MedAccred Certificate<\/strong><\/a>\u00a0\u2013 Sterile Device Packaging \u2013 Assembly and Closure\/Sealing of Packaging Systems.[\/vc_column_text][vc_row_inner column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][image_with_animation image_url=”191″ image_size=”full” animation_type=”entrance” animation=”Fade In” hover_animation=”none” alignment=”” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default”][\/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][image_with_animation image_url=”196″ image_size=”full” animation_type=”entrance” animation=”Fade In” hover_animation=”none” alignment=”” img_link_target=”_blank” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default” img_link=”https:\/\/www.cretexmedical.com\/qts\/certificate-sdp-letter-expiration-28feb2027\/”][\/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][image_with_animation image_url=”195″ image_size=”full” animation_type=”entrance” animation=”Fade In” hover_animation=”none” alignment=”” img_link_target=”_blank” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default” img_link=”https:\/\/www.cretexmedical.com\/qts\/q8-066914-0009-rev-02-quality-tech-services-llc-721015545-exp-2029-04-03\/”][\/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][\/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][\/vc_column_inner][vc_column_inner column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/6″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][\/vc_column_inner][\/vc_row_inner][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”default” custom_height=”100″][image_with_animation image_url=”76″ image_size=”full” animation_type=”entrance” animation=”Fade In” hover_animation=”none” alignment=”” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default”][vc_custom_heading text=”Compliant Standards” use_theme_fonts=”yes” el_id=”quality-compliant”][vc_column_text]FDA CFR 21 Part 820\u00a0\u2013\u00a0Quality System Regulation \u2013 Medical Devices<\/p>\nISO 13485\u00a0\u2013 Medical devices \u2013\u00a0Quality management systems \u2013\u00a0Requirements for regulatory purposes<\/p>\n
ISO 11607-1\u00a0\u2013\u00a0Packaging for terminally sterilized medical devices \u2013\u00a0Part 1: Requirements for materials, sterile barrier systems and packaging<\/p>\n
ISO 11607-2\u00a0\u2013\u00a0Packaging for terminally sterilized medical devices \u2013 Part 2: Validation requirements for forming, sealing and assembly processes<\/p>\n
ISO 14971\u00a0\u2013\u00a0Medical devices\u00a0\u2013\u00a0Application of risk management to medical devices<\/p>\n
ISO 14698\u00a0\u2013\u00a0Cleanrooms and associated controlled environments \u2013\u00a0Biocontamination control<\/p>\n
ISO 14644-1\u00a0\u2013\u00a0Cleanrooms and associated controlled environments, Certified ISO Class 7 Cleanrooms<\/p>\n
J-PMDA\u00a0\u2013\u00a0J-PMDA MHLW Ministerial Ordinance No. 169[\/vc_column_text][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”default” custom_height=”100″][image_with_animation image_url=”76″ image_size=”full” animation_type=”entrance” animation=”Fade In” hover_animation=”none” alignment=”” border_radius=”none” box_shadow=”none” image_loading=”default” max_width=”100%” max_width_mobile=”default”][vc_custom_heading text=”Licenses” use_theme_fonts=”yes” el_id=”quality-licenses”][vc_column_text]State of Minnesota Board of Pharmacy Manufacturers License[\/vc_column_text][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”default” custom_height=”100″][vc_custom_heading text=”Procedural Guidelines” use_theme_fonts=”yes” el_id=”procedural-guidelines”][toggles style=”default”][toggle color=”Default” heading_tag=”default” title=”Sterilization”][vc_column_text]AAMI ST72<\/strong>
\nBacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing<\/p>\nAAMI TIR16<\/strong>
\nProcess development and performance qualification for ethylene oxide sterilization \u2013 Microbiological aspects<\/p>\nAAMI TIR28<\/strong>
\nProduct adoption and process equivalence for ethylene oxide sterilization<\/p>\nAAMI TIR 33<\/strong>
\nSterilization of health care products \u2013 Radiation sterilization \u2013 Substantiation of a selected sterilization dose \u2013 Method VDmax<\/p>\nISO 10993-7<\/strong>
\nBiological evaluation of medical devices \u2013 Part 7: Ethylene oxide sterilization residuals<\/p>\nISO 11135-1<\/strong>
\nSterilization of health care products \u2013 Ethylene oxide \u2013 Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices<\/p>\nISO 11137-1<\/strong>
\nSterilization of health care products \u2013 Radiation \u2013 Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices<\/p>\nISO 11137-2<\/strong>
\nSterilization of health care products \u2013 Radiation \u2013 Part 2: Establishing the sterilization dose<\/p>\nISO 11137-3<\/strong>
\nSterilization of health care products \u2013 Radiation \u2013 Part 3: Guidance on dosimetric aspects<\/p>\nISO 11138-1<\/strong>
