Usp Growth Promotion Of Media

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How To Establish Growth Promotion Tests For Pharmaceutical ...

(1 days ago) The United States Pharmacopeia (USP) Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments describes growth promotion testing as a procedure used “to demonstrate that media used in the microbiological environmental monitoring program, or in media-fill runs, are capable of supporting growth of indicator ...

https://www.pharmaceuticalonline.com/doc/how-to-establish-growth-promotion-tests-for-pharmaceutical-culture-media-0001

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<61> Microbiological Examination Of ... - USP–NF | USP-NF

(2 days ago) USP 31 Microbiological Tests / ... Growth Promotion of the Media GENERAL PROCEDURES Test each batch of ready-prepared medium and each batch of me-dium prepared either from dehydrated medium or from the ingredi-Carry out the determination under conditions designed to avoidents described.

https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter61.pdf

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Pharmaceutical Microbiology Manual

(6 days ago) A. Media B. Growth Promotion of the Media ... Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness ...

https://www.fda.gov/media/88801/download

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8 Best Practices for Growth Promotion Testing ...

(3 days ago) USP Chapter <62> states growth on the new batch of media should be “comparable” to growth on the previously approved batch. The new batch and the previously approved batch should be tested side-by-side. Read our 9 Tips for Growth Promotion Testing on Selective Media for more on this topic. 3.

https://blog.microbiologics.com/8-best-practices-for-growth-promotion-testing/

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Growth Promotion, Inhibition, Sterility and Indicative ...

(3 days ago) Growth Promotion test: Growth promotion test is used for the qualification of the media.We use different media for microbiology testing. But before using that media in any testing media must qualify GPT. In growth promotion test, media are inoculated with different kinds of microorganisms as mentioned in pharmacopoeia.

https://pharmapathway.com/growth-promotion-inhibition-sterility-indicative-test-acceptance-criteria/

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SOP on Media growth Promotion, Inhibition and Sterility ...

(1 days ago) SOP on Media growth Promotion, Inhibition and Sterility Check Objective To lay down the procedure for Media Growth Promotion, Inhibition and Sterility Check. Scope This SOP is applicable for Media Growth Promotion, Inhibition and Sterility Check in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory.

https://pharmaguidances.com/sop-on-media-growth-promotion-inhibition-and-sterility-check/

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FAQs: Microbial Examination of Nonsterile Products ... - USP

(2 days ago) The micro-organisms are to be added to the diluted/suspended product at the end of the preparation (usually a 1 in 10 dilution is prepared) or after the neutralization (in the last fraction of the rinsing fluid in the case of filtration or simultaneously with the preparation in/on the Petri dish in the case of the plate count method) if inhibition of growth by the sample cannot otherwise be ...

https://www.usp.org/frequently-asked-questions/microbial-examination-nonsterile-products-microbial-enumeration-tests

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<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES

(1 days ago) If the media preparation was not validated, then every batch of media would be subjected to growth-promotion testing. Test organisms may be selected from the appropriate compendial test chapter, based on the manufacturer's recommendation for a particular medium, or may include representative environmental isolates.

https://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1117.html

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Quality Control of Microbiological Culture Media

(2 days ago) Growth Promotion Testing of Broth Media Copious Growth. This is the current compendial method of choice. In this method, the challenge organism is inoculated at a very low level (< 100 CFU per unit) and incubated at the prescribed temperature for the prescribed period of time (3 days or 5 days).

http://microbiologynetwork.com/quality_control_of_microbiological_culture_media.asp

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Top Sites Have Usp Growth Promotion Of Media - Electronics ...

(1 months ago) Usp Media Growth Promotion Testing - get-coupon-codes.info. COUPON (12 days ago) An Inside Look at USP 71 - Kupiec. CODES (4 days ago) GROWTH PROMOTION, GROWTH MEDIA, AND TEST ORGANISMS Growth Promotion • For a valid sterility test, you must prove that the media used will grow bacteria and fungi.

https://couponbycell.com/usp-growth-promotion-of-media

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Growth Promotion Test Guide for Media Used in Microbial ...

