with spraying of the same liquid PAA solution to deliver log reduction of reference micro-organism based on customer requirements.
  • Internal and external sterilisation happen at the same time: no risk of cross-contamination between external and internal surfaces This leads to elimination of microbial load coming from outside the bloc: no intermediate CIP/SIP cycles required.
  • 120 continuous production hours guaranteed for High Acid, 72 continuous production hours guaranteed for Low Acid production.
  • Effectiveness of sterilization treatment is not constrained by preform type, or bottle weight.
  • Wet PAA solution is very effective also for line environmental sterilisation.
  • GEA Procomac can validate its sterilising procedure using any method of microbial load calculation and inoculum type.

PET bottle lightweighting opportunity

No limitations on the sterilising parameters:

  • The sterilising solution temperature is well below PET sustainability (65°C or less for low acid FDA applications).
  • Contact time: Short contact times are needed for PAA sterilization. It is possible to use bigger machine to upscale contact time and thus achieve higher sterilisation performance.
  • Bottle shrinkage is not an issue and very lightweight PET bottles can be treated adequately, also for low acid products.
  • Bottle handling with gripping starwheels and positive transfers can handle also very light bottles at very high speeds.

Peroxides residuals inside the bottles

  • GEA Procomac rinsing system complies with FDA requirements of less than 0.5 ppm inside the bottle.
  • PAA solution does not migrate into the PET molecule during sterilization and it is not released in the product afterwords.
  • It is well known that alternative sterilization procedures involving H2O2 might involve a migration of part of H2O2 into the PET matrix due to their molecular affinity.
  • Therefore, it is noteworthy to take this phenomenon ito account when determining the total level or residuals of PET bottles aseptically filled after H2O2 sterilization.