\nSterilization of health care products \u2013 Biological indicators \u2013 Part 1: General requirements<\/p>\nISO 11138-2<\/strong>
\nSterilization of health care products \u2013 Biological indicators \u2013 Part 2: Biological indicators for ethylene oxide sterilization processes<\/p>\nISO 11737-1<\/strong>
\nSterilization of medical devices \u2013 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/p>\nISO 11737-2<\/strong>
\nSterilization of medical devices \u2013 Microbiological methods \u2013 Part 2: Tests of sterility performed in the validation of a sterilization process<\/p>\nISO 17665-1<\/strong>
\nSterilization of health care products \u2013 Moist heat \u2013 Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices[\/vc_column_text][\/toggle][toggle color=”Default” heading_tag=”default” title=”Packaging”][vc_column_text]ASTM D3078<\/strong>
\nStandard Method for Determination of Leaks in Flexible Packaging by Bubble Emission<\/p>\nASTM D4169<\/strong>
\nStandard Practice for Performance Testing of Shipping Containers and Systems<\/p>\nASTM F88<\/strong>
\nStandard Test Method for Seal Strength of Flexible Barriers Materials<\/p>\nASTM F1140<\/strong>
\nStandard Test Method for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications<\/p>\nASTM F1608<\/strong>
\nStandard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)<\/p>\nASTM F1886<\/strong>
\nStandard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection<\/p>\nASTM F1929<\/strong>
\nStandard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration<\/p>\nASTM F1980<\/strong>
\nStandard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices<\/p>\nASTM F2096<\/strong>
\nStandard Test Method for Detecting Leaks in Medical Packaging by Internal Pressurization (Bubble Test)<\/p>\nDuPont Medical Packaging<\/strong>
\nTechnical Reference Guide<\/p>\nDuPont Tyvek\u00ae Compliance<\/strong>
\nCompliance to ISO 11607-1:2006, K-16972<\/p>\nISO 11607-1<\/strong>
\nPackaging for terminally sterilized medical devices \u2013 Part 1: Requirements for materials, sterile barrier systems and packaging<\/p>\nISO 11607-2<\/strong>
\nPackaging for terminally sterilized medical devices \u2013 Part 2: Validation requirements for forming, sealing and assembly processes<\/p>\nISTA 3A<\/strong>
\nPackaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less[\/vc_column_text][\/toggle][toggle color=”Default” heading_tag=”default” title=”Quality Systems”][vc_column_text]AAMI TIR36<\/strong>
\nValidation of software for regulated processes<\/p>\nANSI Z1.9 (ASQC)<\/strong>
\nSampling Procedures and Tables for Inspection by Variables for Percent Nonconforming<\/p>\nANSI Z1.4 (ASQC)<\/strong>
\nSampling Procedures and Tables for Inspection by Attributes<\/p>\nFDA 21 CFR 210 and 211<\/strong>
\ncGMP Practice in Manufacturing, Processing, Packing or Holding of Drugs; Practice for Finished Pharmaceuticals<\/p>\nFDA 21 CFR 820<\/strong>
\nQuality System Regulation (GMP for Medical Devices)<\/p>\nISO 13485<\/strong>
\nMedical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes<\/p>\nISO 14971<\/strong>
\nMedical devices \u2013 Application of risk management to medical devices<\/p>\nISO 9001<\/strong>
\nQuality management systems \u2013 Requirements<\/p>\nJ-PMDA<\/strong>
\nJ-PMDA MHLW Ministerial Ordinance No. 169<\/p>\nOSHA 29 CFR 1910<\/strong>
\nBlood borne Pathogens[\/vc_column_text][\/toggle][toggle color=”Default” heading_tag=”default” title=”Cleaning \/ Passivation”][vc_column_text]ASTM A380<\/strong>
\nStandard Practice for Cleaning, Descaling, and Passsivation of Stainless Steel Parts, Equipment, and Systems<\/p>\nASTM A967<\/strong>
\nStandard Specification for Chemical Passivation Treatments for Stainless Steel Parts<\/p>\nASTM B600<\/strong>
\nStandard Guide for Descaling and Cleaning Titanium Alloy Surfaces<\/p>\nASTM F2459<\/strong>
\nStandard Test Method for Extracting Residue from Metallic Medical components and Quantifying via Gravimetric analysis<\/p>\nISO 10993-5<\/strong>
\nBiological evaluation of medical devices \u2013 Part 5: Tests for in vitro cytotoxicity[\/vc_column_text][\/toggle][toggle color=”Default” heading_tag=”default” title=”Labeling”][vc_column_text]FDA 21 CFR Part 801<\/strong>
\nMedical Devices: Labeling, including Unique Device Identification (UDI)<\/p>\nISO 15223-1 (formerly EN980)<\/strong>
\nMedical devices \u2013 Symbols to be used with medical device labels, labeling, and information to be supplied \u2013 Part 1: General requirements<\/p>\nGS1 and HIBCC<\/strong>
\nUDI Compliant Barcoding[\/vc_column_text][\/toggle][toggle color=”Default” heading_tag=”default” title=”Environmental”][vc_column_text]ISO 14644-1<\/strong>
\nCleanrooms and associated controlled environments \u2013 Part 1: Classification of air cleanliness<\/p>\nISO 14644-2<\/strong>
\nCleanrooms and associated controlled environments \u2013 Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1<\/p>\nISO 14698-2<\/strong>
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