Introducing BioLaz - CPAC

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Materials tests• Nitrile Gloves• Cleanroom Gowns• Wipes, cloths• The presence of whiteners or cellulose cancause some level of fluorescence breakthrough,but these were only seen whilst directly injectingmaterial into the Biolaz inlet and tests in normalcleanroom usage suggest this is not a significantsource of counts.
Our Approach• Step 1: – Can we validate instrument performance toUSP and EP?• Step 2: Validate that common chemicals and materialsin the aseptic environment do not interfere• Step 3: Integrate <strong>BioLaz</strong> into our currentenvironmental monitoring system• Step 4: Establish operational levels in asepticenvironments• Step 5: Dialogue with regulatory bodies to establishcriteria for operational use
Page 1 and 2: BioLaz Real Time MicrobialMonitorin
Page 3 and 4: Who We Are:• Particle Measuring S
Page 6 and 7: Microbiological MonitoringToday….
Page 8 and 9: Typical active air sampling -portab
Page 10 and 11: Real Time Microbial Monitoring
Page 13 and 14: Limitations of Impactiontechnologie
Page 15 and 16: Rapid Microbial Methods
Page 17 and 18: Cell Structure• All living cells
Page 19 and 20: Optical Fundamentals• The sample
Page 21 and 22: Data Output - 4 channels• Small P
Page 23 and 24: USP / EP Validation
Page 25 and 26: USP and EP 5.1.6Not requiredRequir
Page 27 and 28: Validation Test Setup
Page 29 and 30: Initial Microorganisms Tested:• 4
Page 31 and 32: Test Results Summary (concentration
Page 33 and 34: Example of Individual Bs TestCultur
Page 35 and 36: Bs Linearity
Page 37 and 38: Initial EP /USP ValidationConclusio
Page 39 and 40: Can common disinfectants /cleaning
Page 41 and 42: Shield Medicare BiocidesDate Descri
Page 43: Biocide testing:• Nebulized Bioci
Page 47 and 48: System Integration• Biolaz is not
Page 49 and 50: Installation QualificationProbe & T
Page 51 and 52: Performance Qualification• Verify
Page 53 and 54: Incorporation into EnvironmentalMon
Page 55 and 56: Monitoring Applications• Filling
Page 57 and 58: BioLaz Benefits• Faster batch rel
Page 59 and 60: Our Approach• Step 1: - Can we va
Page 61 and 62: 0:00:070:34:271:08:481:43:112:17:31
Page 63 and 64: 00.511.522.50:00:020:32:561:05:461:
Page 65 and 66: 0:00:010:31:211:02:421:34:022:05:23
Page 67 and 68: BIOLAZGRADE B IN OPERATION00.511.52
Page 69 and 70: BIOLAZ evaluationSummary data09 dec
Page 71 and 72: Calibration
Page 73 and 74: Sensor CalibrationThe software auto
Page 75 and 76: BioLaz Summary• Real-time, contin
Page 77: Questions?

Introducing BioLaz - CPAC

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