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LABORATORY TESTING
Bioburden Extraction Efficiency Bioburden Testing Water Testing Bioburdens/Coliforms USP 61 Microbial Enumeration USP 61/.62 Method Suitability Bacteriostasis/Fungistasis Microbial Identification Sterility Testing Sterility Validation VDmax Validation Dose Audits Cleaning and Disinfection Validation Autoclave Cycle Qualification Autoclave Cycle Validation Endotoxin/Pyrogen (LAL) Validation Endotoxin/Pyrogen (LAL) Testing Cytotoxicity Testing Biological Indicator Population Verification DNase/RNase Testing Shelf Life Studies and Package Integrity Testing Environmental Chamber/Oven IQ/OQ/PQ

MicroMed offers a fully equipped laboratory and a w ide spectrum of microbiology tests. Our laboratory is in compliance w ith the ISO 13485 quality system, ISO 9001:2008 certified and complies w ith U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

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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 know n 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. Learn more about our program Bioburden Testing - ISO 11737-1, USP <1231> MicroMed tests for product bioburden to help establish sterilization validations accordance w ith ISO11737 and as part of in-process checks to help clients ensure their production processes are not compromising sterilization validations. These samples w ill be filtered after being exposed to a detergent, sonicated, incubated and colonies counted. In addition, MicroMed tests w ater samples for bioburden to ensure that w ater systems are performing w ithin the required specifications. Learn more about our program Water Testing Bioburdens/Coliform s - ISO 11737-1, USP <1231> MicroMed tests for bacterial safety of w ater samples by performing direct filtration of w ater samples. A kit containing a sterile vial can be provided to collect the w ater samples. Samples must be sent back to the lab overnight to provide accurate results. MicroMed can perform total heterotrophic testing and total coliform testing. Learn more about our program USP 61 Microbial Enum eration - 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 doesnt contain antimicrobial activity and USP 62 can be tested w ithout further modification. Learn more about our program 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 doesnt occur the device doesnt contain bacteria pertaining to certain bacteria in the enterobacteriaceae family. Learn more about our program 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 grow th media w ith a know n concentration of contaminant. This inoculation is plated as w ell to ensure the appropriate amount of bacteria/fungi w as introduced to the sample. If there is grow th similar to the positive controls, then the sample can be tested for sterility w ithout further modification. Learn more about our program Microbial Identification MicroMed can characterize and identify bacterial or fungal contaminants associated w ith 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. Learn more about our program Sterility Testing - USP <71> MicroMed performs sterility testing of devices and solutions in compliance w ith USP<71>. MicroMed

MicroMed performs sterility testing of devices and solutions in compliance w ith 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 gow ning supplies and monitor the CER routinely to ensure that it is operating w ithin specifications. Bacteriostasis/Fungistasis testing is performed in compliance w ith 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 w e know your timelines are important for lot release. We can also verify the manufacturers population claim for spore strips. Learn more about our program Sterility Validation - ISO 11137 Sterilization Validation method validates any sterilization method. The samples w ill be sent to a sterilization company to be sterilized and then sent to MicroMed. Upon reception the samples w ill be tested by sterility to assure the samples are sterile. Learn more about our program VDm ax Validation - ISO11137-2 VDmax, or ISO11137-2 method validates minimum radiation sterilization dose. A portion of the samples w ill be sterilized at an external site and shipped to MicroMed. The other non-sterile portion of sample w ill be sent straight to Micromed. Once received, the non-sterile samples w ill 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, w hich results in a reduced risk of failure. Learn more about our program Dose Audits - ISO 11137 MicroMed tests products to assess the sterility of a know n sterilization protocol. A portion of the samples w ill be sterilized at an external site and shipped to MicroMed. The other non-sterile portion of sample w ill be sent straight to Micromed. Upon reception, the devices w ill be tested for microorganism activity via bioburden and sterility. Learn more about our program Cleaning and Disinfection Validation reusable device AAMI, TIR 12, AAMI, TIR 30 Reusable medical devices must undergo cleaning and/or disinfection betw een 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. Learn more about our program Autoclave Cycle Validation - HTM 2010, EN 285, EN17765, PDA Monograph and ISO standards Our specialty is IQ/OQ/PQ, Cycle development and PQs 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 w ill be placed inside of a given device and autoclaved using the protocol to be validated. The spore strips w ill be transferred to grow th media and incubated to assist grow th. If no grow th is present the autoclave cycle is acceptable to sterilize the device. Learn more about our program 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 w ill be autoclaved using the protocol to be validated. The spore strips w ill be transferred to grow th media and incubated to assist grow th. If no grow th is present the autoclave cycle is acceptable. Learn more about our program 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 w ith the testing, routine LAL testing can be performed on the sample. Learn more about our program Endotoxin/Pyrogen (LAL) Testing - USP <85>, AAMI ST72:2002 MicroMed performs pyrogen testing in accordance w ith 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 w hen specifications are exceeded. In addition, MicroMed tests w ater samples for endotoxin contamination to ensure that w ater systems are performing w ithin the required specifications. Our testing method can detect endotoxin levels less than 0.005EU/Device. Learn more about our program 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 w ith ISO 10993-05. Learn more about our program Biological Indicator Population Verification - USP <55>, ISO 11138-1 MicroMed Laboratories can verify the manufacturers 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 know n dilution of them on a media that promotes bacterial grow th. This grow th is counted 24 and 48 hours later to confirm the spore count claim. Learn more about our program 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

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. Learn more about our program 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 (45-65C). 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 w ith shelf life studies. Learn more about our program Environm ental Cham ber/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 w ithout concerns of hot or cold spots w ithin the chamber. Learn more about our program

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