The document describes how a pharmaceutical company almost scrapped a $0.5 million batch of product after bioburden testing found a potential pathogenic bacteria. An investigation team performed a root cause analysis and reexamined the original culture and gram stain under a microscope. It was concluded that the laboratory made an error and the bacterium was actually a non-pathogenic gram positive bacilli that had stained gram negative. Reculturing and additional tests confirmed this, preventing the batch from being scrapped and saving the company $0.5 million.

1. JuneYamadaConsulting: “Transforming Operations to New Heights!” July2013
CASE STUDY
What You See Under the Microscopic can be Deceiving
How I Prevented a $0.5 Million Batch of Product from being Scrapped!!
Before releasing a lot of a microbial-controlled pharmaceutical, bioburden testing is performed
to determine the type(s) and quantities of microorganisms within the product.
While working at a pharmaceutical manufacturer, the bioburden test results of a lot of product
appeared to include a potential pathogenic bacterial species; thus, the general consensus was
to reject/scrap the lot. An investigation team was formed and root cause analysis was
performed using the Ishikawa Fishbone Diagram as a tool:
Potential Pathogen
in Bulk
Material Method
Man Machine
Purified Water
Raw Materials
Bulk Sample Retest
Gram Stain
SOPs
Mfg Tech Error
Lab Tech Error
Cleaned Mixer
Cleaning Validations
Before/after batches
At risk?
Environment
EM Excursions?
Cleaned/
sanitized?
As part of the root cause exercise, I re-examined the culture and original gram stain under the
microscope…concluded the laboratory made an error. The bacterium was not a potential gram
negativepathogen but a non-pathogenic gram positive bacilli that stained gram negative--- the
deceit! Somegram positive bacteria can stain gram negative. When in doubt, reculture, restain,
run other tests toconfirm. This observation prevented the batch from being scrapped, saving the
company $0.5 Million!