Laboratory
Testing
Bioburden
Extraction Efficiency - ISO 11737-1, USP <1231>
MicroMed tests devices to establish bacterial contamination of a given device. This is done by inoculating a known amount of thermostable bacteria on a given device in triplicate. The bacteria are then extracted, filtered, plated and incubated. Once this is performed the amount of inoculum is counted against the dilution set up to calculate the extraction efficiency factor (EEF) of the given device. This EEF is then used to calculate the actual amount of bacteria present on future bioburdens.
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Bioburden
Testing - ISO 11737-1, USP <1231>
MicroMed tests for product bioburden to help establish sterilization validations accordance with ISO11737 and as part of in-process checks to help clients ensure their production processes are not compromising sterilization validations. These samples will be filtered after being exposed to a detergent, sonicated, incubated and colonies counted. In addition, MicroMed tests water samples for bioburden to ensure that water systems are performing within the required specifications.
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Water Testing – Bioburdens/Coliforms - ISO 11737-1, USP <1231>
MicroMed tests for bacterial safety of water samples by performing direct filtration of water samples. A kit containing a sterile vial can be provided to collect the water samples. Samples must be sent back to the lab overnight to provide accurate results. MicroMed can perform total heterotrophic testing and total coliform testing.
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USP 61 Microbial Enumeration - USP <61>
MicroMed tests devices for antimicrobial activity and sterile specifications using a neutralization format. The devices are exposed to an array of quantified microorganism indicators and a neutralization agent. The exposure of microorganisms and neutralization agent is filtered, plated and incubated to allow for enumeration. If enumeration does occur the device doesn’t contain antimicrobial activity and USP 62 can be tested without further modification.
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USP 61/.62 Method Suitability - USP <61>, USP <62>
MicroMed tests devices for enterobacteriaceae activity and sterile specifications using a neutralization format. The devices are exposed to an array of quantified microorganism indicators and a neutralization agent if needed per USP 61. The exposure of microorganisms and neutralization agent, if needed, is filtered, plated and incubated to allow for enumeration. If enumeration doesn’t occur the device doesn’t contain bacteria pertaining to certain bacteria in the enterobacteriaceae family.
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Bacteriostasis/Fungistasis - USP <71>
Bacteriostais/Fungiostasis is used to test samples to determine if there are antimicrobial properties of a given sample so they can be used for further sterility testing. MicroMed tests sterile samples by introducing them to bacteria/fungi infested growth media with a known concentration of contaminant. This inoculation is plated as well to ensure the appropriate amount of bacteria/fungi was introduced to the sample. If there is growth similar to the positive controls, then the sample can be tested for sterility without further modification.
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Microbial Identification
MicroMed can characterize and identify bacterial or fungal contaminants associated with Environmental Monitoring, Sterility, and Bioburden Testing. Using an array of biochemical assays to identify unique characteristics, bacteria or fungus can be identified to genus and species.
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Sterility
Testing - USP <71>
MicroMed performs sterility testing of devices
and solutions in compliance with USP<71>.
MicroMed performs all tests in a state of the
art Class 100 Clean Room in the confines of a
biological safety cabinet to reduce the risk of
false positives. Our technicians use only sterile
gowning supplies and monitor the CER routinely
to ensure that it is operating within specifications.
Bacteriostasis/Fungistasis testing
is performed in compliance with USP <71>
to validate that samples do not possess antimicrobial
activity that may cause false negatives in sterility
samples.
All EtO sterilization related
spore strips are processed as soon as possible
priority items upon receipt because we know your
timelines are important for lot release. We can
also verify the manufacturer’s population
claim for spore strips.
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Sterility
Validation - ISO 11137
Sterilization Validation method validates any sterilization method. The samples will be sent to a sterilization company to be sterilized and then sent to MicroMed. Upon reception the samples will be tested by sterility to assure the samples are sterile.
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VDmax
Validation - ISO11137-2
VDmax, or ISO11137-2 method validates minimum radiation sterilization dose. A portion of the samples will be sterilized at an external site and shipped to MicroMed. The other non-sterile portion of sample will be sent straight to Micromed. Once received, the non-sterile samples will be tested for microorganism activity utilizing EEF and bioburden, and the sterililized samples tested for bacteriostasis/fungistasis and sterility. VDmax requires a low number of test samples thus reducing costs. VDmax calculates the highest verification dose possible for your product, which results in a reduced risk of failure.
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Dose Audits - ISO
11137
MicroMed tests products to assess the sterility of a known sterilization protocol. A portion of the samples will be sterilized at an external site and shipped to MicroMed. The other non-sterile portion of sample will be sent straight to Micromed. Upon reception, the devices will be tested for microorganism activity via bioburden and sterility.
