Low Acid validation for GEA Procomac ABF

| Filling & Aseptic | GEA Procomac | Sala Baganza (Parma)

GEA Procomac is proud to announce that its revolutionary machine ABF (Aseptic Blow Fill) has successfully passed the LA (Low Acid) microbiological validation and is suitable to fill milk and milk based products.

GEA Procomac is proud to announce that its revolutionary machine ABF (Aseptic Blow Fill) has successfully passed the LA (Low Acid) microbiological validation and is suitable to fill milk and milk based products.

The GEA Procomac ABF is a unique machine that sterilizes the preforms and directly blows them in a sterile blower.
ABF consists in a traditional oven, a preform sterilizer, a sterile blower and an aseptic filler. 
The preforms are warmed up in the oven and they arrive already hot in the preforms sterilizer, where they are covered by a flow of Hydrogen Peroxide that sterilizes them internally and externally. Once they are sterile they enter in the sterile area of the blower, are stretch-blown into bottles and are then filled in an aseptic filler.
The sterile blower environment is inside a Microbiological Isolator and is maintained with an overpressure of sterile air. The sterile blower is sterilized by means of Hydrogen Peroxide, but of course not only the environment of the Microbiological Isolator has to be sterilized, even all the high/low pressure pipelines that bring the sterile blowing air to each single mould are sterilized.

GEA Procomac has designed a special stretch rod system.
During the operation of a standard stretch rod, it moves up and down in a non-sterile environment entering the moulds and touching the preform/bottle. 
We designed a stretch rod system with a magnetic joint allowing it to be moved inside the aseptic housing. This allows the stretch rod to remain sterile following the sterilization with Hydrogen Peroxide.

This machine is unique because it sterilizes preforms instead of bottles.
Preforms are much thicker and heat resistant than bottles and once they are blown they are already sterile with no further need to stress them with a sterilization process. The saving in terms of PET is clear, due to the possibility to lightweight bottles further.

ABF has now been validated in Low Acid (LA) conditions, validations necessary to fill products with a PH > 4,5
The Low Acid validation was structured in order to challenge the decontamination capabilities of the machine in different crucial areas:

  • It has been done in the Aseptic Blower environment and internal pipelines inoculating the Biological Indicator Bacillus atrophaeus ATCC 9372 in a spot and performing up to 6 log reductions
    The importance of having a sterile environment after the preforms are sterilized is evident, only a sterile environment can assure that they won’t be re contaminated again before being filled.
     
  • The Low Acid validation has been done on preforms internal and external surfaces inoculating Bacillus atrophaeus ATCC 9372 and performing up to 6 log reduction
    Key feature of the ABF is the simultaneous internal and external sterilization treatment of the preforms, with no risk of cross contamination.
     
  • A production test with Culture Broth was carried out on 3 batches of 10.000 bottles with a result of zero defective bottles on the 30.000 produced. A very good result if we consider that the standard on the market for this kind of tests is a max 1:10.000 defected bottles per batch.
    Culture Broth test is especially studied to enhance the growth of specific microorganisms that could grow in a LA product. This test offers clues on every single step of the aseptic machine, telling us if the containers were properly sterilized, if the environment was properly sterilized and kept in sterility at the right overpressure inside the Microbiological Isolator.

GEA Procomac Aseptic Blow Fill has passed all the steps to be suitable to produce LA products:

 MicrorganismKind of inoculumLog reduction
Preform externalBacillus atrophaeus
ATCC 9372
Spot inoculumup to 6 log reduction
Preform internalBacillus atrophaeus
ATCC 9372
Spot inoculumup to 6 log reduction
Blower
environment
Bacillus atrophaeus
ATCC 9372
Spot inoculumup to 6 log reduction
Blower internalBacillus atrophaeus
ATCC 9372
Spot inoculumup to 6 log reduction

Culture Broth Test LA - max 1:10.000 on 30.000 bottles




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