Qualification Archieven

Commissioning & qualification of new aseptic filling area (according E2500 verification approach)

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' id='items' color='main_color' custom_bg='' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_uid='av-ntgclj']

[av_hr class='invisible' height='30' shadow='no-shadow' position='center' custom_border='av-border-thin' custom_width='50px' custom_border_color='' custom_margin_top='30px' custom_margin_bottom='30px' icon_select='yes' custom_icon_color='' icon='ue808' font='entypo-fontello' av_uid='av-mje98n']

[av_one_half first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' padding='0px' border='' border_color='' radius='0px' background_color='' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_display='' av_uid='av-j4y9j']

[av_image src='http://dev.phenx.be/wp-content/uploads/2020/01/Foto-D2.png' attachment='3969' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2020/01/Foto-E2.png' attachment='3970' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[/av_one_half][av_one_half min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' padding='0px' border='' border_color='' radius='0px' background_color='' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_display='' av_uid='av-kuj42f']

[av_heading heading='About the project' tag='h3' link_apply='' link='' link_target='' style='blockquote modern-quote' size='' subheading_active='' subheading_size='15' margin='' padding='10' color='' custom_font='' custom_class='' id='' admin_preview_bg='' av-desktop-hide='' av-medium-hide='' av-small-hide='' av-mini-hide='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' av-medium-font-size='' av-small-font-size='' av-mini-font-size=''][/av_heading]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-gte27r' id='' custom_class='' admin_preview_bg='']
Client: Confidential
Location: Belgium (Brussels area)
Completion: 2019 -
Total Investment Cost: Confidential
[/av_textblock]

[av_heading heading='Project description' tag='h4' link_apply='' link='manually,http://' link_target='' style='' size='' subheading_active='' subheading_size='15' margin='' padding='10' color='' custom_font='' custom_class='' id='' admin_preview_bg='' av-desktop-hide='' av-medium-hide='' av-small-hide='' av-mini-hide='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' av-medium-font-size='' av-small-font-size='' av-mini-font-size=''][/av_heading]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-efskkn' id='' custom_class='' admin_preview_bg='']

Implementation of new Aseptic Vials Filling Line (incl. Washing machine, depyroogenization tunnel, filling line, capping machine) in a new Filling area as part of an extension of the current production building.

[/av_textblock]

[av_heading heading='Provided services' tag='h4' link_apply='' link='manually,http://' link_target='' style='' size='' subheading_active='' subheading_size='15' margin='' padding='10' color='' custom_font='' custom_class='' id='' admin_preview_bg='' av-desktop-hide='' av-medium-hide='' av-small-hide='' av-mini-hide='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' av-medium-font-size='' av-small-font-size='' av-mini-font-size=''][/av_heading]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-ahxm9j' id='' custom_class='' admin_preview_bg='']

Commissioning and Qualification according E2500 verification approach (including project qualification strategy, URS, FAT, SAT, verification test protocols and test scripts).

[/av_textblock]

[av_heading heading='Serviced packages' tag='h4' link_apply='' link='manually,http://' link_target='' style='' size='' subheading_active='' subheading_size='15' margin='' padding='10' color='' custom_font='' custom_class='' id='' admin_preview_bg='' av-desktop-hide='' av-medium-hide='' av-small-hide='' av-mini-hide='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' av-medium-font-size='' av-small-font-size='' av-mini-font-size=''][/av_heading]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-836rfb' id='' custom_class='' admin_preview_bg='']

Utilities/ Facilities: HVAC, WFI, clean steam and clean compressed air distribution

Automation: AMS, EMS, Interlocking

Equipment: Integrated Filling Line (incl. Washing Machine, Depyrogenization Tunnel, Filling Line, Capping Machine ), Autoclave, Vessel docking station, VHP decontamination units

[/av_textblock]

[/av_one_half][/av_section]

by Heleen Vandermeeren

Commissioning & qualification of new fill & finish / CQ lab facility

[av_image src='http://dev.phenx.be/wp-content/uploads/2020/01/Website-PhéNX-21.png' attachment='3960' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2020/01/Foto-C-1.png' attachment='3962' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2020/01/Website-PhéNX-20.png' attachment='3963' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-gte27r' id='' custom_class='' admin_preview_bg='']
Client: Novasep
Location: Belgium (South)
Completion: 2019 -
Total Investment Cost: ca. 10m €
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-efskkn' id='' custom_class='' admin_preview_bg='']

Implementation of new Green Field Aseptic Fill & Finish /QC Lab facility (1800m²), dedicated to the aseptic filling of a wide range of biological products (viral vectors, viruses, monoclonal antibodies and other biologicals). This new Fill and Finish unit features semi-automatic and automatic liquid filling machines under isolator. Also visual inspection and QC lab activities and foreseen in this new facility.

[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-ahxm9j' id='' custom_class='' admin_preview_bg='']

Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).

