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| Advanced Contamination Control Technologies |
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| Air & Surface Microbial
Surveys |
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Often
key factors which greatly impact the microbiological quality within
a controlled environment remain undetected until a product, patient
or other critical operation has been adversely affected. Microbiological
sampling programs should be established to provide more than just
a microbial recovery level for comparison to statutory requirements.
If well designed, systematically collected, and clearly documented,
a scientific interpretation of results by experienced contamination
control personnel can allow the implementation of corrective actions
which may prevent the adverse outcomes in product manufacture or patient
care. Monitronics air and surface microbiological testing capabilities
cover all aspects of aerobacteriology. Surveys of manufacturing environments
are individually designed through the development of Protocols incorporating
applicable procedures presented within guidelines including: Current
USP <1116>, current IEST-RP-CC0023, current ISO 14698 series,
and Parenteral Drug Association Technical Reports. Monitronics instrumentation
includes many microbial air samplers to allow selection of the best
suited instrument for a given project. (slit impactors, sieve impactors,
centrifugal samplers, filter samplers). Our service does not stop
at the issuance of a report as the interpretation, statistical development
of operational limits (alert & action limits) and design of proactive
monitoring programs often prove of great service to our customers.
Our goal is to truly become an extension of our customer's internal
quality assurance program. Experience in many diverse operational
environments ensures the design of programs which meet regulatory,
operational and business objectives. |

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| Other Services:
Micro Cleaning | Air
& Surface Microbial Surveys |

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Monitronics

3450 N. Verdugo Rd.
Glendale, CA 91208
Tel: (818) 957-7960 Fax: (818) 957-7961
info@monitronicscerts.com

© 2008 Monitronics. All Rights Reserved.
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