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Following a series of transportation trials to
determine the viability of transporting microbiological samples over long
distances, the Honeyman Group are now offering clients across Ireland a full
range of analytical services.
The Honeyman Group’s Analytical Services
Laboratory teamed up with their client, a global pharmaceutical manufacturer for the
transportation trials following the completion of a water system distribution
loop project at the Southern Ireland site by the Honeyman Group.
Honeyman were initially engaged by the client to design, engineer and project manage a new water system
distribution loop project for the secondary and bulk production facility. Part
of this project included Honeyman taking responsibility for the quality
management of the water system, including the preparation of the Performance
Qualification (PQ) rationale & protocols and compilation of the PQ summary
reports.
The Honeyman Analytical Services Department
devised and executed a fully visible audit trail, which included the preparation
of PQ documentation, water analysis and individual summary report preparation
for each PQ phase as well as the preparation of an overall consolidated summary
report.
A major challenge encountered during this
project encompassed the geographical position of the manufacturing facility, the
distance to the Honeyman laboratories in
the North East of England and the associated transportation of the water samples
by road and air and the effects that
transportation would have on the microbiology of the water samples. As such, a
series of transportation trials were performed prior to the commencement of the
PQ phase using the manufacturing facility as the delivery/return point.
The trials were performed over a 48-hour period
to represent the ‘worst case’ scenario of samples being delivered to the
Honeyman laboratories out with the 24 hour required period. The packaging used
during the trials achieved and maintained temperatures between 2 and 8°C
over a 48-hour period and therefore complied with the United States Pharmacopeia
(USP30 <1231>) guidelines.
Transportation of the samples appeared to have
a minimal effect on the microbiological population and in general, results
indicated a slight growth, rather than loss, of organisms in the samples. In
the event of samples being delayed during the transportation process, the
results obtained would present a “worst-case” scenario of the total viable count
in the samples rather than a potential false indication of reduced numbers (or
absence) of organisms. |
