![\"Background](\"https:\/\/www.newsbeep.com\/il\/wp-content\/uploads\/2026\/04\/20365_shutterstock_2525550239_116298.jpg\")
<\/p>\n<\/p>\n
Microorganism proliferation on dirty equipment in a class D manufacturing facility was managed during a hold time of 96 hours, a bioburden study shows.<\/p>\n
The low variability indicated consistent contamination control performance, the author wrote.<\/p>\n
While a key part of the cleaning validation process, the dirty-hold time study is \u201ctypically overlooked\u201d.<\/p>\n
In an environmental monitoring area at the non-sterile facility, samples were taken from difficult-to-clean areas on nine different pieces of equipment used to manufacture amlodipine tablets 5mg.<\/p>\n
The following equipment were assessed:<\/p>\n
\nsaizoner mixer granulator
\nfluidized bed dryer (FBD)
\nbinder preparation vessel
\nsquare bin
\nmesh
\ntablet compression machine
\ncolloid mill
\ncoating suspension vessel
\nblister packing machine.
<\/p>\n
Amlodipine tablets were selected because its main excipients, starch and microcrystalline cellulose, are an \u201cexcellent growth medium for microbial growth and proliferation\u201d.<\/p>\n
They set a predefined microbial limit of 100 cfu\/25cm2. A total of 18 unidirectional samples were conducted, as two samples were taken from each piece of equipment. The locations during sampling were maintained below 25 \u00b0C and a humidity less than 60 percent.<\/p>\n
The author anticipated the dirty equipment would show a high microbial load. However, they observed a total aerobic microbial count and total yeast and mould count below 100 cfu\/25cm2. Fungal load was found also very low compared to the bacterial load.<\/p>\n
<\/p>\n
[The study showed] a total aerobic microbial count and total yeast and mould count below 100 cfu\/25cm2\u201d<\/p>\n
<\/p>\n
Standard deviation of total aerobic microbial count was 20.61 and total yeast and mould count 0.44 observed, respectively.<\/p>\n
Contributing factors could be the \u201ccontrolled environment, low water activity on surface of equipment\u2019s or low nutrient viability\u201d, the author suggested.<\/p>\n
Further multi-time point studies are needed to establish hold time justification, they noted.<\/p>\n