Regulations Concerning AAiirrbboorrnnee PPaarrttiiccllee CCoouunnttiinngg Particle Counting AApppplliiccaattiioonnss Two types of activities performed with an airborne particle counter: EEnnvviirroonnmmeenntt Classification focuses primarily on the environment Monitoring focuses on process, people and the environment Process People People as a Contamination Source SShheedd 55 ttoo 1100 mmiilllliioonn sskkiinn cceellllss eeaacchh ddaayy 2000 to 5000 microorganisms/cm2 on skin Filter efficiency of clothing or garment varies greatly 2 Classification: FFSS220099 aanndd IISSOO 1144664444--11 ISO 14644-1 FED STD 209E Classification is the process of qualifying the cleanroom environment by the number of ISO Class English Metric particles using a standard method 1 2 DDetermiine cllassiiffiicatiion off room accorddiing to standards 3 1 M1.5 “ISO Class 5” or “Class 100” 4 10 M2.5 Performed on a regular basis but not frequently 6 months, yearly or ??? 5 100 M3.5 Standards define minimum number of sample points Usually based on area of cleanroom or clean zone 6 1,000 M4.5 Standards define minimum amount of air to be sampled 7 10,000 M5.5 Minimum volumes for statistically valid samples 8 100,000 M6.5 9 Classification is a standardized method 3 Environmental Monitoring Determine stability of room or zone over time; develop trend data EExxeeccuutteedd oonn aa sscchheedduulleedd bbaassiiss:: ddaaiillyy, wweeeekkllyy, mmoonntthhllyy Minimum number of sample points defined by QA – Area of cleanroom or clean zone – Activity – Risk to product Frequency and volume of sample points defined by QA – Frequent enough to show control – Frequent enough to provide meaningful trend information Not controlled by regulation…but need for trend information 4 Process Monitoring Determine readiness of room to carry out designated task PPeerrffoorrmmeedd wwhheenneevveerr rreelleevvaanntt aaccttiivviittyy ooccccuurrss – ddaaiillyy wwoorrkk Minimum number of sample points defined by QA AArea off clleanroom or cllean zone Activity Risk to product Frequency and volume of sample points defined by QA FFrequentt enoughh tto shhow conttroll Frequent enough to manage financial risk of product ccoonnttaammiinnaattiioonn NNot ddetermiinedd bby regullatiion…bbut bby riiskk!! 5 Differences Classification Monitoring Frequency 6 months or annual Daily, weekly, monthly or continuous NNuummbbeerr ooff ppoossiittiioonnss BByy ffoorrmmuullaa BByy nneeeedd ffoorr ddaattaa Sample volume By formula By need for data Pass/Fail criteria By table By need for trend info oorr ccoonnttrrooll Reporting format By standard In form needed for rapid understanding 6 Differences Classification Monitoring Distribution of counts Uniform or Unique at each in a room or zone homogenous sample position 7 Classification 8 Classification Standards for Airborne Particles General Air Monitoring Standards – before 1999 9 Classification Standards for Airborne Particles General Air Monitoring Standards – ISO 14644-1 • Classification of air cleanliness – ISO 14644-2 • Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 – IISSOO 1144664444-33 • Guidance on instrumentation to be used for testing for 1999 compliance with ISO 14644-1 ISO 14644 10