FDA 21 CFR Part 11 -vaatimusten mukaisesti<\/strong>!<\/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
![\"v\u00e4rinmittaus\"](\"https:\/\/hunterlab.de\/wp-content\/uploads\/2024\/04\/Whitepaper-Farbmessung-nach-21-CFR-Part-11-w-1920w-243x300.png\")
<\/p>\n
Whitepaper: “FDA-yhteensopiva v\u00e4rinmittaus”:<\/h3>\n
Lue kaikki validoinnista ja vaatimustenmukaisuudesta v\u00e4rinmittauksissa uusimmasta valkoisesta kirjastamme ja HunterLab NEWS -lehdest\u00e4, miten mitata luotettavasti hyvin pieni\u00e4 nestem\u00e4isi\u00e4 n\u00e4ytem\u00e4\u00e4ri\u00e4 ja mit\u00e4 n\u00e4ytteiden k\u00e4sittelyss\u00e4 on huomioitava.<\/p>\n
T\u00e4yt\u00e4 alla olevat kaksi kentt\u00e4\u00e4, niin l\u00e4het\u00e4mme sinulle lukumateriaalin PDF-muodossa!<\/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
Usein kysyttyj\u00e4 kysymyksi\u00e4 EP-v\u00e4rinumeron m\u00e4\u00e4ritt\u00e4misest\u00e4:<\/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=”Mik\u00e4 on EP-v\u00e4rin numero?” _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
EP-v\u00e4riluku on Euroopan farmakopeassa (Ph. Eur.) m\u00e4\u00e4ritelty v\u00e4riasteikko nesteiden arviointia varten erityisesti l\u00e4\u00e4keteollisuudessa ja kemianteollisuudessa. Se perustuu alun perin visuaaliseen vertailuun standardoitujen vertailuliuosten kanssa, ja sit\u00e4 k\u00e4ytet\u00e4\u00e4n v\u00e4rin voimakkuuden kvalitatiiviseen luokitteluun kellert\u00e4v\u00e4n ruskean alueella. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Miksi EP:n v\u00e4riluvun visuaalinen m\u00e4\u00e4ritt\u00e4minen on ongelmallista?” _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\u00e4\u00f6n arviointi riippuu yksil\u00f6llisist\u00e4 tekij\u00f6ist\u00e4, kuten v\u00e4rin havaitsemisesta, v\u00e4symyksest\u00e4, valaistuksesta ja ymp\u00e4rist\u00f6n vaikutuksista. T\u00e4m\u00e4 voi johtaa poikkeamiin tarkastajien tai paikkojen v\u00e4lill\u00e4. S\u00e4\u00e4nnellyiss\u00e4 ymp\u00e4rist\u00f6iss\u00e4, joissa toistettavuudelle ja dokumentoinnille asetetaan korkeat vaatimukset, t\u00e4m\u00e4 subjektiivisuus on kriittinen tekij\u00e4. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Miten EP:n v\u00e4riluku voidaan m\u00e4\u00e4ritt\u00e4\u00e4 instrumentaalisesti?” _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
Spektrofotometri\u00e4 k\u00e4ytet\u00e4\u00e4n mittaamaan n\u00e4ytteen l\u00e4p\u00e4isy- tai heijastusk\u00e4ytt\u00e4ytymist\u00e4 n\u00e4kyv\u00e4n spektrin alueella. Tallennetut spektritiedot muunnetaan CIE Lab* -arvoiksi ja niit\u00e4 verrataan digitaalisesti tallennettuihin EP-vertailuarvoihin. N\u00e4in varmistetaan objektiivinen ja toistettavissa oleva luokittelu. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Mit\u00e4 valaisinta olisi k\u00e4ytett\u00e4v\u00e4 v\u00e4rinmittauksessa?” _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
