(usp-iso)-micromed laboratories- microbiology testing, cer monitoring, and consulting

7/30/2019 (USP-IsO)-MicroMed Laboratories- Microbiology Testing, CER Monitoring, And Consulting

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LABORATORY TESTING

Bioburden Extraction

Efficiency

Bioburden Testing

Water Testing

Bio burdens/Coliforms

USP 61 Microbial

Enumeration

USP 61/.62 Method

Suitability

Bacteriostasis/Fungistasis

Microbial Identification

Sterility Testing

Sterility Validation

VDmax Validation

Dose Audi ts

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 I ntegrity 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 certif ied and complies w ith U.S. GMP

and Quality System Regulations. Our experts understand your needs for quality testing and timely,

accurate results.

Laboratory Testing

Bioburden Extraction Efficiency - ISO 11737-1, USP

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 upto calculate the extraction efficiency f actor (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

MicroMed tests f or product bioburden to help establish s terilization 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 af ter being exposed to a detergent,

sonicated, incubated and colonies counted. In addition, MicroMed tests w ater samples for bioburden to

ensure that w ater sys tems are perf orming w ithin the required specifications.


Water Testing Bioburdens/Coliforms - ISO 11737-1, USP

MicroMed tests for bacterial safety of w ater samples by perf orming 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 prov ide accurate results. MicroMed can perform total heterotrophic testing and total

coliform testing.


USP 61 Microbial Enumeration - USP

MicroMed tests devices f or antimicrobial activity and s terile 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 f or

enumeration. If enumeration does occur the device doesnt contain antimicrobial activity and USP 62 can

be tested w ithout further modification.


USP 61/.62 Method Suitability - USP , USP

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.


Bacteriostasis/Fungistasis - USP

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 s terile samples by

introducing them to bacteria/fungi infested grow th media w ith a known 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 s terility

w ithout further modification.


Microbial Iden tification

MicroMed can charac terize and identify bacter ial 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.


Sterility Testing - USP

Download Sample

Submission Form (PDF)

Download Sample

Submission Form (Word

Doc)

How To Submit Your

Sample Submission Form

(PDF)

ISO Certificate

(PDF)
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c ro e per orms s ter ty tes tng o evces an soutons n comp ance w t < >. c ro e

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 s terile gow ning supplies and

monitor the CER routinely to ensure that it is operating within spec ificat ions.

Bacter iostasis /Fungistasis tes ting is perfor med in compliance w ith USP to validate that samples do

not possess antimicrobial activity that may cause f alse 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 s trips.


Sterility V alidation - ISO 11137

Sterilization Validation method validates any ster ilization method. The samples w ill be sent to a

ster ilization company to be sterilized and then sent to MicroMed. Upon reception the samples w ill be

tested by s terility to assure the samples are sterile.


VDmax 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-ster ile portion of sample w ill

be sent s traight 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. V Dmax calculates the

highest verif ication dose possible for your product, w hich results in a reduced risk of f ailure.


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 ster ilized at an external site and shipped to MicroMed. The other non-ster ile portion of

sample w ill be sent straight to Micromed. Upon reception, the devices w ill be tested for microorganism

activity v ia bioburden and s terility.


Cleaning and Disinfection V alidation 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.


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 y our autoclave cyc les

and your individual load types. Spore str ips w ill be placed inside of a given device and autoclaved using

the protocol to be validated. The spore strips w ill be transf erred 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.


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

cyc le 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.


Endotoxin/Pyrogen (LAL) Validation - USP , 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 perf ormed on the sample.


Endotoxin/Pyrogen (LAL) Tes ting - USP , AAMI ST72:2002MicroMed perf orms pyrogen tes ting in accordanc e w ith AAMI and USP 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 f or endotoxin contamination to ensure that w ater

sys tems are performing w ithin the required specifications. Our testing method can detect endotoxin

levels less than 0.005EU/Device.


Cytotoxicity Tes ting - USP , ISO 10993-5

Cytotoxicity testing is used to determine if products contain any toxic leechable properties. MicroMed

off ers quantitative and qualitative assays using L-929 fibroblast cells from mice. Clients use this serv ice

to release raw materials and during non-conformance investigations to ensure products are not

contaminated. Cytotoxicity testing is perf ormed in compliance with ISO 10993-05.


Biological Indicator Population Verification - USP , ISO 11138-1

MicroMed Laboratories can verify the manufacturers population claim for spore str ips in support of EtOSterilization Validations. This is perf ormed 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

grow th. This grow th is counted 24 and 48 hours later to conf irm the spore count claim.


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
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such as reaction buffers, enzymes such as reverse transcriptase, RNA polymerase, and buffers for

RNA purif ication 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.


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 perf orm a variety of tests to

help support shelf life and packaging validation studies that are usually associated w ith shelf life

studies.


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 s tudy w ithout concerns of hot or

cold spots w ithin the chamber.


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