Microbial load fell within the predefined limit, suggesting contamination was controlled during a single time point.
Microorganism proliferation on dirty equipment in a class D manufacturing facility was managed during a hold time of 96 hours, a bioburden study shows.
The low variability indicated consistent contamination control performance, the author wrote.
While a key part of the cleaning validation process, the dirty-hold time study is “typically overlooked”.
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.
The following equipment were assessed:
- saizoner mixer granulator
- fluidized bed dryer (FBD)
- binder preparation vessel
- square bin
- mesh
- tablet compression machine
- colloid mill
- coating suspension vessel
- blister packing machine.
Amlodipine tablets were selected because its main excipients, starch and microcrystalline cellulose, are an “excellent growth medium for microbial growth and proliferation”.
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 °C and a humidity less than 60 percent.
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.
[The study showed] a total aerobic microbial count and total yeast and mould count below 100 cfu/25cm2”
Standard deviation of total aerobic microbial count was 20.61 and total yeast and mould count 0.44 observed, respectively.
Contributing factors could be the “controlled environment, low water activity on surface of equipment’s or low nutrient viability”, the author suggested.
Further multi-time point studies are needed to establish hold time justification, they noted.
The paper was published in the Journal of Clinical Pharmacology and Pharmacotherapeutics.
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