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Environmental Monitoring
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| FDA requires routine monitoring of clean rooms and other controlled
environments for microbial and particulate content according to
ISO 14698-1. Many organisms can put a product at risk for adulteration
and can put the consumer or patient at risk for infection. Gibraltar's program includes enumeration and identification
of bacteria and fungi. Organisms isolated can be screened for antibiotic
resistance.
Gibraltar sends trained specialists to your facility to obtain air, water
and surface contaminants. The
following questions are important in managing a contamination
control program:
What organisms are present?, How did they get there?, How do you get
rid of them?, What is their impact on product and/or the consumer?
GBL offers Special Services As Needed By Our Trained, Experienced and Knowledgeable
Staff |
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Environmental Audit
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Site visit and consultation
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Development
of SOPs, Establishment of Action/Alert Limits |
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Staff Training |
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General
consulting (FDA Guidelines) on contamination |
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control, plant hygiene, sanitization, disinfection, pathogenicity and spoilage
potential of organisms,sterility testing (USP). |
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Routine Testing Services (as per client schedule and specs) |
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Sampling done by GBL or by client |
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Monitoring using contact plates, settling plates and swabs. |
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Air monitoring (viable and particulate,non-viable) |
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Personnel monitoring, sterility garb testing (gowning validation) |
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Compressed gas monitoring (viable,particulates, purity) |
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Speciation or biocharacterization of specific or all organisms,
as requested, according to the following: |
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Tier 1: Colonial morphology of isolates obtained during predisinfection
phase (baseline) of surfaces, air and/or personnel. |
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Tier
2: Biocharacterization to category(i.e. gram positive, gram negative, yeast, mold, etc.). |
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Tier
3: Automated microbial identification of computer-generated probabilities
of identity - genus and species. |
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Same Day Testing and Rapid Reporting. |
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Value added – Additional Services (Support Services) |
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Value Added at times offered at no additional charge. |
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Trending Analysis and Control Charts. |
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For aseptic fill operations: aseptic fill validations, viral disinfection services or viral monitoring, as may be
required. Microbial content of non-sterile products. |
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