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Proactive Disclosure
Appendix A
Volumes 1-3
January 1993
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Definition of Terms
- Lot: A batch or production unit which may be identified by the same code. When there is no code identification, a lot may be considered as (a) that quantity of product produced under essentially the same conditions, at the same establishment and representing no more than one day's production; or, (b) the quantity of the same kind of product from one and the same manufacturer available for sampling at a fixed location.
- Sample: The sample units taken per lot for analysis.
- Sample Unit: Usually a consumer size container of the product, and should consist of a minimum of 100 g (ml), unless stipulated in the method.
- Analytical Unit: That amount of product withdrawn from the sample unit for analysis.
- HGMF Count: Is the number obtained when counting either those HGMF grid-cells which contain colonies or those which do not. Counts may be made over the whole HGMF, or a central portion (one-fifth) of the HGMF.
- HGMF Score: Is the total number of HGMF grid-cells containing colonies. It may equal the HGMF count, or be derived from this by multiplication and/or subtraction operations, as necessary.
- Most Probable Number of Growth Units (MPNGU): On HGMF the Growth Unit (GU) is equivalent to the more familiar Colony Forming Unit (CFU). The MPNGU is derived from the HGMF score by an equation (Appendix B - 1.2.).