\u00een conformitate cu FDA 21 CFR Partea 11<\/strong> \u00een noua noastr\u0103 carte alb\u0103!<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.5″ background_color=”#61AC7B” background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”|10px||10px|false|true” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.5″ text_font_size=”18px” header_3_font=”||||||||” background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_margin=”||80px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|tablet” locked=”off” global_colors_info=”{}”]<\/p>\n
![\"m\u0103surarea](\"https:\/\/hunterlab.de\/wp-content\/uploads\/2024\/04\/Whitepaper-Farbmessung-nach-21-CFR-Part-11-w-1920w-243x300.png\")
<\/p>\n
Whitepaper: „M\u0103surarea culorilor conform FDA”:<\/h3>\n
Citi\u021bi totul despre validare \u0219i conformitate \u00een m\u0103surarea culorilor \u00een ultima noastr\u0103 carte alb\u0103 \u0219i \u00een revista HunterLab NEWS despre cum s\u0103 m\u0103sura\u021bi \u00een mod fiabil cantit\u0103\u021bi foarte mici de probe lichide \u0219i la ce s\u0103 fi\u021bi aten\u021bi \u00een ceea ce prive\u0219te manipularea probelor.<\/p>\n
V\u0103 rug\u0103m s\u0103 completa\u021bi cele dou\u0103 c\u00e2mpuri de mai jos \u0219i v\u0103 vom trimite materialul de lectur\u0103 \u00een format PDF!<\/em><\/span><\/p>\n[\/et_pb_text][df_gravity_form gravity_forms=”22″ use_ajax=”on” input_padding=”15px||15px||true|false” button_align=”center” button_background_bgcolor=”#2A4175″ button_padding=”15px|20px|15px|20px|true|true” _builder_version=”4.27.4″ _module_preset=”default” button_font=”|700|||||||” button_text_color=”#FFFFFF” button_font_size=”16px” custom_css_main_element=”.gform_wrapper.gravity-theme .gfield input.large, .gform_wrapper.gravity-theme .gfield select.large {|| width: 100%;|| padding-top: 15px;|| padding-bottom: 15px;|| border-radius: 5px;||}” border_radii_input=”on|5px|5px|5px|5px” border_radii_textarea=”on|5px|5px|5px|5px” border_radii_button=”on|5px|5px|5px|5px” border_color_all_button=”#2A4175″ locked=”off” global_colors_info=”{}” button_background_bgcolor__hover_enabled=”on|hover” button_background_bgcolor__hover=”#FFFFFF” button_text_color__hover_enabled=”on|desktop” button_text_color__hover=”#2A4175″][\/df_gravity_form][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
\u00centreb\u0103ri frecvente privind determinarea num\u0103rului de culoare EP:<\/h3>\n
[\/et_pb_text][difl_faq faq_layout=”plain” enable_schema=”on” admin_label=”FAQ” _builder_version=”4.27.5″ _module_preset=”default” locked=”off” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”][difl_faqitem question=”Care este num\u0103rul culorii EP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Num\u0103rul de culoare EP este o scal\u0103 de culoare definit\u0103 \u00een Farmacopeea European\u0103 (Ph. Eur.) pentru evaluarea lichidelor, \u00een special \u00een industria farmaceutic\u0103 \u0219i chimic\u0103. Ini\u021bial, aceasta s-a bazat pe o compara\u021bie vizual\u0103 cu solu\u021bii de referin\u021b\u0103 standardizate \u0219i este utilizat\u0103 pentru clasificarea calitativ\u0103 a intensit\u0103\u021bilor de culoare \u00een intervalul galben-maroniu. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”De ce este problematic\u0103 determinarea vizual\u0103 a num\u0103rului culorii PE?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Evaluarea vizual\u0103 depinde de factori individuali, cum ar fi percep\u021bia culorilor, oboseala, iluminatul \u0219i influen\u021bele mediului. Acest lucru poate duce la abateri \u00eentre inspectori sau loca\u021bii. Pentru mediile reglementate cu cerin\u021be ridicate privind reproductibilitatea \u0219i documenta\u021bia, aceast\u0103 subiectivitate este critic\u0103. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Cum poate fi determinat instrumental num\u0103rul de culori EP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Un spectrofotometru este utilizat pentru a m\u0103sura comportamentul de transmisie sau reflexie al probei \u00een domeniul spectral vizibil. Datele spectrale \u00eenregistrate sunt convertite \u00een valori CIE Lab* \u0219i comparate cu valorile de referin\u021b\u0103 EP stocate digital. Acest lucru asigur\u0103 o clasificare obiectiv\u0103 \u0219i reproductibil\u0103. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Ce iluminator ar trebui utilizat pentru m\u0103surarea culorilor EP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Iluminantul utilizat trebuie s\u0103 fie definit \u0219i constant. Se utilizeaz\u0103 adesea CIE D65 (simularea luminii naturale) sau CIE A (lumin\u0103 incandescent\u0103). Este esen\u021bial ca iluminantul, observatorul (2\u00b0 sau 10\u00b0) \u0219i geometria de m\u0103surare s\u0103 fie clar definite \u00een specifica\u021bii. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Ce rol joac\u0103 lungimea cuvei \u00een num\u0103rul de culori EP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Lungimea drumului optic influen\u021beaz\u0103 \u00een mod direct intensitatea culorii m\u0103surate (legea lui Lambert-Beer). Lungimile tipice ale cuvetelor sunt de 10 mm, 50 mm sau 100 mm. Pentru rezultate reproductibile, lungimea drumului trebuie standardizat\u0103 \u0219i documentat\u0103. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Determinarea instrumental\u0103 a num\u0103rului de culoare EP este conform\u0103 cu GMP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Da, cu condi\u021bia ca spectrofotometrul utilizat s\u0103 aib\u0103 func\u021bii adecvate, de ex:<\/p>\n
\n- Calibrare cu standarde trasabile<\/li>\n
- Administrarea utilizatorilor<\/li>\n
- Pista de audit<\/li>\n
- Copie de rezerv\u0103 electronic\u0103 a datelor<\/li>\n<\/ul>\n
Acest lucru \u00eenseamn\u0103 c\u0103 m\u0103surarea poate fi complet integrat\u0103 \u00eentr-un sistem de calitate conform GMP \u0219i 21 CFR partea 11.<\/p>\n
[\/difl_faqitem][difl_faqitem question=”Poate m\u0103surarea instrumental\u0103 s\u0103 \u00eenlocuiasc\u0103 complet metoda vizual\u0103?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
\u00cen multe aplica\u021bii, da. Metoda instrumental\u0103 reduce semnificativ influen\u021bele subiective \u0219i cre\u0219te comparabilitatea \u00eentre loca\u021bii. \u00cen mediile reglementate, aceasta este utilizat\u0103 din ce \u00een ce mai mult ca metod\u0103 preferat\u0103 sau cel pu\u021bin ca supliment la testul vizual. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Care sunt avantajele determin\u0103rii instrumentale a num\u0103rului de culori EP?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
\n- Reproductibilitate mai mare<\/li>\n
- Baza obiectiv\u0103 pentru luarea deciziilor<\/li>\n
- Eliberarea mai rapid\u0103 a loturilor<\/li>\n
- Mai pu\u021bine reclama\u021bii<\/li>\n
- Comparabilitate global\u0103<\/li>\n
- Documenta\u021bie complet\u0103 pentru audituri<\/li>\n
- Conformitatea cu standardele<\/li>\n<\/ul>\n
[\/difl_faqitem][difl_faqitem question=”Cum se determin\u0103 num\u0103rul de culoare EP pentru probe tulburi sau fluorescente?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Probele \u00eennorate pot cauza dispersia luminii, substan\u021bele fluorescente reac\u021bioneaz\u0103 sensibil la componentele UV ale sursei de lumin\u0103. \u00cen astfel de cazuri, este necesar\u0103 o defini\u021bie precis\u0103 a parametrilor de m\u0103surare – inclusiv o component\u0103 UV controlat\u0103. Dac\u0103 este necesar, speciale <\/span>Moduri de m\u0103surare<\/span><\/span>,<\/span><\/span><\/span> sau personalizat\u0103 <\/span><\/span>preg\u0103tirea probelor (de exemplu, filtrare) <\/span><\/span><\/span>aplicate<\/span><\/span><\/span>pot fi aplicate.<\/span><\/span> <\/span><\/p>\n[\/difl_faqitem][difl_faqitem question=”De ce este num\u0103rul de culori EP un parametru de calitate important?” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}” que_wrapper_bg_bgcolor__hover=”1px||||false|false” que_wrapper_bg_bgcolor__hover_enabled=”on|hover”]<\/p>\n
Abaterile de culoare pot indica oxidare, impurit\u0103\u021bi, procese de \u00eemb\u0103tr\u00e2nire sau abateri de la proces. Prin urmare, num\u0103rul de culoare EP nu este utilizat doar pentru clasificarea vizual\u0103, ci este \u0219i un indicator sensibil al calit\u0103\u021bii produsului \u0219i al stabilit\u0103\u021bii procesului. <\/p>\n
[\/difl_faqitem][\/difl_faq][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
\u00cen produc\u021bia \u0219i dezvoltarea de produse biofarmaceutice, sunt necesare solu\u021bii fiabile pentru determinarea num\u0103rului de culoare EP \u00een conformitate cu Ph. Eur. 2.2.2. Cu ajutorul solu\u021biilor tehnice speciale de la HunterLab, culoarea probelor lichide (chiar \u0219i \u00een cantit\u0103\u021bi foarte mici) poate fi examinat\u0103 cu cea mai mare precizie.