(8 days ago) We thrive on creating innovative biological reference materials that make microbiologists' lives easier. Whether it's customized environmental isolate controls, process controls, certified reference materials, proficiency samples, or something that's never been done before -- we're up to the challenge.

https://www.microbiologics.com/Growth-Promotion-Test-Guide-for-Media-Used-in-Microbial-Enumeration-Tests

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Growth Promotion Testing For EM

(13 days ago) USP growth promotion testing requirements for solid and liquid microbiological growth media is described in <61> as: "For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardized inoculum.

https://www.pda.org/pda-letter-portal/home/full-article/growth-promotion-testing-for-em

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Growth Promotion Test (GPT) for Culture Media ...

(3 days ago) Growth Promotion Test (GPT) for Culture Media Growth promotion testing of the microbial culture media (solid and liquid) used in microbial analysis for nutrition quality using different microbial cultures as per USP and precautions taken during the GPT.

https://www.pharmaguideline.com/2011/01/growth-promotion-test.html

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7 Reasons Why Your Lab Should Perform Growth Promotion ...

(2 days ago) Problems can occur during shipping. The media may be exposed to extreme heat or cold when it is left on a truck without temperature control, a shipping dock or in customs. 3. Ensure a strain is grown at the correct temperature and under the correct atmospheric conditions. A failed growth promotion test can be caused by reasons other than poor ...

https://blog.microbiologics.com/7-reasons-why-your-lab-should-perform-growth-promotion-testing/

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SOP for Media Preparation and Growth Promotion Test ...

(2 days ago) 5.3 Growth promotion test of sterilized media. 5.3.1 Select the quantified microbial culture as per Annexure –I, for the growth promotion test 5.3.2 Quantified culture should be 24 hours old or a validated period old microbial culture can be used for growth promotion having count 10-100 cfu/ml..

https://www.pharmaguideline.com/2011/02/sop-for-media-preparation-and-growth.html

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<62> Microbiological Examination Of ... - USP–NF | USP-NF

(1 days ago) USP 31 Microbiological Tests / 〈62〉 Microbiological Examination1 〈62〉 MICROBIOLOGICAL Staphylococcus aureus such as ATCC 6538, NCIMB 9518, CIP 4.83, or NBRC EXAMINATION OF NONSTERILE 13276 Pseudomonas aeruginosa such as ATCC 9027, NCIMB PRODUCTS:TESTS FOR 8626, CIP 82.118, or NBRC 13275

https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter62.pdf

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Microbiological Best Laboratory Practices, USP <1117 ...

(2 days ago) The United States Pharmacopeia (USP), other global pharmacopeias and some parallel industry specific ... to provide additional general information on media growth promotion testing which led to a significant expansion in revision. ... parameters another issue, the potential of reduced growth promotion or selective activity of a medium.

http://microbiologynetwork.com/content/file/APR_May2011_Microbiological_Best_Laboratory_Practices_USP_1117.pdf

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Growth Promotion Test for Microbiological Media

(2 days ago) In growth promotion test, media are immunized with various types of microorganisms as specified in pharmacopeia. For instance broadly useful media like Soyabean casein digest agar (SCDA) and Nutrient agar (NA) are immunized with distinctive societies. In any case, for specific media specific microorganism is utilized for immunization as said as ...

http://www.articlesfactory.com/articles/education/growth-promotion-test-for-microbiological-media.html

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Growth Promotion Usp Guidelines - Free Coupon Codes

(17 days ago) (12 days ago) Usp Media Growth Promotion Testing - get-coupon-codes.info. COUPON (12 days ago) An Inside Look at USP 71 - Kupiec. CODES (4 days ago) GROWTH PROMOTION, GROWTH MEDIA, AND TEST ORGANISMS Growth Promotion • For a valid sterility test, you must prove that the media used will grow bacteria and fungi.

https://www.get-coupon-codes.info/growth-promotion-usp-guidelines/

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SOP for Growth Promotion Test of Microbiological media ...

