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LSUG 2011 Revised CR 2

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LSUG 2011 Revised CR 2 Monitoring Compressed Air/Gas for Particles 1 FDA: Air (CDA) or Gas that contacts Product 2 Air (CDA) or Gas that contacts Product Frequency of sampling and target levels for CDA/Gases It would seem that the authorities have not established a periodicity for sampling of compressed gas sources. In cases where there is concern that there might be some risk, it may be wise to sample gas sources on a quarterly basis and to set an expectation of an ISO 7 level in non- sterile applications; for sterile areas, a target of ISO 5 or better should be used. Many customers look for an ISO 4 level in sterile gas supplies and this should be achievable with most commercially available filter methods. This higher target level is, however, one of choice, rather than one dictated by regulation (but does add some safety margin). Also, for sterile areas, a more frequent - monthly or even weekly - sampling may help minimize any lengthy period of heightened risk due to a system failure. 3 MET ONE 3400 for CDA/Gas testing Ordering a Particle Counter for Gas Sampling The new 3400 gas option, together with the appropriate High Pressure Diffuser (HPD), makes gas monitoring straight-forward. The user simply selects the required gas from a pull-down list on the 3400 interface; the sample flow is automatically adjusted to ensure that a calibrated flow rate is maintained to specification. Ordering a new 1 CFM 3400 with gas calibration is likewise straight-forward. Four versions are available, and include gas calibrations for these gases: Air, N2, and CO2. 2088900-06 3413 0.3 micron, 1 CFM, GASES 2088900-07 3413 0.3 micron, 1 CFM, GASES, WIFI 2088900-08 3415 0.5 micron, 1 CFM, GASES 2088900-09 3415 0.5 micron, 1 CFM, GASES, WIFI For the 1 CFM counters listed above, select the 2080732-13 HPD. Note that HPD versions are available for other flow rates when CDA and/or N2 are the only gases to be sampled. 4 MET ONE Diffusers for CDA/Gas 5 Cleanrooms: Setting Alerts and Actions; Continuous Monitoring; Agenda • ISO 14644-1: Revisions • EU GMP ANNEX 1 • What affects Particle Concentration in a cleanroom • What can be readily controlled to affect concentration • What are the current trends and dialog that will likely change historic mainstays of cleanroom design • Setting ALERT and ACTION levels for best effect • Continuous monitoring for particle counts 7 Measuring Particles: 2 intentions Classification Monitoring Distribution of counts Uniform or Unique at each in a room or zone homogenous sample position Classification Monitoring 9 Monitoring 10 Two types of Monitoring !!! “EM” Intermittent Process Control • Daily, weekly, • Continuous during monthly, quarterly process/setup • General 1 to 3 • Frequent consecutive samples each time samples, often at 1- • Static or dynamic minute intervals • General need is to • Watching for show consistency heightened risk due over time – trend to contamination • CAUTION: • “Normal” operations Conditions and sources can cause brief must be identical to spikes in counts draw any conclusions 11 Setting ALERT and ACTION levels for best effect 12 Setting Warning Level(s) 1. Particle Count data sets are difficult to deal with • Often “0” is a target value • Cannot use common methods to establish range • Cannot use methods based on SD (Standard Deviation) 2. Normal activity must not cause a “false alarm” • How do readings change with normal operator actions? 13 Setting Warning Level(s) 3. May not wish to react on very first elevated value • Often need to wait for repeated occurrences – May be consecutive readings - or not 4. Decision of best method based related to understanding best indication of potential “loss of control” 14 Key Take-away #2 In very clean areas with low particle concentration: A) Particle counts can jump with normal activity and then return quickly to low values B) Avoiding nuisance alarms is important C) Generally cannot use common statistical strategies for setting ALERT and ACTION levels 15 Guidances for Aseptic Processing Pharmaceutical Industry Compliance Guidance – FDA cGMP Guidance for Industry • Sterile Drug Products Produced by Aseptic Processing – EU GMP Annex I (EMEA) • Manufacture of Sterile Medicinal Products EU GMP Annex 1 is more specific than FDA cGMP Guidance 16 Guidances for Aseptic Processing FDA joined PIC/s in January 2011 17 PIC/s Interpretation of Annex 1 "Monitoring, on the other hand, does not need to be performed according to EN ISO 14644-1 18 Setting Warning Level(s) You must understand your process !! PIC/s: A formal risk analysis study based on experiments and analysis of the monitoring data (over at least 6 month operation) should provide a basis for the determination of frequencies and limits. 