In order to ensure that the food
and pharmaceutical products we intake comply with the specification for
microbial quality, microbial testing is necessary. For all the products that are being
manufactured for the consumption of human being, their production involves a
number of considerations to make sure that the sample or the product is safe
for the use.
Another step is to determine for
how long the product is ideal/safe to be used which basically implies that its
original nature or the composition is not changed or affected as a result of
time and temperature changes. The safety of the product is ensured through
various testing procedures to find out whether the contamination is within the
safe limits and standards.
Standards and their Specifications…
There have been created many
standards with the aim to guard the production as well as the patrons by
preventing the release of the products that are not suitable for use.
One such standard is USP (United
States Pharmacopeia) chapter 61 also known as the Microbial Limits Test. MLT is
likely to be carried under specified conditions to avoid any accidental
microbial contamination. The standard provides commands for the evaluation of
the amount of feasible aerobic microorganisms that could be present in the non-sterile
product.
The guidelines mainly include
testing for the Plate Count (TPC) which includes the Aerobic Plate Count (APC)
and also the Yeast/Mold Count (YMC). Besides it also included screening and
detection for certain said microorganisms. This standard is also equivalent to
the Microbial Limit Test (MLT) of Japanese Pharmacopoeia.
To be able to provide the
standards not only for the US but for the entire world and since majority of
the USP standards are similar to that of European Pharmacopeia, there was a
course of harmonization being settled upon which as result was initiated and
made authorized in May, 2009.
