[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-398717-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-398717-en":130},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","physical-and-biological-collection-efficiencies-application-note-cc-127","PHYSICAL AND BIOLOGICAL COLLECTION EFFICIENCIES - Application Note CC-127","","Guidance for microbial air sampling in pharmaceutical cleanrooms under GMP focuses on active air samplers and the need for correct performance characterization. The note distinguishes physical efficiency from biological efficiency, explaining how sampler design and sampling stress/dehydration affect viability and CFU recovery. It summarizes recognized standards and describes the d50 value, impaction cut point, and impaction velocity considerations. It then presents testing performed for the TSI AeroTrak+ Remote AAS Model 7010, including experimental procedures and complete d50 results.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/physical-and-biological-collection-efficiencies-application-note-cc-127/398717/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/physical-and-biological-collection-efficiencies-application-note-cc-127/398717.png","ImageObject",300,407,{"name":42,"@type":43},"Anna Hans","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-30","2026-09-27",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",5,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the difference between physical efficiency and biological efficiency for an AAS?","Question",{"text":63,"@type":64},"Physical efficiency describes how well the sampler collects particles by size, independent of whether they are viable. Biological efficiency describes how well it collects viable microbe-bearing particles that can form CFUs, accounting for losses from physical capture and reduced viability during sampling and media dehydration.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What does the d50 value represent for air sampler performance?",{"text":68,"@type":64},"The d50 value is the aerodynamic equivalent particle size at which 50% of particles are collected and 50% pass by the culture medium. A lower d50 indicates higher efficiency at capturing smaller particles.",{"name":70,"@type":61,"acceptedAnswer":71},"How does impaction velocity influence the d50 value and particle capture?",{"text":72,"@type":64},"Impaction velocity is the maximum air/particle velocity at the nozzles that larger particles can carry to impact the culture medium. Higher impaction velocity captures smaller particle sizes but can stress and damage viable particles; lower velocity may fail to capture viable particles effectively.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},398717,1791414706,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,100,105,109,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},"Comic",60,"comic",{"id":101,"doc_module":4,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},6,"Technology",50,"technology",{"id":106,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":107,"slug":108},7,40,"healthcare",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},8,"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":55,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":106,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":115,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":144,"preview_page_count":4},5909892332657,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","PHYSICAL AND BIOLOGICAL COLLECTION EFFICIENCIES  \nTSI AEROTRAK+ REMOTE ACTIVE AIR SAMPLER  \nMODEL 7010  \nAPPLICATION NOTE CC-127 (5/6/2021) Rev B (A4)  \nContents  \nIntroduction—Microbial Air Sampling for Pharma .................................................................................. 1  \nBackground—Evaluating Air Samplers ......................................................................................................... 2  \nCalculation of the d50 Value—Proof in Testing............................................................................................ 4  \nTest Procedures for the Experimental Determination of the d50 Value ..............................................4  \nExperimental d50 Value Results............................................................................................................................ 7  \nConclusions—Meet the Needs of Pharma Aseptic Processing............................................................... 8  \nReferences................................................................................................................................................................ 9  \nIntroduction—Microbial Air Sampling for Pharma  \nAs part of good manufacturing practice (GMP) compliance, medical and pharmaceutical manufacturing operations must qualify and routinely monitor microbial contamination levels in cleanrooms and clean spaces such as isolators and restricted access barrier systems (RABS) . The use of active air samplers (AASs) is an essential part of this process.  \nEven though impaction-based microbial samplers have been in use since the middle of the 20th century, currently there is no standard defining minimum performance requirements. As a result, there are significant differences in performance for AASs in use today, which can lead to improper evaluation of cleanroom microbial contamination levels. Therefore, proper characterization of microbial air sampler performance is a critical aspect of a contamination control program.  \nWhile no standards currently define minimum performance levels for AASs, ISO 14698-11 and EN 17141:20202 (which is scheduled to replace ISO 14698-1) provide recognized guidance regarding active air sampling equipment and validation. These standards describe two ways to evaluate the collection efficiency of microbial air samplers: physical efficiency and biological efficiency.  \nPhysical efficiency defines how well the sampler collects different sizes of particles, regardless of the composition of the particles (inanimate, microorganisms, or microbe-bearing) . The biological efficiency defines how well the sampler collects viable microbe-bearing particles which can form colony-forming unit (CFU). It includes the losses caused by both the physical efficiency and the effect that the sampling has on the viability of the microorganisms due to stressing during collection and dehydration of the media.  \nWhile physical efficiency can be measured using biological particles, often it is measured using polystyrene latex spheres (PSL) or other non-viable particles. Biological efficiency is measured using microbes. Annex E of EN 17141 provides a formula to calculate the d50 value, or physical efficiency, for AASs using impaction. In addition, Annex B of ISO 14698-1 and Annex E of EN 17141 define procedures that can be used to measure the physical and biological efficiency of a sampler.  \nTSI recently introduced a new AAS—the TSI AeroTrak®+ Remote Active Air Sampler (AAS) Model 7010. It uses external vacuum to draw air through the AAS. With an impaction velocity of 43 m/s, the AAS is designed to provide high physical and biological efficiency over a broad range of particle sizes. This document describes testing that was done to determine the performance of AeroTrak+ Remote AAS, and includes complete test results.  \nBackground—Evaluating Air Samplers  \nThe efficiency of a sampler can be defined as the number of particles captured in the sampler div","cbCaijCMmpUyiGy9","https://ap.wps.com/l/cbCaijCMmpUyiGy9","pdf",634136,"English","# Introduction—Microbial Air Sampling for Pharma\n## Background—Evaluating Air Samplers\n## Calculation of the d50 Value—Proof in Testing\n## Test Procedures for the Experimental Determination of the d50 Value\n## Experimental d50 Value Results\n## Conclusions—Meet the Needs of Pharma Aseptic Processing\n## References","[{\"question\":\"What is the difference between physical efficiency and biological efficiency for an AAS?\",\"answer\":\"Physical efficiency describes how well the sampler collects particles by size, independent of whether they are viable. Biological efficiency describes how well it collects viable microbe-bearing particles that can form CFUs, accounting for losses from physical capture and reduced viability during sampling and media dehydration.\"},{\"question\":\"What does the d50 value represent for air sampler performance?\",\"answer\":\"The d50 value is the aerodynamic equivalent particle size at which 50% of particles are collected and 50% pass by the culture medium. A lower d50 indicates higher efficiency at capturing smaller particles.\"},{\"question\":\"How does impaction velocity influence the d50 value and particle capture?\",\"answer\":\"Impaction velocity is the maximum air/particle velocity at the nozzles that larger particles can carry to impact the culture medium. Higher impaction velocity captures smaller particle sizes but can stress and damage viable particles; lower velocity may fail to capture viable particles effectively.\"}]","PHYSICAL AND BIOLOGICAL COLLECTION EFFICIENCIES - Application Note CC-127 | PDF",1790488483,23]