1 / 54

TOC and Conductivity for USP and EP Water Systems

TOC and Conductivity for USP and EP Water Systems. Content. Conductivity TOC analysis Validating a TOC analyzer Introduction to the PAT700 combined TOC and Conductivity Analyzer. Dissociation and Conductivity. Conductivity measures ionic activity

blue
Download Presentation

TOC and Conductivity for USP and EP Water Systems

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. TOC and Conductivity for USP and EP Water Systems

  2. Content • Conductivity • TOC analysis • Validating a TOC analyzer • Introduction to the PAT700 combined TOC and Conductivity Analyzer

  3. Dissociation and Conductivity • Conductivity measures ionic activity • Ionic compounds dissociate into ions, then re-associate back into the compound • E.g. Sodium Chloride (NaCl) made from Na+ and Cl- • Add energy and the Na+ and Cl- split, or dissociate • The ions then contribute to the conductivity of the water • Some substances dissociate more readily and contribute more strongly to conductivity • Different temperature compensation curves for different waters

  4. + - + - Conductivity Conductivity Meter Na+ Cl- Measurement Cell

  5. Conductivity varies with temperature Conductivity = TOC Temperature

  6. USP<645> Conductivity & Temperature • Conductivity meters will report different results depending on: • The compounds present in the water • The temperature compensation curve selected • Hence pharmacopoeias call for un-compensated, e.g. USP<645>:

  7. Content • Conductivity • TOC analysis • Validating a TOC analyzer • Introduction to the PAT700 combined TOC and Conductivity Analyzer

  8. + - + - On-line TOC analysis – principle of operation Conductivity Meter Measurement Cell UV lamp

  9. Organic material turned to CO2 - + - + + - + + + - - - On-line TOC analysis – principle of operation Conductivity Meter UV UV

  10. Organics oxidised to CO2 d conductivity = TOC On-line TOC analysis - Principle of Operation Conductivity UV on Time

  11. Letter of the Law USP (‘till recently) “… share the objective of completely oxidizing the organic molecules in an aliquot of sample water to carbon dioxide…” EP states “… have in common the objective of completely oxidizing the organic molecules in the sample water to produce carbon dioxide…” Only Hach’s, End Point Detection method, strictly meets this requirement for online TOC analyzers

  12. Dynamic End Point Detection USP <643> Requirement: Instrument Must Completely Oxidize the Sample

  13. Content • Conductivity • TOC analysis • Validating a TOC analyzer • Introduction to the PAT700 combined TOC and Conductivity Analyzer

  14. Validating the TOC analyser • Validate that the instrument matches the URS • Validate that installation is as per manufacturer • Verify Calibration • TOC • Conductivity • Temperature sensor • System suitability • Verify connections to remote systems • Performance qualification • Calibration is stable • Analyser works correctly

  15. Tests to validate the analyser • Validate that the instrument matches the URS • Validate that installation is as per manufacturer • Verify Calibration • TOC • Conductivity • Temperature sensor • System suitability • Verify connections to remote systems • Performance qualification • Calibration is stable • Analyser works correctly

  16. Week 1 IQ, Commissioning First 4 weeks Calibration stability, System suitability Validation documents & procedures • Demonstrate URS requirements are met through, Commissioning, IQ and OQ • PQ demonstrates that the analyzer is stable and can support required calibration and system suitability intervals 6 monthly testing

  17. Tests to validate the analyser • Verify that the instrument matches the URS • Verify that installation is as per manufacturer • Verify Calibration • TOC • Conductivity • Temperature sensor • System suitability • Verify connections to remote systems • Performance qualification • Calibration is stable • Analyser works correctly

  18. TOC Calibration – factory & on site Factory Calibration 0 Reported TOC 1000 0 Injected TOC 1000

  19. 750ppb 500ppb 250ppb Water system TOC value – modern system = 30 to 70ppb TOC Calibration on site TOC

  20. Certified traceable standards

  21. Calibration – As Found, As Left

  22. System Suitability Test Must Be Performed System Suitability is not calibration! System suitability is “the process of validating whether your system (i.e. TOC analyzer) is acceptable for providing useful analytical data without any bias.” This is typically done by: • Analyzing a material that is easy-to-oxidize (sucrose) • Analyzing a material that is difficult-to-oxidize (1,4 - benzoquinone) • Calculating the ratio of the responses

  23. System suitability – USP<643> & EP2.2.44

  24. Calculation = Sucrose = 475 = >85%<115% Benzoquinone 485 System suitability calculation Sucrose analysis result = 475ppb TOC Benzoquinone analysis result = 485ppb TOC

