FILLING SOLUTIONS
ASEPTIC TECHNOLOGIES
SAFER PARENTERALS
Over the years, BioPharmaceutical companies have taken
measures to provide the highest quality to their patient
Consequently, to ensure such level of quality,
huge, complex and risky equipment is operated
SAFER PARENTERALS
New products and
therapies have imposed
new manufacturing and
quality challenges
For that reason, Aseptic Technologies has been set up in 2002
SAFER PARENTERALS
For that reason, Aseptic Technologies has been set up in 2002
with the mission to bring innovative solutions to aseptic filling operations.
SAFER PARENTERALS
OUR EXPERTISE
Aseptic Filling Technology
(AT-Closed Vial® Technology)
OUR EXPERTISE
Aseptic Filling Technology
(AT-Closed Vial® Technology)
OUR EXPERTISE
Manufacturing of Kits
and Devices for Aseptic Filling
Aseptic Filling Technology
(AT-Closed Vial® Technology)
OUR EXPERTISE
Manufacturing of Kits
and Devices for Aseptic Filling
Aseptic Liquid Transfer
Systems
100
2002
Creation of
Aseptic
Technologies
2003
Presentation of
the concept to
EMA and FDA
2005
Presentation
of validation
results to FDA
2007
Contract filling
approved at AT
by EMA
2009
1st equipment
installed in the
United States
2011
Skan group
collaboration
2013
80% of GSK
vaccines through
AT-Port™
2015
1st equipment
installed in
Japan
2016
100th equipment
installed
2010
1st equipment
installed in
Europe
ASEPTIC TECHNOLOGIES
MILESTONES
Our solutions are for years used for manufacturing of biopharmaceutical
products: cell&gene theapies, vaccines, antibodies…
USERS OF OUR TECHNOLOGY
POSITION IN THE WORLD
AT-CLOSED VIAL
®
TECHNOLOGY
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
And now inside grade A it will be:
1) Filled through the stopper
1
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
And now inside grade A it will be:
1) Filled through the stopper
2) Then re-sealed by a laser
1 2
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
And now inside grade A it will be:
1) Filled through the stopper
2) Then re-sealed by a laser
3) And capped
AT-Closed Vial®
is supplied to
biopharma manufacturer
ready-to-fill and closed
1 2
AT-Closed Vial®
is filled, capped
and ready for next
processing steps
1 2 3
AT-CLOSED VIAL® TECHNOLOGY
CONCEPT
…offering a solution easy to launch and to scale-up:
with a complete range
of vials formats (1-50ml)
AT-CLOSED VIAL® TECHNOLOGY
FILL&FINISH EQUIPMENT
MANUFACTURING OF KITS
AT-FILLING KIT™
Manufacturing of ready-to-use kits and devices for aseptic filling of
injectable products
AT-Filling Kit™ is
• clean assembly of tubing, needle and other elements
• supplied in double PE bags, Gamma irradiated
• standard or customized
ASEPTIC LIQUID TRANSFER
AT-PORT™
AT-PORT™ a smart connecting system allowing
safe liquid transfer across a wall between two areas
with different containment classifications
Combined with connector Gamma-Sart™
commercialized by
HIGHLIGHTS AND NEW HORIZONS
HIGHLIGHTS 2016
Our 100th filling
equipment installed
First users of
AT-Closed Vial® Technology
in Canada and Russia,
Scaling-up in Japan
First application of
AT-Closed Vial® Technology
in Nanomedicine by Midatech
Pharma (ES)
Automated Thawing device
by Biocision (US) is available
UPCOMING
…and much more.
To stay updated:
Subscribe to our Newsletter
Follow our page on LinkedIn
PARC SCIENTIFIQUE CREALYS
Rue Camille Hubert 7 | B-5032 Gembloux | Belgium
T. +32 81 409 465 | F. +32 81 409 41
www.aseptictech.com
25
Copyright by Aseptic Technologies S.A., Gembloux, Belgium.
All rights reserved. All text, images, graphics, animation, videos, and other materials on
this document are subject to the copyright and other intellectual property rights of
Aseptic Technologies S.A. These materials may not be reproduced, distributed,
modified, reposted or translated in any form or by any means without the prior written
permission of Aseptic Technologies S.A.
The status of the information, specifications and illustrations in this presentation is
indicated by the date given below. Aseptic Technologies S.A. reserves the right to make
changes to the technology, features, specifications, and design of the equipment
without notice.
Status: January 2017, Aseptic Technologies S.A., Gembloux, Belgium
DISCLAIMER

Aseptic Technologies | Overview

  • 1.
  • 2.
    SAFER PARENTERALS Over theyears, BioPharmaceutical companies have taken measures to provide the highest quality to their patient
  • 3.
