Portable detection systemsfor bacterial contamination

Microbiological testing of pharmaceutical and medicaldevice products is critical to ensuring patient safety. Whilethis is particularly the case for sterile products such asparenterals, implants, stents and contact lenses, oral dosepharmaceuticals must also meet strict regulatory microbialstandards. Detecting microbial contamination remains achallenge. The initial microbial cell load of the sample istypically low, thereby necessitating the culturing of themicroorganisms to enable detection and enumeration bycurrent methodologies. This process is inherently slow,taking several days and delaying the release of products tothe market or resulting in equipment down-time. Anyanalytical solution to this problem must be able to detectmicrobiological contamination at the levels present during,or shortly after, sampling. To be suitable for a typicalquality control laboratory, any test method should havesimple sample preparation procedures and should notrequire complex and expensive equipment.

MICROPRINT meets these challenges and offers thepotential for development of rapid and highly sensitive celldetection assays using cell imprinted electrochemicalsensors.

Rapid Bacterial Detection

Cell Imprinted Electrochemical Sensors

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Integrated microfluidics Cell imprinted polymer for selective capture Electronic sensors - cellular enzyme profiles

MICROPRINT is an analytical microbiology technologybased on cell-enzyme profiling sensors. The technologyconsists of a single-use cell capture and detectioncartridge; BIO-CARD and a portable electronic readerwhich processes cartridges and collects data on specificmicroorganisms. BIO-CARD device encompasses novelcell-capture membranes integrated with electrode sensorswhich quantifies electrons derived from assigned cellularenzyme reactions.

No user training required No sample preparation Cost effective (reader €500 and <€1 per analysis) Self-contained (no external reagents required) Results available within same shift (<8 hrs) Sterile and non-obligatory sterile products Facilitate rapid go/no-go decisions within

manufacturing environment Sensitive; 1 cfu/mL Multiple, specific organism tests into single card

MICROPRINT

MiCRA - BiodiagnosticsInstitute of Technology Tallaght

Old Blessington Road, Tallaght, Dublin 24

www.micra.ie

Sterile Manufacturing

Manufacturing in cleanroom environments is standardpractice in Biotechnology and Pharma qualitymanagement. To avoid lengthy production down-time,sources of microbial contamination must be quickly locatedand remedial action undertaken. Contamination mayoriginate from the raw materials or may be introducedduring manufacture. Water, raw materials & ingredients,products of sterile filtration and environmental swabsamples are assessed to identify and enumerate indicatormicroorganisms. Rapid bacterial analysis must beestablished to detect at the alert level of 1cfu/100mL.

Opportunities

MICROPRINT allows on-the-spot microbiological analysis,whether at the laboratory bench or at the production line.A portable bench form of the system is being scrutinisedfor the evaluation of total viable aerobic count (TVAC) inpharmaceutical preparations. It is envisaged that thetechnology will be extended to other industrial needsincluding food and water testing. The technology is alsobeing assessed for continuous on-line/in-line monitoringQA applications.

Industrial technologies for rapidmicrobiological testing currently costup to $100 per sample, require highcapital equipment costs and still leadto identification error rates of 20% orgreater.

Microbiological Technologies fromMiCRA

MICROPRINT BIO-CARD &HANDHELD READER is underdevelopment at MiCRA for thedetection of bacteria in waterand food samples. In watertesting, a water sample isinjected through a samplingstrip which is then inserted intothe BIO-CARD. After a periodfor on-cartridge culturing, thecard is introduced to thehandheld reader forprocessing. Readout follows inminutes identifying the micro-organism and cell count.

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Staphylococcus Micrococcus Salmonella Escherichia coli Aspergillus niger Candida albican

MiCRA - Biodiagnostics is advancing new electrochemicalsensors and electrode devices to meet a diverse range ofindustry applications. In addition to the range of cellimprinted electrochemical sensors, under development area suite of microbiological assays, on-the-spot celldiagnostics and in-line electronic sensors for identificationand enumeration of bacteria.

MOXYS - Microbial Oxygen Sensor‘MOXYS’ is a thin-layer electrochemical oxygen sensor,built using printed polymer laminates, and designed tomonitor real-time microbial oxygen metabolism. Thesensor is used to enumerate catalase positive bacteria.

Coliform SensorsElectronic sensors detect E. coli and coliforms bymeasuring beta-galactosidase and related enzymeactivities. The detection system is being used for watertesting for the presence of E. coli, providing rapid cell countresults.

CATOXE – Staphylococci & Micrococci Dual SensorsBIO-CARD cartridges are under development usingintegrated dual sensors for the identification anddifferentiation of staphylococci from micrococci in sterilemanufacturing samples.

TVAC UNIVERSAL‘TVAC UNIVERSAL’ is a technology to detect respiringmicroorganisms using CO2 gas monitoring sensors. Theelectrode-based instrument evaluates total viablecounts and has a range of industrial applications wheremicroorganism contamination is an issue.