ISPE Spain Affiliate


Inspección y Revisión de Estériles


                                Barcelona                                                                Madrid 

Wednesday, 14 June 2017, at 9:00 a.m.           Thursday, 15 June 2017, at 9:00 a.m. 

                             Inibsa                                                                      Pfizer



9:00 Reception


9:25 Welcome

        Oriol Argemi, ISPE Spain Affiliate


 9:30 Particles & Fibers detection in CZ plastic cartridges and syringes filled with

         viscous product – A practical case

         Massimo Frasson, General Manager, Brevetti CEA

TOPIC KEY WORDS: CZ Plastic PFS, CZ plastic cartridges, particles & fibers detection, viscous
product, automatic inspection

Contaminates such as particles and fibers often represent a challenge in terms of detection,
especially in case of high viscosity products.
The application of plastic containers within the pharmaceutical production lines is constantly
increasing, arising further new difficulties by the inspection world.

Standard inspection techniques used to detect particles and fibers contained in glass containers
can not be applied on plastic containers.
Key topic is presenting a case study based on the direct experience of a major international
pharmaceutical Company.
The presentation will describe in details the right approach and possible solutions to reach
successful inspection performances in CZ plastic cartridges and syringes filled with viscous
Auditors will have the chance of seeing real images and videos of the technique applied in this
specific case.
Speakers will show and explain how the combination of special lights, algorithms and high
resolution cameras can positively affect the inspection results.

10:15 Inspection of milky and Viscous products in LVP   

           Gaetano Baccinelli, Optrel


11:00 Coffee Break


11:20 Container Closure Integrity Testing: Ensuring purity in parenterals  

          Rupert Depner, Seidenader Maschinenbau, GmbH

           We will highlight some aspects of CCI, a topic of growing interest.

           What is CCI? Sterile product–package integrity (or container closure integrity) is the ability of a

           sterile product container–closure system to keep product contents in, while keeping detrimental

           environmental contaminants out. (USP 1207)

           How can you test CCI? Solutions for liquid- and for lyo products.


12:05 100% container closure integrity (CCI) testing using

          headspace analysis or vacuum decay method

           Dr. Wolfram Schindler, Bosch Packaging Technology

  Defect types and leak sizes

  Physical fundamentals of the testing methods laser-based headspace analysis and vacuum decay

  Selection of the right method according to the product requirements and properties


12:40  Workshop Wrap-Up

           Oriol Argemi, ISPE Spain Affiliate


12:45 Plan visit: Inibsa in Barcelona. Pfizer Biotech in Madrid


14:00 Lunch/ Branch



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