{"id":8751,"date":"2026-03-27T16:52:15","date_gmt":"2026-03-27T16:52:15","guid":{"rendered":"https:\/\/www.vanguardhealthcare.co.uk\/?post_type=facilities&p=8433"},"modified":"2026-06-02T10:47:54","modified_gmt":"2026-06-02T10:47:54","slug":"cleanrooms-laboratories-and-containment-facilities","status":"publish","type":"facilities","link":"https:\/\/www.vanguardlifesciences.co.uk\/cy_gb-wls\/facilities\/cleanrooms-laboratories-and-containment-facilities\/","title":{"rendered":"Profi a Dilysu"},"content":{"rendered":"
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Gwasanaethau Profi a Dilysu<\/h2>\n
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Mae Vanguard Life Sciences, mewn cydweithrediad ag Enbloc, yn darparu gwasanaethau profi a dilysu ystafelloedd gl\u00e2n cynhwysfawr ar gyfer amgylcheddau gwyddorau bywyd rheoleiddiedig ledled y DU.<\/p>\n

Mae ein peirianwyr dilysu profiadol yn cefnogi ystafelloedd gl\u00e2n, ystafelloedd cynnwys, cypyrddau diogelwch microbiolegol, cypyrddau llif laminar ac offer cysylltiedig, gan gynnwys oergelloedd a rhewgelloedd. Cynhelir yr holl brofion yn unol \u00e2 BS EN ISO 14644 a gofynion cGMP yr UE, gan sicrhau bod eich cyfleuster yn bodloni'r safonau cydymffurfio a pherfformiad uchaf.<\/p>\n<\/div>\n<\/div>\n

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Dilysu cyflawn ar gyfer amgylcheddau rheoleiddiedig<\/h2>\n
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Mae profi a dilysu yn hanfodol i gynnal uniondeb cynnyrch, sicrhau diogelwch cleifion a chyflawni cydymffurfiaeth reoleiddiol. Mae ein dull strwythuredig yn darparu tystiolaeth glir, archwiliadwy bod eich cyfleuster yn gweithredu o fewn paramedrau diffiniedig.<\/p>\n

Drwy ein cydweithrediad ag Enbloc, rydym yn cyfuno arbenigedd dylunio, adeiladu a dilysu i ddarparu gwasanaeth di-dor, o'r dechrau i'r diwedd, gyda'r amhariad lleiaf posibl ar eich gweithrediadau.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n

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Datblygu a gweithredu protocol dilysu<\/h2>\n
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Rydym yn cefnogi'r cylch bywyd dilysu llawn, gan gynnwys datblygu a gweithredu protocolau allweddol:<\/p>\n

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  • Manylebau Gofynion Defnyddiwr (URS)<\/li>\n
  • Profi Derbyn Ffatri (FAT)<\/li>\n
  • Profi Derbyn Safle (SAT)<\/li>\n
  • Cymhwyster Dylunio (DQ)<\/li>\n
  • Cymhwyster Gosod (IQ)<\/li>\n
  • Cymhwyster Perfformiad (PQ)<\/li>\n<\/ul>\n

    Mae hyn yn sicrhau bod eich cynllun meistr dilysu yn cael ei ddilyn a'i ddogfennu'n llawn o'r dyluniad cychwynnol hyd at berfformiad gweithredol.<\/p>\n<\/div>\n<\/div>\n

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    Galluoedd profi ystafell l\u00e2n<\/h2>\n
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    Mae ein gwasanaethau profi a dilysu ystafelloedd gl\u00e2n yn cynnwys:<\/p>\n

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    • Profi cyfanrwydd hidlydd HEPA (profi DOP)<\/li>\n
    • Cyfrif gronynnau i safonau ISO 14644 a cGMP yr UE<\/li>\n
    • Mesur llif aer cyfeintiol a chyfradd newid aer<\/li>\n
    • Profi gwahaniaethol pwysau<\/li>\n
    • Profi cyfradd glanhau ac adfer<\/li>\n
    • Astudiaethau delweddu llif aer<\/li>\n<\/ul>\n

