Pharmaceutical Microbiology MALDI Biotyper ® Changing Microbiology Innovation with Integrity

Fast, Accurate and Traceable Identification of Microorganisms The MALDI Biotyper System: Robust and Easy to Use Compact Bench Top System Comprehensive Species Library Easy to integrate Intuitive software 21CFR part 11 support Audit Trail User Management Data Security Electronic Signature IQ/OQ/PV documentation Ensure Safety and Quality of Pharmaceutical Products Pharmaceutical microbiologists are responsible for ensuring that the supply of life-saving drugs and vaccines are free from contamination of microorganisms. Its performance reaches far beyond traditional methods and its outcome is comparable...

Straightforward to Result There is nothing faster - and easier The MALDI Biotyper identifies microorganisms using MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) Mass Spectrometry to determine the unique molecular fingerprint of an organism. The characteristic spectrum pattern of this molecular fingerprint is used to reliably and accurately identify a particular microorganism by matching thousands of reference spectra of microorganism strains. The MALDI Biotyper workflow has been designed to be as robust and easy to perform as possible. Only a few simple steps are required...

Rigorous and Sophisticated Data Analysis Assures Accuracy Meaning of score values The acquired spectrum of the sample is transformed into a peak pattern, utilizing dedicated spectral analysis tools. This pattern is compared to reference peak lists of organisms in the reference database and a log(score) value between 0.00 and 3.00 is calculated. organism in the reference database. Values ≥ 2 (green) indicate high confidence identifications. Log (score) values between 1.70 and 1.99 (yellow) need to be confirmed by additional methods. Values below 1.70 (red) indicate that no organism identification...

Intuitive Software Tailored to the In just a few easy steps, the simple-to-use software guides users through the set-up of an isolate or batch of isolates for analysis. Convenient user interface for easy set-up of working lists a performance check using a QC standard. This guarantees consistent system performance for every spectra acquisition Clear identification results display at species level played in a standardized report after acquisition of spectral data The report lists the best match for each sample along with the associated log(score) value

The Best Technology from the Experts in Mass Spectrometry As leader in MALDI-TOF technology it is of great importance to us to design robust, compact, high performance platforms intended for extensive and routine usage in the microbiology laboratory. The core of the MALDI Biotyper system is the cutting-edge microflex LT/SH MALDI-TOF mass spectrometer. A space saving system A true bench-top solution taking up less than 1 meter/ 40” of counter space to provide flexibility in meeting laboratory needs. Requires only a 110/220 V electrical supply and generates minimal thermal output. Resolution meets...

Continuous Process Control Installation qualification (IQ) and operation qualification (OQ) for new technologies in the Quality Control laboratory must be efficiently performed and documented. Dedicated documents for the MALDI Biotyper IQ and OQ-PV are provided which fully supports 21 CFR part 11 compliance. Design Qualification Installation Qualification User requirement specifications (URS) Functional Requirement Specification (FRS) System installation check Specification Check after installation Perfomance Qualification Operational Qualification System-Perfomance-Test to start validation to...

MALDI Biotyper System Overview Microbial Identification Applications Gram +/- Bacteria, Yeast, Filamentous Fungi, Mycobacteria System Components Instrument: microflex LT/SH Mass Spectrometer (manufactured under QSR regulations) MALDI Biotyper datasystem running under Windows 7 MALDI Biotyper System Software HCCA Matrix Bacterial Test Standard (BTS) Reusable polished stainless steel targets: 48 & 96 position with barcode Disposable 48 position biotarget with individual barcode System Implementation and Qualification IQ and OQ-PV documentation 21CFR part 11 support (option) Accessories MALDI Biotyper...