Quimico farmacéutico biólogo
Introduction for Dr Sabido October 12, 2009
Key messages on Aseptic Technologies
• Developed a revolutionary concept to provide
SAFER &EASIER aseptic filling operations, based on the closed vial technology
• Out-license vial manufacturing: ensuring multiAseptic Technologies
sourcing and fair competition on prices
• Focus onthe equipment able to process the
closed vial. Three formats of filling lines available: from 400 up to 36,000 vials/hour
• Launched a Validation Master Plan to support
approval of the lines andthe vials
Confidential | Copyright © 2009 | Aseptic Technologies | All rights reserved
Key messages on Crystal® Technology
• Ready-to-fill vial manufactured in Class 100/A
and Gammairradiated
• Filling performed through the stopper, which is
then immediately re-sealed by laser Crystal® Technology
• Fully validated by Authorities • Offers key advantages:
–SAFER for the patient–EASIER for the manufacturer
Confidential | Copyright © 2009 | Aseptic Technologies | All rights reserved
Concept of Crystal® | Process | 3 different sites
Plastic Molder Irradiation unitMolding & Closing (Class 100/A/ISO 5)
Assembling (Class 10,000/C/ISO 8)
Sterilization (Gamma irradiation)
Pharmaceutical site
Filling line under barrier (Class 100/A/ISO 5)
Clean & sterile“ready to fill” vial
Capping
Laser re-sealing
Filling
Confidential | Copyright © 2009 | Aseptic Technologies | All rights reserved
The Crystal® Closed Vial technology
Key advantages overclassical glass vial
R&D
Improved stability for products sensitive to alkaliions (biopharmaceuticals) CapEx and utilities reduced Simpler aseptic filling operations and no up-stream processesSimplified validation Preferred by end-users Closed and unbreakable container Increased quality for the patient
Finance Manufacturing
QA Marketing Supply chain Regulatory
Confidential |...
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