  25. Verifying conductivity – USP<645> • Verify meter accuracy (+/- 0.1mS) • Verify cell constant (+/-2%) • Verify temperature sensor (compensation)

  26. Temperature sensor verification

  27. Accuracy of meter Verifying conductivity – meter accuracy

  28. Disconnect measurement cell Verifying conductivity – meter accuracy

  29. Meter = Resistor +/-0.1mS Replace cell with NIST traceable resistor Verifying conductivity – meter accuracy

  30. Area Distance Verifying conductivity – cell constant Function area and distance

  31. Verifying conductivity – cell constant • Introduce certified conductivity standard • +/-2% of certified standard • Cell constant known within +/-2%

  32. Content • Conductivity • TOC analysis • Validating a TOC analyzer • Introduction to the PAT700 combined TOC and Conductivity Analyzer

  33. PAT700 TOC Analyzer with OASISTM Onboard, Automated Standards Introduction System

  34. Introduction to the ANATEL PAT700 • On-line TOC analysis with complete sample oxidation • OASISTMOnboard, Automated Standards Introduction System • Calibration and system-suitability test SOP built-in via color touch-screen • Individual 4-20mA outputs for TOC, temperature and conductivity • Main and standby auto-switching UV lamps with UV Detect™ technology • IP 56 stainless-steel enclosure improves protection from water and particulates

  35. PAT700 – Supports all test requirements • USP <643> Total Organic Carbon • USP <645> Conductivity • USP <788> Water for Injection • USP <789> Opthalmic Water • EP 2.2.38 Conductivity • EP 2.2.44 Total Organic Carbon • JP <60> • 21 CFR Part 11

  36. OASISTM Technology Saves time and delivers improved confidence in quality • All bottles for a test installed at once and tests automated • Information about each standard stored in RFID tag on the bottle • contents, concentration, certified value, lot number, expiration date • (Manual data entry possible for customer prepared standards) • Analyzer voids bottle following test • OASIS can be used for grab sample analysis

  37. Non-Hach Standards Warning Message If the user selects “No”, then the test is cancelled and the user is placed back at the Run Standards selection screen.  If the user selects “Yes”, then the user is prompted to enter all of the bottle information manually and the test is allowed to continue as if the bottle did not have an RFID tag at all.

  38. PAT700 TOC Analyzer with OASISTM Grab-sample analysis

  39. Grab Sample Analysis • Utilizes OASIS sample bay • Up to 4 grab sample bottles at a time • Grab Sample Bottle ID nine character alphanumeric • (ex. PW POU 01 )

  40. PAT700 TOC Analyzer with OASISTM OOS sample capture and root-cause analysis support

  41. OOS sample capture capability Utilizes OASIS sample bay OOS triggers automatic collection of two samples Re-tests 1 bottle to confirm OOS Saves one sample for analysis in laboratory to support root-cause analysis

  42. PAT700 TOC Analyzer with OASISTM 21 CFR data export

  43. 21 CFR Part11 Data Export TOC Dataview PC Software Allows the viewing of encrypted data Allows decrypted data to be saved Encrypted file exported as filename.hef Read-only .pdf for record retention .txt files to load into LIMS database

  44. PAT700 TOC Analyzer with OASISTM Clean-In-Place verification

  45. On-line Monitoring of CIPFinal Rinse Water Verification Conductivity can be used for detecting acid wash residues TOC can be used as broad-spectrum test to detect presence of drug material residues Unit programmed to meet user’s specific criteria • Either conductivity threshold • Or time based After TOC analysis, reports results and return to idle mode

  46. On-line Monitoring of CIPFinal Rinse Water Verification • Automated Mode (plc controlled): • Unit idle until called for • TOC analysis triggered via: • Digital input, or • Serial command, or • Modbus over Ethernet • Reports results and return to idle mode

  47. PAT700 TOC Analyzer with OASISTM Laboratory TOC analysis

  48. PAT700 with auto-sampler • Autosampler for laboratory use can load up to 36 vials • e.g. point-of-use and rinse water samples.(0-2000ppb) • Provides a laboratory TOC analyzer without reagents or carrier gas

  49. PAT700 TOC Analyzer with OASISTM Water loop monitoring and root-cause analysis support

  50. Dual-stream option PAT700 Two inputs • One on the PW/WFI loop start, one on the return • Brackets loop quality • Helps root-cause investigation to find contamination source, e.g. feed-water or point-of-use

More Related