[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-836rfb' id='' custom_class='' admin_preview_bg='']

Utilities/ Facilities: HVAC, Purified Water distribution, Clean gasses (Compressed Air, CO2, O2, N2) distribution

Equipment: Filling Line, Isolator, Autoclave, LAFs, Freezers, Incubators, Cold rooms, Biosafety Cabinets

Automation: AMS, EMS, Interlocking

[/av_textblock]

[/av_one_half][/av_section][av_one_half first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' title_attr='' alt_attr='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-3i1z92']
[av_video src='https://youtu.be/79rSPzVuoTQ' mobile_image='' attachment='' attachment_size='' format='16-9' width='16' height='9' conditional_play='' av_uid='av-k5z9mhdu' id='' custom_class='']
[/av_one_half]

[av_one_half min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' title_attr='' alt_attr='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-2bw26u']
[av_video src='https://youtu.be/VrjfQWhUlMs' mobile_image='' attachment='' attachment_size='' format='16-9' width='16' height='9' conditional_play='' av_uid='av-k5z9mhdu' id='' custom_class='']
[/av_one_half]

by Heleen Vandermeeren

Implementation of new high potent drug product production unit

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/03/CASE3-495x400.jpg' attachment='3843' attachment_size='portfolio' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/Website-PhéNX-13.png' attachment='3942' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/Website-PhéNX-14.png' attachment='3944' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-gte27r' id='' custom_class='' admin_preview_bg='']
Client: Confidential
Location: Belgium (North)
Completion: 2019
Total Investment Cost: Confidential
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-ahxm9j' id='' custom_class='' admin_preview_bg='']
Concept study, Basic and Detailed Design, Procurement, Construction Management and Commissioning/Qualification.
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-836rfb' id='' custom_class='' admin_preview_bg='']
HVAC, Clean Rooms Finishes, Utilities, Electrical, EMS and integration of Isolator technology.
[/av_textblock]

[/av_one_half][/av_section]

by Heleen Vandermeeren

Commissioning & qualification of new viral vector production unit

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/CASE-2-2a.png' attachment='3929' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/Website-PhéNX-10.png' attachment='3930' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/03/CASE2-495x400.jpg' attachment='3842' attachment_size='portfolio' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-gte27r' id='' custom_class='' admin_preview_bg='']
Client: Novasep
Location: Belgium (South)
Completion: 2019
Total Investment Cost: ca. 27m€
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-efskkn' id='' custom_class='' admin_preview_bg='']
Implementation of new Green Field Viral Vector Production facility, including 2 cGMP production units. One unit is dedicated to adherence cell culture for viral vectors in moderate quantities (to treat certain rare diseases or for lower dose indications and one unit for suspension cell culture with bioreactors up to 2000L to produce larger quantities.
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-ahxm9j' id='' custom_class='' admin_preview_bg='']
Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).
[/av_textblock]

[av_textblock size='' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-836rfb' id='' custom_class='' admin_preview_bg='']
Utilities/ Facilities: HVAC, Purified Water production and distribution, Clean gasses (Compressed Air, CO2, O2, N2) production and distribution

Process Equipment: Bioreactors, Clarification skids, (Ultra)filtration skids, chromato skids, buffer prep skids

Automation: AMS, EMS, Interlocking

Support Equipment: Decontamination System, Decontamination autoclave, Sterilisation autoclave, LAF cabinets, Biosafety Cabinets
[/av_textblock]

[/av_one_half][/av_section][av_one_third first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' title_attr='' alt_attr='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-5zm7o5']
[av_video src='https://youtu.be/S_svyotEL_A' mobile_image='' attachment='' attachment_size='' format='16-9' width='495' height='400' conditional_play='' av_uid='av-k5z7r6cp' id='' custom_class='']
[/av_one_third]

[av_one_third min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' title_attr='' alt_attr='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-4pwjud']
[av_video src='https://youtu.be/1hEyXjgmCmw' mobile_image='' attachment='' attachment_size='' format='16-9' width='495' height='400' conditional_play='' av_uid='av-k5z7r6cp' id='' custom_class='']
[/av_one_third]

[av_one_third min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' title_attr='' alt_attr='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-2bkp4l']
[av_video src='https://youtu.be/e7vf6lXLNvg' mobile_image='' attachment='' attachment_size='' format='16-9' width='495' height='400' conditional_play='' av_uid='av-k5z7r6cp' id='' custom_class='']
[/av_one_third]

by Heleen Vandermeeren

Commissioning & qualification of new vaccine production unit

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/CASE-1-1-495x400.jpg' attachment='3749' attachment_size='portfolio' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-4ttd87' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/foto-A-495x400.jpg' attachment='3924' attachment_size='portfolio' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-k5z6ryr3' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_image src='http://dev.phenx.be/wp-content/uploads/2019/11/case1_3.png' attachment='3926' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-k5z6ryr3' id='' custom_class='' admin_preview_bg=''][/av_image]

[av_textblock size='' font_color='' color='' av_uid='av-gte27r']
Client: Confidential
Location: Belgium (Brussels)
Completion: 2018
Total Investment Cost: ca. 65m€

[/av_textblock]

[av_textblock size='' font_color='' color='' av_uid='av-efskkn']
Implementation of new Vaccine production unit in an existing facility. Increase of capacity from 34 to 56 million doses.

[/av_textblock]

[av_textblock size='' font_color='' color='' av_uid='av-ahxm9j']
Assistance of General contractor Vinci group for commissioning/qualification and document management activities.

[/av_textblock]

[av_textblock size='' font_color='' color='' av_uid='av-836rfb']
Clean Utilities (Purified Water; Water for Injection, Pure Steam, Compressed Air, NaOH, Biowaste, Process Drain systems).

Process Equipment (Media - buffer prep vessels, media hold vessels, buffer hold vessels, pooling vessels, final filtration, clarification)

Process automation

[/av_textblock]

[/av_one_half][/av_section]

by Heleen Vandermeeren