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Cleaning and Disinfection Validation – reusable device – AAMI,
TIR 12, AAMI, TIR 30
Reusable medical devices must undergo cleaning and/or disinfection between patients. MicroMed can perform validation studies to ensure that cleaning/disinfection methods are adequate. Such studies involve inoculation of the device and are used to simulate manufacturer recommended cleaning instructions. In addition to the microbiological testing, validation includes cytotoxicity testing to ensure that residuals from the cleaning and disinfection process have been removed.
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Autoclave Cycle Validation - HTM
2010, EN 285, EN17765, PDA Monograph and ISO
standards
Our specialty is IQ/OQ/PQ, Cycle development and PQ’s of Autoclaves. Performance qualification (validation) is an accurate method of assessing and maximizing the efficiency of your autoclave cycles and your individual load types. Spore strips will be placed inside of a given device and autoclaved using the protocol to be validated. The spore strips will be transferred to growth media and incubated to assist growth. If no growth is present the autoclave cycle is acceptable to sterilize the device.
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Autoclave Cycle
Qualifications - ANSI/AAMI/ISO
11134-1993
MicroMed can qualify a standard cycle for use on your product per ANSI/AAMI/ISO 11134-993 this cycle can then be duplicated at the final use site. Spore strips will be autoclaved using the protocol to be validated. The spore strips will be transferred to growth media and incubated to assist growth. If no growth is present the autoclave cycle is acceptable.
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Endotoxin/Pyrogen
(LAL) Validation - USP
<85>, AAMI ST72:2002
Validations are performed on samples prior to beginning routine LAL testing. 3 lots of a given sample type are tested individually to verify extraction methods and ensure the sample has no inhibition or enhancement of the assay. Once the extraction method has been forged and the sample has been found not to interfere with the testing, routine LAL testing can be performed on the sample.
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Endotoxin/Pyrogen
(LAL) Testing - USP
<85>, AAMI ST72:2002
MicroMed performs pyrogen testing in accordance with AAMI and USP<85> guidelines to determine the level of bacterial endotoxin present on devices. MicroMed provides kinetic turbidimetric, chromogenic and gel clot methods. Our experts can help determine sources of endotoxin when specifications are exceeded. In addition, MicroMed tests water samples for endotoxin contamination to ensure that water systems are performing within the required specifications. Our testing method can detect endotoxin levels less than 0.005EU/Device.
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Cytotoxicity
Testing - USP <87>, ISO 10993-5
Cytotoxicity testing is used to determine if products contain any toxic leechable properties. MicroMed offers quantitative and qualitative assays using L-929 fibroblast cells from mice. Clients use this service to release raw materials and during non-conformance investigations to ensure products are not contaminated. Cytotoxicity testing is performed in compliance with ISO 10993-05.
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Biological
Indicator Population Verification - USP
<55>, ISO 11138-1
MicroMed Laboratories can verify the manufacturer’s population claim for spore strips in support of EtO Sterilization Validations. This is performed by creating a ubiquitous solution of spores from the manufacturer spore strips and plating a known dilution of them on a media that promotes bacterial growth. This growth is counted 24 and 48 hours later to confirm the spore count claim.
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DNase/RNase
Testing
DNase and RNase are ubiquitous
in the environment, and in some biological materials.
They are present in relatively high concentrations.
RNase frequently contaminates common molecular
biological reagents such as reaction buffers,
enzymes such as reverse transcriptase, RNA polymerase,
and buffers for RNA purification and storage.
DNase degrades DNA and its presence is a threat
to many molecular biology experiments. MicroMed
can test for DNase and RNase contaminants.
Certify plastics, enzymes, solutions and other
biomaterials as "DNase/RNase-free" prior
to DNase/RNase-sensitive applications such as
PCR.
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Shelf
Life Studies and Package Integrity Testing - ISO 11607, ASTM F1929, ASTM 1140
MicroMed maintains accelerated aging ovens set
at the common temperatures used for medical device
studies (45-65ºC). In addition to the aging of
the samples, MicroMed can perform a variety of
tests to help support shelf life and packaging
validation studies that are usually associated
with shelf life studies.
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Environmental Chamber/Oven IQ/OQ/PQ
Our specialty is developing IQ/OQ/PQ protocols for Environmental Chambers in need of temperature/performance mapping. The Performance Qualification ensures shelf life studies are performed in chambers that maintain temperatures over the life of the study without concerns of hot or cold spots within the chamber.
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