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unjour unlabo a Day, a Lab - 12 December 2017, Lyon

  • Theme : The new bulk injectable water monograph: regulatory and technological challenge
  • Charles River Laboratory Visit




In 2017, and after so many years of discussion, a new monograph on EPPIV is published by the European Pharmacopoeia. But it seems that in order to implement this new monograph, the EMA has to publish a text on the proper use of membrane systems to produce the EPPIV.
This document should be included in Annex 1. It appears that the EMA is not convinced of the robustness and efficiency at 100% of the time of these EPPIV production membrane systems.

This day should allow us to discuss this new monograph on L'EPPIV.

A little history concerning the appearance of the new monograph on Water for Injectable Bulk Preparations (EPPIV):

1969: Introduction to the 1 edition of the European Pharmacopoeia of Purified Water (EP). It is produced by distillation, ion exchange or any other equivalent technology
1973: Introduction to the 1 edition of the European Pharmacopoeia for Injectable Preparations (EPPI). It is produced only by distillation
1976: USP accepted reverse osmosis as an alternative method to produce EPPI
1983: Appearance of the 2th edition of the European Pharmacopoeia 5th Addendum, EPPI is still produced by distillation, but the discussion is launched to produce EPPI by RO / RO
1999: Discussion between EDQM_EMEA and USP_FDA
2002: Appearance of Highly Purified Water (EHP) in the 4th edition of the European Pharmacopoeia. It is produced by membrane systems (RO / EDI / UF or RO / RO / UF)
2004: USP modifies EPPI monograph by eliminating text from membranes
2016: New EPPIV monograph authorizing membrane systems, PE 9 



A3P One Day, One Lab - Tuesday 12 December 2017
Mercure Perrache,
12 Courses of Verdun Rambaud, 69002 Lyon



08h30 Welcome of participants
  User feedback on the production of high purity water by membrane process: Operational aspects and maintenance aspects
 Robert Néri - RNC

Membrane techniques for the production of water in the pharmaceutical industry
 Cécile Valentin - GE Water

  Technical and economic implications of the revision of the WFI monograph (0169)
 Pierre Cullmann - BWT
  Alternative Methods to Produce WFI, the Global History, and Impact to Patient
 Anthony Bevilacqua - Mettler Toledo

Determination of endotoxins on process water in the quality control laboratory using rapid cartridge methods
 Aurélien Broly - Merck  

 14h00  Visit of Charles River Laboratory in 7 workshops:
  • Rapid microbial detection:

Demonstration of a Microbial Limit Test (MLT) by amplified ATPmetry method, presentation of associated reagents and operating software

  • Automation / robotization of the fast LAL test:

Launch of a fully automated endotoxin assay in cartridge method with the Nexus robot, detail of the robotization system including a pipette / automatic diluter and a gripper arm, description of LAL cartridges for LAL pharmacopoeial test

  • Tour of the Endotoxin Dosage Laboratory:

Presentation of the various pharmacopoeial methods used in the laboratory (colorimetry, turbidimetry, gel, cartridges) as well as the different types of samples treated (medical devices, medicines ...) and strategies used to solve interference problems

  • Microbial identification in mass spectrometry (Maldi Tof):

Presentation of the Maldi Tof apparatus of the laboratory, reminder of the Maldi Tof method for identification in microbiology, real-time realization of microbial identification and spectrum interpretation using the Charles River database

  • Microbial identification in sequencing method:

Explanation of the different stages of identification by sequencing (purification, amplification ...), description of our dematerialized data management tool, focus on interpretation of sequencing data, presentation of our trend tracking tool

  • Presentation of activities Microbial solutions:

The Ecully site of Microbial Solutions offers laboratory activities (microbial identification, LAL test), technical support, customer service training and distribution for the EMEA area ... More from 50 people support this structure. Let's start with the discovery of this site and the key figures of our activities

  • Tof the distribution site:

Our distribution platform has processed in 2016 more than 12000 commands concerning 250 references. Come and discover our 1000 m2 store designed to meet the FDA criteria

17h00 End of the event

 Contact :
Ludivine BAYLE
04 37 28 30 40
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