19 Setting Warning Level(s) You must understand your process !! PIC/s: Frequencies and limits should be process-based and the results of the initial qualification and on going monitoring should be taken into account when setting operational alert and action limits. These limits and sample locations should be periodically reviewed for on-going validity of the risks initially considered. Those frequencies and limits should be process-based and the results of the qualification should be taken into account. 20 Setting Warning Level(s) 0.5 Particle Counts 100 100 90 80 70 60 50 50 0.5 Particle Counts 40 30 20 10 10 0 0 21 Setting Warning Level(s) 0.5 Particle Counts 100 100 90 80 70 60 50 50 0.5 Particle Counts 40 30 20 10 10 0 0 22 Setting Warning Level(s) 3 or more consecutive 0.5 Particle Counts 100 100 90 80 70 60 50 50 0.5 Particle Counts 40 30 20 10 10 0 0 23 Setting Warning Level(s) 3 or more in any 10-minute period 0.5 Particle Counts 100 100 90 80 70 60 50 50 0.5 Particle Counts 40 30 20 10 10 0 0 24 Setting Warning Level(s) 3 or more in any 10-minute period 0.5 Particle Counts 100 100 90 80 70 60 50 50 0.5 Particle Counts 40 30 20 10 10 0 0 25 Direct Connection to your Software for Online and Portable Monitoring Your System (SCADA, BMS, etc) Business network Met One Sensor network OPC Server Real-time data & control Software for Historical electronic data data collection Data from online sensors and translation Crystal Paper data & PDF files Reports Data from portables Standards-based connection to your preferred 3rd-party systems – Connect Met One devices to your preferred software (e.g. LIMS) – Built-in data storage and reports 26 Online and Portable Particle Counters MET ONE 6000P MET ONE 3400 Grade A & B automated monitoring Cleanroom classification to ISO14644 Internal vacuum pump Portable sampling for environmental validation MET ONE 6000 MET ONE 7000 Grade A & B automated monitoring Grade A & B automated monitoring Small and compact Sealed enclosure for wash down Automatic vacuum control 27 27 MET ONE 6000/7000 Online Sensors • Designed to meet ISO 21501 requirements • Built for sterile processing environments – VHP-resistant optics – automatic flow control – NEMA-rate enclosure (7000) • Built-in pump for fast installation and isolation (6000P) • Built-in user notification of all alarms • Multiple communication and installation options • External alarm and environmental sensor capabilities Featuring Long Life Laser™ technology 28 28 29 30 31 32 33 34 35 36 37 38 39 Two types of Monitoring !!! “EM” Intermittent Process Control • Daily, weekly, • Continuous during monthly, quarterly process/setup • General 1 to 3 • Frequent consecutive samples each time samples, often at 1- • Static or dynamic minute intervals • General need is to • Watching for show consistency heightened risk due over time – trend to contamination • CAUTION: • “Normal” operations Conditions and sources can cause brief must be identical to spikes in counts draw any conclusions 40 What can go wrong? A cleanroom or cleanzone usually starts out clean • What are my potential sources of contamination? – How can I eliminate, minimize or control them? • How does my room or zone remove particles? – In what direction(s)? – How fast? – How many occupants can be in there at one time? • Is my cleaning service effective? • How can I test or monitor to know I’m OK? Summary Cleanrooms are dynamic; particle concentrations change with location and with time Particle counts can fluctuate considerably but yet be normal Studying the actual particle count values over a long period of time is often critical to setting good values for ALERT and ACTION levels Strategies for setting ALERT and ACTION levels will likely be different for continuous PROCESS control versus intermittent EM sampling 42 Thank you ! [email protected] +1 541 295 7538 Presented by Grants Pass, Oregon USA Joe Gecsey Life Science Applications 43 Automation and Integration of Non-Viable Particle Monitoring Potential Levels of Automation 1. Data Acquisition (Instrument) – User-entered Descriptors – Methodology of sampling – Alarm reasons 2. Data Transmission – Rapid and accurate – Minimal User involvement – Error tracking / Transmission failure warnings – Formats readable by other software (LIMS, OPC, SCADA) 3. Data Mining or Analysis (Software) – Effective reports – Trends – Root cause / Basis for working on CAPA 45 45 Why ??? Data Information 46 Non-Viable Particle Monitoring via Paperless Automation & Integration of Monitoring 47 47 Eliminate Paper & Wasted Time Start / stop sampling File the print out Yes Tear the print out Review the 20 years of data paper storage Paste the printout to a Need to sheet retrieve data? Yes Are there excursions? Yes Yes Photocopy No or scan the print out Generate manual Manual reports retrieval Is data entry Enter data accurate?
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