[\/et_pb_text][et_pb_text _builder_version=”4.24.3″ header_3_font=”|700|||||||” background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”]<\/p>\n
In many companies, visual comparison with the EP colour<\/a> standards<\/a> is still used to characterize the colour<\/a> of liquid drug solutions. However, this visual method is very subjective, depends on the employee carrying out the comparison and is difficult to validate and document<\/strong>.<\/p>\n However, the process can be very easily replaced by a measurement technique using the Vista color measurement device<\/a>. HunterLab devices can measure and display color in the three-dimensional L*, a*, b* color space. Target color values and color standards<\/a> that meet the strict requirements of the European Pharmacopoeia are integrated directly into the software<\/strong>.<\/p>\n Color measurement in accordance with 21 CFR Part 11<\/strong> is also possible with HunterLab color measurement devices. This means that the requirements of the FDA<\/a> can be complied with by means of electronic records (logs) and signatures. <\/p>\n Read more about color measurement of very small quantities, EP color number and validation & compliance<\/strong> in our current HunterLab NEWS issue or everything about FDA-compliant<\/strong> color measurement according to 21 CFR Part 11<\/strong> in our new whitepaper!<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Color measurement in accordance with 21 CFR Part 11<\/strong> is also possible with HunterLab color measurement devices. This means that the requirements of the FDA<\/a> can be complied with by means of electronic records (logs) and signatures. <\/p>\n Read more about color measurement of very small quantities, EP color number and validation & compliance<\/strong> in our current HunterLab NEWS issue or everything about FDA-compliant<\/strong> color measurement according to 21 CFR Part 11<\/strong> in our new whitepaper!<\/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” hover_enabled=”0″ locked=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Read all about validation & compliance in color measurement in our latest white paper and how to reliably measure very small, liquid sample quantities and what to look out for in terms of sample handling in our HunterLab NEWS magazine.<\/p>\n Please fill in the two fields below and you can immediately read the PDFs!<\/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” hover_enabled=”0″ 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″ sticky_enabled=”0″][\/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 [\/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=”What is the EP color number?” _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 The EP color number is a colour<\/a> scale defined in the European Pharmacopoeia (Ph. Eur.) for the assessment of liquids, especially in the pharmaceutical and chemical industries. It is originally based on a visual comparison with standardized reference solutions and is used for the qualitative classification of colour<\/a> intensities in the yellowish-brown range. <\/p>\n [\/difl_faqitem][difl_faqitem question=”Why is the visual determination of the EP color number problematic?” _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 The visual assessment depends on individual factors such as color perception, fatigue, lighting and environmental influences. This can lead to deviations between inspectors or locations. For regulated environments with high demands on reproducibility and documentation, this subjectivity is critical. <\/p>\n [\/difl_faqitem][difl_faqitem question=”How can the EP color number be determined instrumentally?” _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 A spectrophotometer<\/a> is used to measure the transmission<\/a> or reflection<\/a> behavior of the sample in the visible spectral range. The recorded spectral data is converted into CIE Lab* values and compared with digitally stored EP reference values. This ensures that the classification is objective and reproducible. <\/p>\n [\/difl_faqitem][difl_faqitem question=”Which illuminant should be used for EP color measurement?” _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 The illuminant used must be defined and constant. CIE D65 (daylight simulation) or CIE A (incandescent light<\/a>) are often used. It is crucial that the illuminant, observer (2° or 10°) and measurement geometry<\/a> are clearly defined in the specification. <\/p>\n [\/difl_faqitem][difl_faqitem question=”What role does the cuvette length play in the EP color number?” _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 The optical path length directly influences the measured color intensity (Lambert-Beer’s law). Typical cuvette lengths are 10 mm, 50 mm or 100 mm. For reproducible results, the path length must be standardized and documented. <\/p>\n [\/difl_faqitem][difl_faqitem question=”Is the instrumental determination of the EP color number GMP-compliant?” _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 Yes, provided the spectrophotometer<\/a> used has suitable functions, e.g:<\/p>\n This means that the measurement can be fully integrated into a GMP and 21 CFR Part 11-compliant quality system.