Sometime back a sterile manufacturing firm was audited and the
regulators found deviations in the ET standard limits for different loads.
All of us are aware that ET is the “period which elapses between the
attainment of the sterilization temperature at the reference measuring point and
the attainment of the sterilization temperature at all points within the
sterilization load” EN ISO 17665-1:2006.
It was very important for the firm to meet the ET standard limits to
make sure the following were achieved-
To achieve the same the firm
decided to replace the autoclave that was 7-years old as a corrective step subsequent
to an internal meeting.
While the team started discussing with autoclave suppliers and
manufacturers they faced the dilemma of tackling challenges with changes and
alteration.
Seeking alternates to replacements team VienniTM undertook
a gap audit, gap assessment and analysis and provided solutions for
optimization with revised cycle parameter yielding firm phenomenal savings of a
variety.
Team VienniTM took 4 working days to
execute this project, ranging from helping the firm to optimize resources which
was a permanent solution.
Three successful validation runs were conducted
and all met the acceptance criteria for critical parameters including ET.
Now, the firm continues to
successfully manufacture the batches without any regulatory hurdle of
Equilibration Time.
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