+49 8841 9464

sales@hunterlab.nl

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EP-kleurnummerbepaling en conforme kleurmeting

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Bepaling van kleurnummers en kleurmeting volgens GMP en FDA

Bij de productie en ontwikkeling van biofarmaceutische producten zijn betrouwbare oplossingen voor het bepalen van de EP Kleurnummer volgens Ph. Eur. 2.2.2 geïnstrueerd. Met speciale technische oplossingen van HunterLab wordt de kleur van vloeistofmonsters (zelfs in zeer kleine hoeveelheden) met de grootste nauwkeurigheid onderzocht.

HunterLab-Accessoires-Cuvette-Vista-Spectrofotometer
Om de productkwaliteit van gelige, bijna kleurloze vloeistofmonsters te controleren, zijn er speciaal 37 vergelijkende oplossingen van het EP-kleurengetal ontwikkeld. Deze worden gebruikt om de kleurkwaliteit te bepalen van vloeibare farmaceutische producten, geconcentreerde vloeibare proteïnen of elke vloeistof die de neiging heeft om geel te worden door de grondstoffen of tijdens het proces. Hun waarde is daarom een indicator voor de veroudering of effectiviteit van medicinale stoffen.

In veel bedrijven wordt nog steeds een visuele vergelijking met de EP-kleurstandaarden gebruikt om de kleur van vloeibare farmaceutische oplossingen te karakteriseren. Deze visuele methode is echter zeer subjectief, hangt af van de medewerker die de kleurvergelijking uitvoert en is moeilijk te valideren en te documenteren.

Het proces kan echter heel eenvoudig worden vervangen door een meettechniek met het Vista kleurmeetapparaat. De apparaten van HunterLab kunnen kleur meten en weergeven in de driedimensionale L*, a*, b* kleurruimte. Doelkleurwaarden en kleurstandaarden die voldoen aan de strenge eisen van de Europese Farmacopee zijn rechtstreeks in de software geïntegreerd.

Kleurmeting volgens 21 CFR Part 11 is ook mogelijk met HunterLab kleurmeetapparatuur. Dit betekent dat aan de eisen van de FDA kan worden voldaan door middel van elektronische records (logboeken) en handtekeningen.

In onze nieuwste uitgave HunterLab NEWS lees je meer over kleurmeting bij zeer kleine hoeveelheden, EP-kleurnummer en validatie & compliance of alles over kleurmeting in overeenstemming met FDA 21 CFR Part 11 in onze nieuwe whitepaper!

Whitepaper-kleurmeting-door-21-CFR-Part-11

Whitepaper: “FDA-conforme kleurmeting” & artikel: “Kleurmeting van zeer kleine hoeveelheden”.

Lees alles over validatie & compliance bij kleurmetingen in onze nieuwste whitepaper en in het HunterLab NEWS magazine hoe u betrouwbaar zeer kleine, vloeibare monsterhoeveelheden kunt meten en waar u op moet letten wat betreft monsterbehandeling.

Vul de twee onderstaande velden in en we sturen je het leesmateriaal als PDF!

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Contactgegevens HunterLab Europe GmbH

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Dr. August Einsele Ring 15,

82418 Murnau aan de Staffelsee

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[difl_advanced_blurb title="Contactgegevens" button_text="Neem contact met ons op" button_url="@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjM4NTAifX0=@" blurb_icon_enable="on" blurb_icon="||fa||900" blurb_icon_color="#2A4175" icon_size="40px" wrapper_padding="32px|32px|32px|32px|true|true" title_margin="14px||||false|false" button_margin="16px||||false|false" _builder_version="4.27.4" _dynamic_attributes="button_url" _module_preset="default" title_font="|700|||||||" title_text_color="#222222" title_font_size="18px" title_line_height="28px" content_body_font="||||||||" content_body_text_color="#7a7a7a" content_body_line_height="24px" button_text_font="|700|||||||" button_text_text_color="#222222" button_text_font_size="16px" button_text_line_height="26px" custom_padding="||0px||false|false" hover_enabled="0" border_radii="on|8px|8px|8px|8px" border_radii_content_border="on|8px|8px|8px|8px" global_colors_info="{}" blurb_icon_color__hover_enabled="on|hover" blurb_icon_color__hover="#FFFFFF" title_text_color__hover_enabled="on|hover" title_text_color__hover="#FFFFFF" content_body_text_color__hover_enabled="on|hover" content_body_text_color__hover="rgba(255,255,255,0.8)" button_text_text_color__hover_enabled="on|desktop" button_text_text_color__hover="#FFFFFF" background__hover_enabled="on|hover" background_color__hover="#2A4175" background_enable_color__hover="on" sticky_enabled="0"]E-mail: sales@hunterlab.de
Tel: +49 8841 9464[/difl_advanced_blurb]
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HunterLab Service & ondersteuning - klantgericht, snel, uniek.

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