\nM\u0103surarea culorilor EP-Farbzahl-Ph-Eur-222
\nPentru a verifica calitatea produselor din probe lichide g\u0103lbui, aproape incolore, au fost dezvoltate special 37 de solu\u021bii comparative ale num\u0103rului de culoare EP. Acestea sunt utilizate pentru a determina calitatea culorilor produselor farmaceutice lichide, a proteinelor lichide concentrate sau a oric\u0103rui lichid care tinde s\u0103 devin\u0103 galben din cauza materiilor prime sau \u00een timpul procesului. Valoarea lor este, prin urmare, un indicator al \u00eemb\u0103tr\u00e2nirii sau al eficacit\u0103\u021bii substan\u021belor medicamentoase. <\/p>\n","protected":false},"author":2,"featured_media":406145,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"![\"\"](\"https:\/\/layouts.diviflash.xyz\/logistics\/wp-content\/uploads\/sites\/29\/2022\/12\/plane-trucks-are-flying-towards-destination-with-brightest-3d-rendering-illustration-1-scaled-1.jpg\")
\r\n\r\nOur airfreight staff attaches great importance to customizing the booking process for our customers. That\u2019s why we strive to find the air freight solution that best suits your needs. We\u2019ll ask you when the freight is available, best suits your needs. We\u2019ll ask you when the freight is available, what the required delivery date is, and best suits your needs. We\u2019ll ask you when the freight is available,\r\n\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.\r\n\r\n\u00a0\r\n
\u201cAnd the day came when the risk to remain tight in a bud was more painful than the risk it took to blossom.\u201d\r\n\r\nTomas Reuss<\/cite><\/blockquote>\r\n<\/h2>\r\nContext switch to boost productivity<\/h2>\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.\r\n\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.\r\n\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.![\"\"](\"https:\/\/layouts.diviflash.xyz\/logistics\/wp-content\/uploads\/sites\/29\/2022\/12\/theme_image_08-300x200.jpg\")
\u00a0bottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.\r\n\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, electric representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising a to 3 million and representing 4.1% of total car sales. of global car sales. In 2020, the overall a market contracted but electric car sales bucked the trend, rising to 3 million and representing electric bottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of in global car sales. In 2020, the overall car market contracted but electric car sales bucked the a trend, rising to 3 million and representing 4.1% of total car sales.\r\n\r\n\u00a0\r\n\r\n\r\n![\"\"](\"https:\/\/layouts.diviflash.xyz\/logistics\/wp-content\/uploads\/sites\/29\/2022\/12\/interior-large-distribution-warehouse-with-shelves-stacked-with-palettes-goods-ready-market.jpg\")
bottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales.\r\n\r\nbottlenecks. In 2019, 2.2 million electric cars 1 were sold, representing just 2.5% of global car sales. In 2020, the overall car market contracted but electric car sales bucked the trend, rising million and representing 4.1% of total car sales. bottlenecks. In 2019, 2.2 million electric cars were sold, representing just 2.5% of global car sales. In 2020, the overall car market contract electric car sales bucked the trend, rising to 3 million.","_et_gb_content_width":"","footnotes":""},"categories":[1564],"tags":[2294,2293,1565,2292],"class_list":["post-367990","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-colorimetrie-ro","tag-21-cfr-partea-11","tag-conformitate","tag-masurarea-culorii","tag-numarul-culorii-ep"],"_links":{"self":[{"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/posts\/367990","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/comments?post=367990"}],"version-history":[{"count":0,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/posts\/367990\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/media\/406145"}],"wp:attachment":[{"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/media?parent=367990"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/categories?post=367990"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/ro\/wp-json\/wp\/v2\/tags?post=367990"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
![\"HunterLab\"](\"https:\/\/hunterlab.de\/wp-content\/uploads\/2021\/04\/HunterLab-Zubehoer-Kuevetten-Vista-Spektralphotometer-1920w.png\")
![\"M\u0103surarea](\"https:\/\/www.hunterlab.eu\/wp-content\/uploads\/2024\/04\/Vista-APHA-EP-Farbzahl-Farbmessung-an-Kleinstmengen-Pharma-1920w.jpg\")
Cu toate acestea, procesul poate fi \u00eenlocuit foarte u\u0219or cu o tehnic\u0103 de m\u0103surare care utilizeaz\u0103