(3 days ago) To lay down a procedure to check growth promotion test of different media used for Microbiological analysis. 2.0 Scope: This procedure is applicable for growth promotion test in microbiology Laboratory.

https://www.pharmasopcorner.net/2016/06/sop-growth-promotion-test-microbiological-media.html

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An Inside Look at USP 71 - Kupiec

(2 days ago) GROWTH PROMOTION, GROWTH MEDIA, AND TEST ORGANISMS Growth Promotion • For a valid sterility test, you must prove that the media used will grow bacteria and fungi. • Growth promotion is not a test of a drug product. • Each lot or batch of media must have a growth promotion performed. • < 100 cfu of each of the 6 USP <71> organism into ...

http://westernpharmacyexchange.com/wp-content/uploads/2018/04/An-Inside-Look-at-USP.pdf

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Growth Promotion Testing of Cultured Media | Bioclin ...

(8 days ago) Growth promotion testing consists of three types of tests: Quantitative Analysis:Used for media that is used for enumeration testing i.e. Tryptone soya agar, Place Count agar etc. Recovery specification applied is 50-200% recovery when the new batch (Test) is compared to a previously certified batch (Control).

https://bioclinlabs.com/growth-promotion-testing-of-cultured-media/

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Usp Growth Promotion Of Media - Free Coupon Codes

(19 days ago) 9 Tips for Growth Promotion Testing on Selective Media ... CODES (2 days ago) The U.S. Pharmacopeia (USP) created quite the challenge when it designed the growth promotion test (GPT) for selective media. Laboratories not only need to test new batches of media with less than 100 colony-forming units (CFU), the colonies must also grow on agars such as MacConkey within 18 hours.

https://www.get-coupon-codes.info/usp-growth-promotion-of-media/

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FDA ISSUES - MEDIA GROWTH PROMOTION STUDIES McNEIL-PPC ...

(12 days ago) FDA ISSUES — MEDIA GROWTH  PROMOTION STUDIES McNEIL-PPC, DELTEX PHARMA, RIBBON PHARMA & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER Comment Comments Regarding Proposed Changes to USP General Chapter <823> Radiopharmaceuticals for Positron Emission Tomography-Compounding were recently made to the USP as they move forward in their decision process. One of the sections dealt with ...

https://www.barryafriedmanphdllc.com/2011/04/07/fda-issues-media-growth-promotion-studies-mcneil-ppc-deltex-pharma-ribbon-pharma-chemical-columbia-presbyterian-medical-center/

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2.6. BIOLOGICAL TESTS - uspbpep.com

(3 days ago) The media used comply with the following tests, carried out before or in parallel with the test on the product to be examined. Sterility. Incubate portions of the media for 14 days. No growth of micro-organisms occurs. Growth promotion test of aerobes, anaerobes and fungi. Test each batch of ready-prepared medium and each batch

http://www.uspbpep.com/ep60/2.6.%201.%20sterility%2020601e.pdf

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BD Tryptic Soy Broth (TSB)

(1 days ago) its capacity for growth promotion, this formulation was adopted by The United States Pharmacopeia (USP) and the European Pharmacopeia (EP) as a sterility test medium.3,4 In clinical microbiology, the medium is used in a variety of procedures, e.g., for the preparation

https://legacy.bd.com/europe/regulatory/Assets/IFU/HB/CE/BA/BA-257107.pdf

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USP Growth Promotion – NAMSA

(1 days ago) USP Growth Promotion. Categories. QC/ Sterility Assurance - Microbiology Validation Standards. USP Growth Promotion Testing of Culture Media – Liquid or Plated. Test Options/Variations. MG044-000: Liquids: MG044-001: Agar: Careers; Accreditations & Certifications; Site Map ...

https://namsa.com/tests/usp-growth-promotion-liquids/

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Promotion Test Guide for EZ CFU™, EZ CFU™ and EZ