      Caiff yr holl brofion eu cynnal gan beirianwyr sydd wedi'u hyfforddi gan y CTCB sydd \u00e2 phrofiad helaeth ar y safle mewn gwyddorau bywyd ac amgylcheddau gofal iechyd.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n

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      Mapio tymheredd a lleithder<\/h2>\n
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      Rydym yn darparu mapio tymheredd a lleithder ar y safle ar gyfer ystafelloedd gl\u00e2n a gwasanaethau cysylltiedig o unrhyw raddfa, o unedau storio bach i gyfleusterau mawr sy'n fwy na 2,000m\u00b2.<\/p>\n

      Gan ddefnyddio meddalwedd mapio arbenigol a chofnodwyr data wedi'u graddnodi, rydym yn darparu data amgylcheddol cywir a dibynadwy. Rydym hefyd yn cefnogi ail-ddilysu cyfnodol i sicrhau bod eich cyfleuster yn parhau i berfformio yn unol \u00e2 manylebau dylunio.<\/p>\n<\/div>\n<\/div>\n

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      Cabinet diogelwch microbiolegol a dilysu llif laminar<\/h2>\n
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      Mae cypyrddau diogelwch microbiolegol a chypyrddau llif laminar yn gydrannau hanfodol o lawer o brosesau ystafelloedd gl\u00e2n.<\/p>\n

      Mae ein peirianwyr wedi'u hyfforddi'n llawn i gynnal profion, comisiynu a chydymffurfiaeth barhaus ar gyfer cypyrddau Dosbarth I, II a III, yn ogystal \u00e2 systemau llif laminar. Drwy integreiddio'r gwasanaeth hwn \u00e2 dilysu ystafelloedd gl\u00e2n, rydym yn lleihau amser segur ac yn dileu'r angen am gontractwyr lluosog.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n

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      Monitro amgylcheddol<\/h2>\n
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      Mae monitro amgylcheddol yn ofyniad allweddol o dan Atodiad 1 cGMP.<\/p>\n

      Rydym yn darparu:<\/p>\n

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      • Profi pl\u00e2t setlo<\/li>\n
      • Profi pl\u00e2t cyswllt<\/li>\n
      • Samplu aer gweithredol<\/li>\n<\/ul>\n

        Drwy ein partneriaid labordy, rydym yn sicrhau bod canlyniadau'n cael eu prosesu'n gyflym ac yn adrodd yn glir i gefnogi eich prosesau ansawdd a chydymffurfiaeth.<\/p>\n<\/div>\n<\/div>\n

        \"\"<\/div>\n<\/div>\n<\/div>\n<\/section>","protected":false},"featured_media":8648,"template":"","format":"standard","meta":{"_acf_changed":false},"facility-type":[],"class_list":["post-8751","facilities","type-facilities","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nTesting & Validation - Vanguard Life Sciences<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vanguardlifesciences.co.uk\/cy_gb-wls\/facilities\/cleanrooms-laboratories-and-containment-facilities\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Testing & Validation - Vanguard Life Sciences\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.vanguardlifesciences.co.uk\/cy_gb-wls\/facilities\/cleanrooms-laboratories-and-containment-facilities\/\" \/>\n<meta property=\"og:site_name\" content=\"Vanguard Life Sciences\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-02T10:47:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2026\/02\/10-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"795\" \/>\n\t<meta property=\"og:image:height\" content=\"577\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 munud\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.vanguardlifesciences.co.uk\\\/facilities\\\/cleanrooms-laboratories-and-containment-facilities\\\/\",\"url\":\"https:\\\/\\\/www.vanguardlifesciences.co.uk\\\/facilities\\\/cleanrooms-laboratories-and-containment-facilities\\\/\",\"name\":\"Testing & Validation - 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