[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-297505-105":59,"doc-detail-297505-en":131},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":124,"head_meta":126,"extra_data":128,"updated_unix":130},105,"en","reviewing-certificates-of-analysis-for-microbiological-media-tsa-and-tsb-newsletter-issue-august-2025","Reviewing Certificates of Analysis for Microbiological Media: TSA and TSB - Newsletter Issue - August 2025","","Newsletter covers how to review certificates of analysis for microbiological media, focusing on tryptic soy agar (TSA) and tryptic soy broth (TSB). It details key COA elements to verify, including manufacturing and expiry dates, visual characteristics, pH ranges, growth promotion acceptance criteria with listed organisms, and sterility evidence. When irradiation applies, it explains dose and irradiation date checks. It also provides recommendations for assigning responsibility, using standardized checklists, signing and dating reviews, and storing COAs in paper or electronic systems to support compliance and reliable quality systems.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/reviewing-certificates-of-analysis-for-microbiological-media-tsa-and-tsb-newsletter-issue-august-2025/297505/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/reviewing-certificates-of-analysis-for-microbiological-media-tsa-and-tsb-newsletter-issue-august-2025/297505.png","ImageObject",300,407,{"name":92,"@type":93},"Jiven","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-25","2026-09-18",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",13,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"Which dates should be checked on a COA for TSA and TSB?","Question",{"text":113,"@type":114},"Verify manufacturing date, expiration date, date of sterilization or irradiation (if applicable), and the certificate date, then confirm the timeline is logical and matches the manufacturer’s stability data.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What visual and physical characteristics should be reviewed on the COA and upon receipt?",{"text":118,"@type":114},"Review appearance details such as color, clarity, precipitation/condensation, and packaging integrity; when received, confirm the product matches the COA and quarantine if you observe cloudiness, cracks, dehydration, or contamination.",{"name":120,"@type":111,"acceptedAnswer":121},"Why is growth promotion testing critical when reviewing a COA?",{"text":122,"@type":114},"Growth promotion demonstrates the media can recover low levels of specified organisms. The COA should list the organisms tested, acceptance criteria, and results, and lack of lot-specific data is a sign to change suppliers.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},297505,1790164489,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":29,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},1099513958607,"https://ap-avatar.wpscdn.com/avatar/100002390cf8733938c?x-image-process=image/resize,m_fixed,w_180,h_180&k=1778829742770036399","NEWSLETTER ISSUE: AUGUST 2025  \nReviewing Certificates of Analysis for Microbiological Media: TSA and TSB  \nIn any sterile compounding operation, tryptic soy agar (TSA) and tryptic soy broth (TSB) are foundational tools used for environmental monitoring, sterility testing, and media fills. However, their effectiveness—and regulatory defensibility—depends on more than just purchasing from a reputable supplier. A critical step is thoroughly reviewing the certificate of analysis ( COA) for each lot to confirm suitability before use. Below, we’ ll cover the essential elements you should verify, best practices for documentation, and tips for COA storage.  \nKey Elements to Review on the COA  \n1. Dates  \nCarefully check and reconcile all dates on the certificate:  \n Manufacturing date  \n Expiration date  \n Date of sterilization or irradiation (if applicable)  \n Certificate date  \nMake sure these dates are logical (e.g., the manufacturing date precedes the expiration date, and any sterilization or irradiation occurred prior to release) . The shelf life should be consistent with the manufacturer’s stated stability data.  \nIf any date looks inconsistent, contact the manufacturer for clarification before use. We have seen date errors on COAs in the past.  \nNEWSLETTER ISSUE: AUG 2025  \n2. Visual Characteristics  \nThe COA should list:  \n Appearance ( color, clarity, presence or absence of precipitation, condensation)  \n Media fill level (for pre-filled plates or tubes)  \n Packaging integrity  \nVerify that the actual product matches the description in the COA when you receive it if possible. Depending on the packaging of the TSA plates, this may not be possible. If this is the case, train staff to verify that the media looks acceptable at the time of use. If you notice cloudiness, cracks, dehydration, or contamination, quarantine the lot, contact the manufacturer, and investigate. Be sure to thoroughly document the investigation.  \n3. pH  \nAcceptable pH ranges are typically specified, for example:  \n TSA: 7.3 ±0 .2  \n TSB: 7.3 ±0 .2  \nThe pH must be tested by the manufacturer as part of release criteria and documented on the COA. pH outside of range can compromise growth promotion or inhibit recovery of organisms.  \n4. Growth Promotion  \nOne of the most critical aspects of media quality control is growth promotion testing, which demonstrates that the media can recover low levels of specified microorganisms. The COA should document:  \n the organisms tested (for TSA and TSB: Staphylococcus aureus, Pseudomonas paraeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis)  \n the acceptance criteria ( usually specified recovery within a given range)  \n results of the test  \nIf your media supplier does not provide growth promotion data for each lot, it’s time to find another supplier.  \nNEWSLETTER ISSUE: AUG 2025  \n5. Sterility  \nFor sterile media, the COA should indicate:  \n a confirmed absence of contamination ( no growth during the incubation period)  \n the methods used to test sterility  \nThis is essential for applications such as sterility testing or media-fill simulations.  \n6. Irradiation (if applicable)  \nIf your media is irradiated ( common with gammairradiated TSA plates) , the COA should state:  \n the irradiation dose  \n the date of irradiation  \n confirmation that irradiation achieved sterility without compromising growth promotion  \nRecommendations for Reviewing and Approving COAs  \n1. Assign responsibility  \n Designate a qualified individual (e.g., designated person, trained staff member) to review each COA before release of the media for use.  \n2. Use a standardized checklist  \n Many facilities develop areview checklist or SOP covering:  \n lot number match to  \nreceived inventory  \n verification of all dates  \n pH confirmation  \n growth promotion and sterility results  \n irradiation records (if applicable)  \n visual inspection upon receipt  \nNEWSLETTER ISSUE: AUG 2025  \n2. Sign and date  \n It is best practice to doc","cbCaidwDk5UxloeE","https://ap.wps.com/l/cbCaidwDk5UxloeE","pdf",942719,"English","# Key Elements to Review on the COA\n## Dates\n## Visual Characteristics\n## pH\n## Growth Promotion\n## Sterility\n## Irradiation (if applicable)\n# Recommendations for Reviewing and Approving COAs\n## Assign responsibility\n## Use a standardized checklist\n## Sign and date\n# Storage of COAs\n## Paper-Based\n## Electronic\n# Final Thoughts","[{\"question\":\"Which dates should be checked on a COA for TSA and TSB?\",\"answer\":\"Verify manufacturing date, expiration date, date of sterilization or irradiation (if applicable), and the certificate date, then confirm the timeline is logical and matches the manufacturer’s stability data.\"},{\"question\":\"What visual and physical characteristics should be reviewed on the COA and upon receipt?\",\"answer\":\"Review appearance details such as color, clarity, precipitation/condensation, and packaging integrity; when received, confirm the product matches the COA and quarantine if you observe cloudiness, cracks, dehydration, or contamination.\"},{\"question\":\"Why is growth promotion testing critical when reviewing a COA?\",\"answer\":\"Growth promotion demonstrates the media can recover low levels of specified organisms. The COA should list the organisms tested, acceptance criteria, and results, and lack of lot-specific data is a sign to change suppliers.\"}]","Reviewing Certificates of Analysis for Microbiological Media: TSA and TSB - Newsletter Issue - August 2025 | PDF",1789745117,15]