K\u00e4ytett\u00e4v\u00e4n valonl\u00e4hteen on oltava m\u00e4\u00e4ritelty ja vakio. Usein k\u00e4ytet\u00e4\u00e4n CIE D65 (p\u00e4iv\u00e4nvalosimulaatio) tai CIE A (hehkulamppu). On eritt\u00e4in t\u00e4rke\u00e4\u00e4, ett\u00e4 valovoima, havaitsija (2\u00b0 tai 10\u00b0) ja mittausgeometria m\u00e4\u00e4ritell\u00e4\u00e4n selv\u00e4sti eritelm\u00e4ss\u00e4. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Mik\u00e4 merkitys kyvettien pituudella on EP-v\u00e4rilukuun?” _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
Optisen reitin pituus vaikuttaa suoraan mitattuun v\u00e4rin voimakkuuteen (Lambert-Beerin laki). Tyypillisi\u00e4 kyvettien pituuksia ovat 10 mm, 50 mm tai 100 mm. Jotta tulokset olisivat toistettavissa, kulkureitin pituus on standardoitava ja dokumentoitava. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Onko EP-v\u00e4riluvun m\u00e4\u00e4ritt\u00e4minen instrumentein GMP:n mukainen?” _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
Kyll\u00e4, edellytt\u00e4en, ett\u00e4 k\u00e4ytett\u00e4v\u00e4ss\u00e4 spektrofotometriss\u00e4 on sopivat toiminnot, esim. seuraavat:<\/p>\n
\n- Kalibrointi j\u00e4ljitett\u00e4vien standardien avulla<\/li>\n
- K\u00e4ytt\u00e4jien hallinta<\/li>\n
- Tarkastusketju<\/li>\n
- S\u00e4hk\u00f6inen varmuuskopiointi<\/li>\n<\/ul>\n
T\u00e4m\u00e4 tarkoittaa, ett\u00e4 mittaus voidaan integroida t\u00e4ysin GMP- ja 21 CFR Part 11 -vaatimusten mukaiseen laatuj\u00e4rjestelm\u00e4\u00e4n.<\/p>\n
[\/difl_faqitem][difl_faqitem question=”Voiko instrumentaalinen mittaus korvata kokonaan visuaalisen menetelm\u00e4n?” _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
Monissa sovelluksissa kyll\u00e4. Instrumenttimenetelm\u00e4 v\u00e4hent\u00e4\u00e4 merkitt\u00e4v\u00e4sti subjektiivisia vaikutteita ja parantaa vertailukelpoisuutta eri paikkojen v\u00e4lill\u00e4. S\u00e4\u00e4nnellyiss\u00e4 ymp\u00e4rist\u00f6iss\u00e4 sit\u00e4 k\u00e4ytet\u00e4\u00e4n yh\u00e4 useammin ensisijaisena menetelm\u00e4n\u00e4 tai ainakin visuaalisen testin t\u00e4ydent\u00e4j\u00e4n\u00e4. <\/p>\n
[\/difl_faqitem][difl_faqitem question=”Mitk\u00e4 ovat EP-v\u00e4riluvun instrumentaalisen m\u00e4\u00e4rityksen edut?” _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- Parempi toistettavuus<\/li>\n
- Objektiivinen perusta p\u00e4\u00e4t\u00f6ksenteolle<\/li>\n
- Nopeampi erien vapauttaminen<\/li>\n
- V\u00e4hemm\u00e4n valituksia<\/li>\n
- Maailmanlaajuinen vertailukelpoisuus<\/li>\n
- T\u00e4ydellinen dokumentaatio tarkastuksia varten<\/li>\n
- Standardien mukaisuus<\/li>\n<\/ul>\n
[\/difl_faqitem][difl_faqitem question=”Miten EP-v\u00e4riluku m\u00e4\u00e4ritet\u00e4\u00e4n sameille tai fluoresoiville n\u00e4yteille?” _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
Pilviset n\u00e4ytteet voivat aiheuttaa hajavaloa, fluoresoivat aineet reagoivat herk\u00e4sti valonl\u00e4hteen UV-komponentteihin. T\u00e4llaisissa tapauksissa tarvitaan mittausparametrien tarkka m\u00e4\u00e4rittely – mukaan lukien valvottu UV-komponentti. Tarvittaessa erityiset <\/span>Mittaustilat<\/span><\/span>,<\/span><\/span><\/span> tai r\u00e4\u00e4t\u00e4l\u00f6ityj\u00e4 <\/span><\/span>n\u00e4ytteiden valmistelu (esim. suodatus) <\/span><\/span><\/span>sovellettu<\/span><\/span><\/span>voidaan soveltaa.<\/span><\/span> <\/span><\/p>\n[\/difl_faqitem][difl_faqitem question=”Miksi EP-v\u00e4rinumero on t\u00e4rke\u00e4 laatuparametri?” _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