    Consequently, to ensuresuch level of quality, huge, complex and risky equipment is operated SAFER PARENTERALS New products and therapies have imposed new manufacturing and quality challenges
  • 4.
    For that reason,Aseptic Technologies has been set up in 2002 SAFER PARENTERALS
  • 5.
    For that reason,Aseptic Technologies has been set up in 2002 with the mission to bring innovative solutions to aseptic filling operations. SAFER PARENTERALS
  • 6.
  • 7.
    Aseptic Filling Technology (AT-ClosedVial® Technology) OUR EXPERTISE
  • 8.
    Aseptic Filling Technology (AT-ClosedVial® Technology) OUR EXPERTISE Manufacturing of Kits and Devices for Aseptic Filling
  • 9.
    Aseptic Filling Technology (AT-ClosedVial® Technology) OUR EXPERTISE Manufacturing of Kits and Devices for Aseptic Filling Aseptic Liquid Transfer Systems
  • 10.
    100 2002 Creation of Aseptic Technologies 2003 Presentation of theconcept to EMA and FDA 2005 Presentation of validation results to FDA 2007 Contract filling approved at AT by EMA 2009 1st equipment installed in the United States 2011 Skan group collaboration 2013 80% of GSK vaccines through AT-Port™ 2015 1st equipment installed in Japan 2016 100th equipment installed 2010 1st equipment installed in Europe ASEPTIC TECHNOLOGIES MILESTONES
  • 11.
    Our solutions arefor years used for manufacturing of biopharmaceutical products: cell&gene theapies, vaccines, antibodies… USERS OF OUR TECHNOLOGY POSITION IN THE WORLD
  • 12.
  • 13.
    AT-Closed Vial® is suppliedto biopharma manufacturer ready-to-fill and closed AT-CLOSED VIAL® TECHNOLOGY CONCEPT
  • 14.
    AT-Closed Vial® is suppliedto biopharma manufacturer ready-to-fill and closed And now inside grade A it will be: 1) Filled through the stopper 1 AT-CLOSED VIAL® TECHNOLOGY CONCEPT
  • 15.
    AT-Closed Vial® is suppliedto biopharma manufacturer ready-to-fill and closed And now inside grade A it will be: 1) Filled through the stopper 2) Then re-sealed by a laser 1 2 AT-CLOSED VIAL® TECHNOLOGY CONCEPT
  • 16.
    And now insidegrade A it will be: 1) Filled through the stopper 2) Then re-sealed by a laser 3) And capped AT-Closed Vial® is supplied to biopharma manufacturer ready-to-fill and closed 1 2 AT-Closed Vial® is filled, capped and ready for next processing steps 1 2 3 AT-CLOSED VIAL® TECHNOLOGY CONCEPT
  • 17.
    …offering a solutioneasy to launch and to scale-up: with a complete range of vials formats (1-50ml) AT-CLOSED VIAL® TECHNOLOGY FILL&FINISH EQUIPMENT
  • 18.
  • 19.
    AT-FILLING KIT™ Manufacturing ofready-to-use kits and devices for aseptic filling of injectable products AT-Filling Kit™ is • clean assembly of tubing, needle and other elements • supplied in double PE bags, Gamma irradiated • standard or customized
  • 20.
  • 21.
    AT-PORT™ AT-PORT™ a smartconnecting system allowing safe liquid transfer across a wall between two areas with different containment classifications Combined with connector Gamma-Sart™ commercialized by
  • 22.
  • 23.
    HIGHLIGHTS 2016 Our 100thfilling equipment installed First users of AT-Closed Vial® Technology in Canada and Russia, Scaling-up in Japan First application of AT-Closed Vial® Technology in Nanomedicine by Midatech Pharma (ES) Automated Thawing device by Biocision (US) is available
  • 24.
    UPCOMING …and much more. Tostay updated: Subscribe to our Newsletter Follow our page on LinkedIn PARC SCIENTIFIQUE CREALYS Rue Camille Hubert 7 | B-5032 Gembloux | Belgium T. +32 81 409 465 | F. +32 81 409 41 www.aseptictech.com
  • 25.
    25 Copyright by AsepticTechnologies S.A., Gembloux, Belgium. All rights reserved. All text, images, graphics, animation, videos, and other materials on this document are subject to the copyright and other intellectual property rights of Aseptic Technologies S.A. These materials may not be reproduced, distributed, modified, reposted or translated in any form or by any means without the prior written permission of Aseptic Technologies S.A. The status of the information, specifications and illustrations in this presentation is indicated by the date given below. Aseptic Technologies S.A. reserves the right to make changes to the technology, features, specifications, and design of the equipment without notice. Status: January 2017, Aseptic Technologies S.A., Gembloux, Belgium DISCLAIMER