(4 days ago) The Growth Promotion Test (GPT) is an important function in the United States (USP), European (Ph. Eur.) and Japanese (JP) Pharmacopeias. Its purpose is to determine the suitability of media used in pharmaceutical tests. This Technical Information Bulletin (TIB) discusses the basic requirements of the GPT and explains how to perform the test ...

https://www.chemie-brunschwig.ch/documents/suppliers-information/pdf/downloads/MI_AccushotTIB264.pdf

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Tryptic Soy Agar (TSA), USP

(4 days ago) For growth promotion, enumeration, or sterility testing procedures, consult USP <61>, <62>, or <71>. Because of the inherent variability of environmental sampling methods, it is more useful to trend contamination recovery results rather than focus on the number of colonies recovered from a single sample.

https://catalog.hardydiagnostics.com/cp_prod/Content/hugo/TrypticSoyAgarMediaUSP.html

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General Chapters: <1116> MICROBIOLOGICAL EVALUATION OF ...

(2 days ago) Media Growth Promotion —Procedure that references Growth Promotion under Sterility Tests 71 to demonstrate that media used in the microbiological environmental monitoring program, or in media-fill runs, are capable of supporting growth of indicator microorganisms and of environmental isolates from samples obtained through the monitoring ...

http://ftp.uspbpep.com/v29240/usp29nf24s0_c1116.html

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Media Fills for Validation of Aseptic Preparations for ...

(2 months ago) A growth promotion test ensures that the medium used in the media fill will support the growth of contaminating microorganisms. This is an essential control for media fills because the desired

https://www.fda.gov/media/81974/download

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11/21/2016 33(2) Second Interim Revision ... - USP

(1 days ago) Growth Promotion Suitability of Counting Method ... For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardized inoculum. For a freshly prepared inoculum, growth of the microorganisms comparable to that previously obtained with a previously tested and approved batch of medium occurs. ...

https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/q05b_pf_ira_33_2_2007.pdf

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The Growth Promotion Test

(2 days ago) The pharmacopeia says, “For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardized inoculum” The value of the standardized inoculum is obtained by counting the number of colonies on the previously approved media Perform side-by-side testing for direct

http://www.bdcint.com.do/wp-content/uploads/2018/10/PPT106-GPT-Rev-D-.pdf

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Facts about Environmental Isolates and Growth Promotion ...

(9 days ago) Growth Promotion and EI. USP <61> states that “seed-lot culture maintenance techniques (seedlot systems) are used so that the viable microorganisms used for inoculation are not more than five passages removed from the original master seed-lot”. 7 Therein microorganisms used in growth-promotion testing may be based on the manufacturer’s ...

http://www.americanpharmaceuticalreview.com/Featured-Articles/359629-Facts-about-Environmental-Isolates-and-Growth-Promotion-Test/

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General Chapters: <71> STERILITY TESTS

(3 days ago) Prepare media for the tests as described below, or dehydrated formulations may be used provided that, when reconstituted as directed by the manufacturer or distributor, they meet the requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Media are sterilized using a validated process.

http://pharmacopeia.cn/v29240/usp29nf24s0_c71.html

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USP <1116> and its Implications for Measuring Microbial ...

(2 days ago) The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic processing environments (1). Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is ...

https://www.pda.org/pda-europe/news-archive/full-story/2015/05/27/usp-1116-and-its-implications-for-measuring-microbial-recovery-rates

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Culture Media for Compendial Methods | Sigma-Aldrich

(5 days ago) In addition, the 2016 edition of the Chinese Pharmacopoeia is, for the most part, harmonized in terms of media composition and performance criteria, although growth promotion testing is required to be performed with strains from the Chinese strain collection.

https://www.sigmaaldrich.com/analytical-chromatography/microbiology/bioburden/culture-media-for-compendial-methods.html

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Microbial Enumeration Tests | Pharmaceutical Testing USP 61