V\u00e4ripoikkeamat voivat viitata hapettumiseen, ep\u00e4puhtauksiin, vanhenemisprosesseihin tai prosessipoikkeamiin. EP-v\u00e4rilukua ei siis k\u00e4ytet\u00e4 ainoastaan visuaaliseen luokitteluun, vaan se on my\u00f6s herkk\u00e4 tuotteen laadun ja prosessin vakauden indikaattori. <\/p>\n
[\/difl_faqitem][\/difl_faq][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
Biol\u00e4\u00e4kkeiden tuotannossa ja kehityksess\u00e4 tarvitaan luotettavia ratkaisuja EP-v\u00e4riluvun m\u00e4\u00e4ritt\u00e4miseksi Ph. Eur. 2.2.2. HunterLab:n teknisill\u00e4 erikoisratkaisuilla nestem\u00e4isten n\u00e4ytteiden v\u00e4ri (jopa hyvin pieniss\u00e4 m\u00e4\u00e4riss\u00e4) voidaan tutkia suurimmalla tarkkuudella.
\nV\u00e4rinmittaus-EP-Farbzahl-Ph-Eur-222
\nKeltaisten, l\u00e4hes v\u00e4ritt\u00f6mien nestem\u00e4isten n\u00e4ytteiden tuotelaadun tarkastamiseksi on kehitetty erityisesti 37 EP-v\u00e4riluvun vertailuliuosta. Niit\u00e4 k\u00e4ytet\u00e4\u00e4n nestem\u00e4isten l\u00e4\u00e4kevalmisteiden, v\u00e4kev\u00f6ityjen nestem\u00e4isten proteiinien tai mink\u00e4 tahansa nesteen v\u00e4rin laadun m\u00e4\u00e4ritt\u00e4miseen, jolla on taipumus kellastua l\u00e4ht\u00f6aineidensa vuoksi tai prosessin aikana. Niiden arvo on siis indikaattori l\u00e4\u00e4keaineiden vanhenemisesta tai tehokkuudesta. <\/p>\n","protected":false},"author":2,"featured_media":406143,"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":[1553],"tags":[2318,2316,2317,1561],"class_list":["post-368002","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kolorimetria","tag-21-cfr-11-osa","tag-ep-vaerin-numero","tag-vaatimustenmukaisuus","tag-vaerin-mittaus"],"_links":{"self":[{"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/posts\/368002","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/comments?post=368002"}],"version-history":[{"count":0,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/posts\/368002\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/media\/406143"}],"wp:attachment":[{"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/media?parent=368002"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/categories?post=368002"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/fi\/wp-json\/wp\/v2\/tags?post=368002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
![\"HunterLab\"](\"https:\/\/www.hunterlab.eu\/wp-content\/uploads\/2021\/04\/HunterLab-Zubehoer-Kuevetten-Vista-Spektralphotometer-1920w.png\")
![\"Kellert\u00e4v\u00e4n](\"https:\/\/www.hunterlab.eu\/wp-content\/uploads\/2024\/04\/Vista-APHA-EP-Farbzahl-Farbmessung-an-Kleinstmengen-Pharma-1920w.jpg\")
Prosessi voidaan kuitenkin hyvin helposti korvata mittaustekniikalla, jossa k\u00e4ytet\u00e4\u00e4n