Preform: Preforms do in general have a good hygiene level depending on storage conditions. With GMP it is easy to keep the hygiene of the preform at a level below 10 cfu/preform as a mean value. The absolute maximum shall not be above 50 cfu/preform. The complete preform is checked. Sampling point is at the infeed to the blow-moulding machine.
Bottle: Bottles do in general have a good hygiene level depending on storage conditions of the preforms and on the hygiene of the blow-moulding machine. With GMP it is easy to keep the hygiene of the bottle at a level below 20 cfu/bottle as a mean value. The absolute maximum shall not be above 100 cfu/bottle. Ideally the complete bottle is checked. If only the inside is checked, 10 cfu/bottle and 50cfu/bottle apply. Sampling point is at the infeed to the bottle steriliser.
Flat caps: For flat caps an initial bioburden of below 10 cfu/cap as a mean value is acceptable. The absolute maximum shall not be above 50 cfu/cap. Sampling point is at the infeed to the cap steriliser.
Chemically sterilisable sports caps: For these sports caps an initial bioburden of below 10 cfu/cap as a mean value is acceptable. The absolute maximum shall not be above 50 cfu/cap. Only the reachable parts of the surfaces are checked. Sampling point is at the infeed to the cap steriliser.
Non chemically sterilisable sports caps: For these sports caps pre-irradiation is required. The treatment has to ensure commercial sterility and food safety requirements. The physical performance of the cap must not be affected. Sampling point is at the infeed to the sorter
Test Spores
Spores of Bacillus atrophaeus ATCC 9372 are recommended for PAA and H2O2 systems. More used for Low Acid products and surface decontamination trials.
Spores of Aspergillus niger ATCC 16404 are recommended for PAA, H2O2 and UV-light systems. Mostly used as the mould reference in the industry. More dedicated for High Acid products.