<\/p>\n [\/difl_faqitem][difl_faqitem question=”Can instrumental measurement completely replace the visual method?” _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 In many applications, yes. The instrumental method significantly reduces subjective influences and increases comparability between locations. In regulated environments, it is increasingly being used as the preferred method or at least as a supplement to the visual test. <\/p>\n [\/difl_faqitem][difl_faqitem question=”What are the advantages of instrumental EP shade determination?” _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 [\/difl_faqitem][difl_faqitem question=”How is the EP color number determined for turbid or fluorescent samples?” _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 Cloudy samples can cause scattered light<\/a>, fluorescent substances react sensitively to UV components of the light<\/a> source. In such cases, a precise definition of the measurement parameters – including a controlled UV component – is required. If necessary, special <\/span>Measuring modes<\/span><\/span>,<\/span><\/span><\/span> or adapted <\/span><\/span>sample preparations (e.g. filtration) <\/span><\/span><\/span>applied<\/span><\/span><\/span>can be applied.<\/span><\/span> <\/span><\/p>\n [\/difl_faqitem][difl_faqitem question=”Why is the EP color number an important quality parameter?” _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 Color deviations can indicate oxidation, impurities, aging processes or process deviations. The EP color number is therefore not only used for visual classification, but is also a sensitive indicator of product quality and process stability. <\/p>\n [\/difl_faqitem][\/difl_faq][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" In the production and development of biopharmaceutical products, reliable solutions for determining the EP color number according to Ph. Eur. 2.2.2 Instructed. Special technical solutions from HunterLab are used to examine the color of liquid samples (even in very small quantities) with the greatest accuracy.![\"HunterLab-Accessories-Cuvette-Vista-Spectrophotometer\"](\"https:\/\/hunterlab.de\/wp-content\/uploads\/2021\/04\/HunterLab-Zubehoer-Kuevetten-Vista-Spektralphotometer-1920w.png\")
In order to check the product quality of yellowish, almost colorless liquid samples, 37 comparative solutions of the EP color number<\/strong> were specially developed. These are used to determine the color quality of liquid pharmaceutical products<\/strong>, concentrated liquid proteins<\/strong> or any liquid that tends to turn yellow<\/strong> due to its starting materials or during the process<\/strong>. Their value is therefore an indicator of the ageing or effectiveness of medicinal substances. <\/p>\n![\"Color](\"https:\/\/www.hunterlab.eu\/wp-content\/uploads\/2024\/04\/Vista-APHA-EP-Farbzahl-Farbmessung-an-Kleinstmengen-Pharma-1920w.jpg\")
However, the process can be very easily replaced by a measurement technique using the Vista color measurement device<\/a>. HunterLab devices can measure and display color in the three-dimensional L*, a*, b* color space. Target color values and color standards<\/a> that meet the strict requirements of the European Pharmacopoeia are integrated directly into the software<\/strong>.<\/p>\n![\"Whitepaper-color-measurement-by-21-CFR-Part-11\"](\"https:\/\/hunterlab.de\/wp-content\/uploads\/2024\/04\/Whitepaper-Farbmessung-nach-21-CFR-Part-11-w-1920w-243x300.png\")
<\/p>\nWhitepaper: “Color Measurement FDA-compliant”:<\/h3>\n
Frequently asked questions about EP color number determination:<\/h3>\n
\n
\n
\nColor measurement-EP color number-Ph-Eur-222
\nTo check the product quality of yellowish, almost colorless liquid samples, 37 comparative solutions of the EP color number have been specially developed. These are used to determine the color quality of liquid pharmaceutical products, concentrated liquid proteins or any liquid that tends to turn yellow due to its starting materials or during the process. Its value is therefore an indicator of the ageing or effectiveness of medicinal substances. <\/p>\n","protected":false},"author":2,"featured_media":287132,"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\n
Context 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":[806],"tags":[2297,874,2296,2295],"class_list":["post-342015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-colorimetry","tag-21-cfr-part-11","tag-colour-measurement","tag-compliance","tag-ep-color-number"],"_links":{"self":[{"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/posts\/342015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/comments?post=342015"}],"version-history":[{"count":0,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/posts\/342015\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/media\/287132"}],"wp:attachment":[{"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/media?parent=342015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/categories?post=342015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hunterlab.eu\/en\/wp-json\/wp\/v2\/tags?post=342015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}