(2 days ago) USP <61> lists several potential neutralizing agents, based on the offending interfering substance. ... used to demonstrate suitability of the dilution and enrichment method are the same organisms used to demonstrate the growth promotion ability of media used in the test. Specifically: Pseudomonas aeruginosa.

https://focus-lab.com/usp_61_nonsterile_product_microbial_enumeration.html

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<71> STERILITY TESTS

(2 days ago) 70 〈71〉 Sterility Tests / Microbiological Tests USP 35 Fluid Thioglycollate Medium is to be incubated at 30°–35°. Table 1. Strains of the Test Microorganisms Suitable for Use in For products containing a mercurial preservative that cannot the Growth Promotion Test and the Method Suitability be tested by the membrane filtration method, Fluid Thiog-Test (Continued)

https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/0069-0074%20%5b71%5d%20STERILITY%20TESTS.pdf

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Usp Growth Promotion Procedure - Top Types Of Voucher

(10 days ago) (3 days ago) The United States Pharmacopeia (USP) Chapter . 1116> Microbiological Control and Monitoring of Aseptic Processing Environments describes growth promotion testing as a procedure used “to demonstrate that media used in the microbiological environmental monitoring program, or in media-fill runs, are capable of supporting growth of ...

https://gettravelvoucher.com/usp-growth-promotion-procedure

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Assessment of Culture Media in Pharmaceutical Microbiology ...

(1 days ago) Culture media is of fundamental importance for most microbiological tests: to obtain pure cultures, to grow and count microbial cells, and to cultivate and select microorganisms. Without high-quality media, the possibility of achieving accurate, reproducible, and repeatable microbiological test results is reduced [1]. A microbiological culture medium is a substance that encourages the growth ...

http://www.americanpharmaceuticalreview.com/Featured-Articles/163589-Assessment-of-Culture-Media-in-Pharmaceutical-Microbiology/

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Growth Promotion Test Usp 51 ⇒ 2020

(1 months ago) Save Growth Promotion Test Guide for EZ‐CFU™, EZ‐CFU™ One Step, and EZ‐Accu Shot™ TIB.264 Revision 2010.FEB.01 Page 1 of 13 Introduction The Growth Promotion Test (GPT) is an important function in the United States (USP), European (Ph. Eur.) and Japanese

https://www.divi-discounts.com/growth-promotion-test-usp-51/

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Environmental Monitoring Supplies (Air & Water)

(11 days ago) For confirmation testing on commercially prepared media, Nelson Labs provides growth promotion testing services following USP and EP guidelines. Water Sampling Bottles For sampling water, we recommend start, mid, and end run sampling for routine process monitoring to assess water over time in a controlled environment or manufacturing process.

https://www.nelsonlabs.com/testing/environmental-monitoring-supplies-air-water/

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Standards and Guidelines: JP, USP, Test Method: Growth ...

(5 days ago) We thrive on creating innovative biological reference materials that make microbiologists' lives easier. Whether it's customized environmental isolate controls, process controls, certified reference materials, proficiency samples, or something that's never been done before -- we're up to the challenge.

https://www.microbiologics.com/standards-guidelines/JP,USP/testmethod/Growth-Promotion-Testing

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ARL Bio Pharma

(5 days ago) Meets FDA and USP microbiological growth media requirements; Verifies media vendor's certificate of analysis; ARL has a new submission form specific for "Growth Promotion" tests. This new form is a quick selection form for media types, organism tests, and incubation time and temperature.

https://www.arlok.com/node

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Aseptic Process Simulation - USP

(3 days ago) etc. or bulk media are collected and incubated for 14 days at an appropriate temperature (typically 7 days at 20-25°C and 7 days at 30–35°C). If there is no growth, the media are tested for growth pro-motion using standard test organisms plus routine environmental organisms. On successful growth promotion, the aseptic process simulation can be

https://edisciplinas.usp.br/pluginfile.php/2135398/mod_resource/content/1/Aseptic%20Process%20Simulation.pdf

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