Microbial Environmental Monitoring
It is critical for Medical Device and Biologicals manufacturers to maintain sterile environments to ensure the safety of their products. Routine monitoring of manufacturing facilities is essential to assess the bioburden level in manufacturing facilities. Clongen Laboratories, LLC is prepared to help you accomplish your environmental monitoring goals.
Samples from the air and surfaces are collected during daily production operations and analyzed to obtain actual data on the manufacturing environment. Quality assurance personnel document details of work practices at the time the sample collection takes place and those observations are shared with upper management to make the proper recommendations if necessary. Environmental monitoring samples can be collected by a Clongen Laboratories, LLC staff member if the location is within 25 miles from Germantown, MD or onsite at the client's location by client's personnel. We offer our clients the option to choose the protocol, growth media and strategy for sample collection. We are prepared to provide media, collection protocols and training to your staff if you prefer. Once samples are collected, they should be shipped overnight to our laboratories in a condition that avoids exposure to extreme temperatures. It usually takes our staff 5-7 business days to turn out a report on counts as well as genus and species identification of the isolates.
Clongen Laboratories, LLC offers the most cost-effective programs and technical support to ensure that sampling is performed as it should and to minimize delays and provide you with results in the shortest time possible.
Environmental Survey – Microbiological
Test Description |
Protocol |
Turnaround Time |
Rodac Plate (colony counts, Gram staining) |
ET101 | 2-5 days |
Water Analysis (colony counts, Gram staining) |
ET102 | 2-5 days |
Water Analysis (colony counts, Gram staining and microbial identification) |
ET103 | 4-7 days |
Environmental Swabs (Gram staining) |
ET104 | 1-3 days |
Diagnostic Work on Suspect Organisms (fees are per isolate) |
ET105 | 4-7 days |
Microbial Environmental Monitoring Supplies *
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Fallout Plate, 100 mm, Tryptic Soy Agar (TSA)
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Fallout Plate, 100 mm, Sabouraud Dextrose Agar (SDA)
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Contact Plate, Tryptic Soy Agar
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Contact Plate, Sabouraud Dextrose Agar
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Sterile Buffer Solution w/Dacron Swab
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Sterile Specimen Cups, Screw Cap, 120 mL
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Surgeon’s Gloves, Latex, Sterile (available in sizes 6 to 8 ½)