The Client:
Quantum Specials Ltd is dedicated to providing a comprehensive range of
high quality, commonly used pharmaceutical specials including; oral
solutions and suspensions, pastes, creams and ointments, unit dose
powders, capsules, reefers and suppositories.
Location:
Burnopfield, County Durham, U.K.
Project Scope:
Establish a microbiological environmental monitoring programme for clean
room manufacturing areas and provide ongoing analytical support
services.
Project Duration:
Ongoing
The Project
Quantum Specials initially appointed the Honeyman Group to develop their
existing cleaning validation programme. The successful completion of
this project subsequently lead to Honeyman being awarded the contract
for the cleaning validation and disinfectant efficacy testing for the
two new clean rooms. Since then, Honeyman have developed an
environmental monitoring programme for their clean manufacturing areas
at their facility in the North East of England and carry out the
on-going, routine analysis of environmental monitoring samples.
Marion Hetherington, Senior Product
Management Technician at Quantum Specials explained why they turned to
the Honeyman Group, “The Honeyman Group have an excellent reputation for
providing first class, GMP compliant analytical services; just as
important however, is their ability to produce clear, concise and
compliant supporting documentation and report formatting”.
In order to develop an appropriate
microbiological environmental monitoring programme, an initial on-site
review of both wet, dry and product contact areas was carried out to
evaluate existing monitoring procedures. Following this, the protocol
and sampling plan were prepared and ‘action’ and ‘alert’ levels defined
based upon the findings and recommendations of the review.
Various monitoring techniques were
adopted including the use of contact plates for the monitoring of
surfaces, settle plates to enable air quality monitoring and swabs for
the sampling of irregularly shaped articles and ‘hard to reach’ areas.
Also included in the package was a training session for staff at Quantum
Specials focussing on; the future identification of critical points,
defining the frequency and quantity of sample points, choice of media
and surface swabbing techniques.
Once the monitoring schedule had begun
the samples were sent to the Honeyman Group’s MHRA approved laboratory
in Barnard Castle for incubation, analysis and reporting. In the event
of OOS results, the Honeyman Group’s team of Analysts are always on hand
to provide dedicated support in the interpretation of results and
troubleshooting measures.
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