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1. Personal Information
Street / P.O. Box*
2. What are your responsibilities respectively your interests in the field of microbiology?
Change control management
Container Closure Integrity
Developments in other industrial sectors
Hold time validation
Identification of Microorganisms
Non Sterile Testing
Regulatory / Registration
Sterilisation process validation
3. If you use alternative/rapid methods in your laboratory/company.
BD Baxtec FX
BacT/ALERT 3D Dual-T
Endosafe®-PTS Gram ID
Endosafe®-PTS glucan assay
MicroSEQ® Microbial Identification System
MicroSEQ® Mycoplasma Identification System
Pallchek Rapid Microbiology System
RiboPrinter® microbial characterization system
Sherlock® Microbial Identification System (MIS)
VITEK 2 compact
Others? Which one
4. You use it for ...:
In Process Control
5. Have you submitted application of alternative/rapid method to your competent authority?
6. For which type of product(s)?
Application of alternative culture media - R+D and validation/ qualification of these media
Non-sterile liquids, creams and ointments
Solutions for infusion
7. How many of the submitted applications were approved by the competent authority?
More? How many
8. Which compendia methods have you replaced by alternative/rapid methods?
Tests of EP 2.6.12 and 2.6.13 for Non Sterile Products
9. What are your expectations as a member of ECA's RMM Working Group?
Information about current system developments/ news systems
Information about regulatory developments
Information about experiences in validation and approval
Courses and Conference about this topics
Additional Best Practice Papers
Regularly updated Database on available systems
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