Table 2 – Protocols
(Methods) for Microbial
Dipstick 1 1
USP* 3 2
Plate Count** 7 9
Enrichment*** 2 3
Rapid Method**** - 3
*United States Pharmacopeia 61 Microbiological
Examination of Nonsterile Products: Microbial
**Trypticase soy agar, Cetrimide, Sabouraud,
MacConkey and Potato dextrose agars
Letheen, Tetrathionate, Lauryl tryptose, Modified
tween letheen and “MLAT” broths.
**** Celsis, Bactometer, “ATP.”
Methods included plate counts, the most
frequently reported, as well as enrichment
methods and in a few cases, rapid methods.
A variety of general and selective media
were reportedly used. For microbial limits,
respondents were asked:
• If raw materials or finished products
are tested against a specification for total
count, what are the specific numerical
Table 3 – Cleaning and
Conducting this Activity
eliminate the microbial contamination.
These findings often provoke more frequent
testing of raw materials and finished products. In addition, microbiological testing of
the manufacturing process/environment
may be implemented to determine and mitigate the root cause of the contamination.
The survey responses indicate that many
manufacturers/suppliers within the household products and related industries have
validated cleaning/sanitization processes.
Even though the methods vary, there clearly
is a general understanding of the importance of manufacturing“plant” hygiene on
product quality. One aspect of a hygiene
program, such as continuous microbiological
monitoring of the process equipment, seems
to be well understood and is generally utilized for assessing microbiological hygiene
within the manufacturing environment.
Questions were included to assess the
current state of process cleaning and sanitization (C&S) practices within the manufacturing facility. The respondents indicated
that the majority of manufacturers understand the importance of both cleaning and
sanitization. The main focus of C&S appears to be on the mixing and filling
processes. Of the 13 company responses,
12 indicated some level of cleaning of the
filling line equipment and flexible hoses,
while 13 indicated sanitization of this
equipment. Refer to Table 3 for a list and