Quimico farmacéutico biólogo

Páginas: 3 (556 palabras) Publicado: 6 de marzo de 2012
Introduction to the Crystal® Closed Vial Technology

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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