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[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”About” _builder_version=”4.20.2″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png” background_size=”initial” background_position=”top_right” custom_padding=”||||false|false” custom_padding_tablet=”||||false|false” custom_padding_phone=”” hover_enabled=”0″ locked=”off” global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.20.2″ custom_margin_tablet=”” custom_margin_phone=”” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”||0px||false|false” hover_enabled=”0″ global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″][et_pb_column type=”1_2″ _builder_version=”4.17.3″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/05\/19-IMP-0619-ASSET-LOCKER-1-53-1-scaled.jpg” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_divider color=”#a6d5f3″ divider_weight=”8px” _builder_version=”4.16″ max_width=”40px” module_alignment=”left” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_divider][et_pb_text _builder_version=”4.18.0″ text_font=”||||||||” text_font_size=”16px” text_line_height=”2em” header_font=”Rubik|500|||||||” header_text_color=”#1a3066″ header_font_size=”54px” header_line_height=”1.3em” header_2_font=”|700|||||||” header_2_text_color=”#1E1E1E” header_2_font_size=”38px” header_2_line_height=”1.3em” text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”44px” header_font_size_phone=”34px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”]<\/p>\n
The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber),\u00a0rather than\u00a0metal or glass. Polymers offer more versatility, since they are light-weight, flexible and much more durable than their traditional counterparts. Additives can be incorporated into polymers to give them clarity that rivals that of glass,\u00a0or\u00a0to add color to the materials,\u00a0or that can give the polymer a desired physical property.\u00a0However, given all of the positive attributes that polymers possess, there are also some negatives to consider when working with them in medical applications. In the presence of heat, light, oxygen, and various external influences, such as sterilization, polymers can degrade over time if not properly stabilized. This degradation can manifest itself as cracking, discoloration, or surface blooming\/exudation and can severely impact the mechanical properties of the polymers. Stabilizers,\u00a0and other\u00a0additives, are\u00a0often\u00a0incorporated into\u00a0polymers to prevent this degradation. Yet this results in a more complex formulation than typical metal and glass and makes materials such as plastic and rubber much more prone to leaching unwanted chemicals into the drug product formulation when they are used in applications such as manufacturing, drug delivery devices, or packaging. The experts at Impact Analytical have the experience and resources to perform Extractables and Leachables studies that mitigate the risk associated with using these materials and ensure a safe and compliant product.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”About” _builder_version=”4.16″ background_color=”#e8e8e8″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2021\/10\/molecules-bg.png” background_size=”initial” background_position=”top_right” custom_padding=”35px||35px||true|false” custom_padding_tablet=”||||false|false” custom_padding_phone=”” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.17.3″ custom_margin=”||||false|false” custom_padding_tablet=”” custom_padding_phone=”||0px||false|false” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_column type=”1_2″ _builder_version=”4.16″ global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_divider color=”#a6d5f3″ divider_weight=”8px” _builder_version=”4.16″ max_width=”40px” module_alignment=”left” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_divider][et_pb_text _builder_version=”4.20.2″ text_font=”||||||||” text_font_size=”16px” text_line_height=”2em” header_font=”Rubik|500|||||||” header_text_color=”#1a3066″ header_font_size=”54px” header_line_height=”1.3em” header_2_font=”|700|||||||” header_2_text_color=”#1E1E1E” header_2_font_size=”38px” header_2_line_height=”1.3em” custom_margin=”-25px|||||” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”44px” header_font_size_phone=”34px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″]<\/p>\n
Our extensive plastics characterization experience is the backbone of our Extractables & Leachables testing regiment. This knowledge serves as a solid foundation for our experts to quickly and efficiently characterize container closure systems for leachables. We follow Product Quality Research Institute (PQRI) best practices to ensure all studies are thorough and compliant. While a proven testing process is the starting point, each project benefits from our scientific experience and ability to customize methods and develop the best testing solutions.<\/p>\n
Extractables & Leachables Process<\/strong><\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.17.3″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/05\/21-IMP-1207-IMPACT-WEBSITE-SHOOT-65-scaled.jpg” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_divider show_divider=”off” _builder_version=”4.17.3″ _module_preset=”default” custom_padding=”150px||150px||true|false” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Why Us” _builder_version=”4.16″ background_color=”#009dd5″ custom_padding=”||34px|||” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.17.3″ global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_column type=”1_2″ _builder_version=”4.17.3″ background_image=”https:\/\/www.impactanalytical.com\/wp-content\/uploads\/2022\/05\/19-IMP-0619-ASSET-LOCKER-1-50-scaled.jpg” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_divider color=”#FFFFFF” divider_weight=”8px” _builder_version=”4.16″ max_width=”40px” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_divider][et_pb_text _builder_version=”4.20.2″ text_font=”||||||||” text_text_color=”#FFFFFF” text_font_size=”16px” text_line_height=”2em” header_font=”Rubik|500|||||||” header_text_color=”#1a3066″ header_font_size=”54px” header_line_height=”1.3em” header_2_font=”|600|||||||” header_2_text_color=”#FFFFFF” header_2_font_size=”38px” header_2_line_height=”1.3em” custom_margin=”-16px|||||” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”44px” header_font_size_phone=”34px” header_font_size_last_edited=”on|phone” header_2_font_size_tablet=”30px” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″]<\/p>\n Impact Analytical is a cGMP compliant laboratory that has been recently audited by the FDA, with no 483\u2019s issued. All study design and E&L testing is performed according to the latest industry recognized \u201cbest practices\u201d including the United States Pharmacopeia (USP), Product Quality Research Institute (PQRI), Bio-Process Systems Alliance (BPSA), and ISO-10993.<\/strong><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_row _builder_version=”4.17.3″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_column type=”4_4″ _builder_version=”4.17.3″ _module_preset=”default” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_cta title=”Related Whitepapers” button_text=”Click Here” _builder_version=”4.20.2″ _module_preset=”default” background_color=”#696B73″ hover_enabled=”0″ global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″]<\/p>\n\n
\u2013 Initial materials assessment
\u2013 Primary contacting components
\u2013 Secondary contacting components
\u2013 Associated closure and packaging systems
> Associated components<\/li>\n
\u2013 Material extraction
\u2013 Analysis of the extracts
> Multiple separation and detection techniques to identify volatiles, semi-volatiles, non-volatiles\u00a0and inorganics
> Establishment of leachables threshold limits<\/li>\n
\u2013 Leachables testing
\u2013 Correlation establishment
\u2013 Evaluation of leachable profile
> Toxicology evaluation<\/li>\n
<\/strong> \u2013 Release testing
\u2013 Lot Testing<\/li>\n<\/ol>\n