June 2015
Pharma & Medical Device


  Genotoxicity tests for medical devices: the changes in ISO 10993-33:2015  

The new Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3, is the most relevant standard to evaluate the potential genotoxicity, carcinogenicity, or reproductive toxicity for medical devices.


Since chemicals can induce genetic damage by different mechanisms, a battery of tests sensitive to different types of genetic damage are thought to provide the best assurance for detecting genotoxic hazard. All assays reported below are suitable for medical devices according to OECD guidelines.The tests described in details include:

a) a test for gene mutations in bacteria (Ames test, OECD 471) and
b) an in vitro test chromosome aberration test for chromosomal damage (OECD 473), or
c) an in vitro mouse lymphoma tk assay (OECD 476), or
d) an in vitro mammalian cell micronucleus test for chromosomal damage and aneugenicity (OECD 478).

In vivo tests are also described and are sometimes incorporated into test batteries. These tests are sometimes included in the initial test battery or are used to clarify results from in vitro tests.

It is emphasized the necessity of an adequate approach on selecting sample preparation procedure, as already described in Annex A (informative) of ISO 10993-3 published in October 2014. Inappropriate sample preparation could lead to an underestimation of genotoxicity risk, and therefore the selection of the appropriate sample preparation is crucial. Three methods are described: beside dissolution or suspension of the test item in an adequate solvent and simulated-use extraction, a new challenging method -"Method B" encompassing extraction in two or more solvents is investigated.

Link to Guidance on tests to evaluate genotoxicity

Mérieux NutriSciences is a valued partner to the global healthcare industry and can support you by designing testing strategies as well as performing genotoxicity studies.


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  Mérieux NutriSciences GxP Unit in Italy announce the implementation of the new LIMS LabVantage 6
  The GxP Unit is going to improve the actual SQL LIMS with the new LabVantage 6 version, enhancing speed and quality in data entry, data management, approvals, statistics, reporting and querying.

LabVantage 6 is validated CFR 21 part 11 and Annex 11 EU GMP and is ideal for quality labs in a regulated environment. It allows to define a set of key performance indicators accessible through easy reporting or more sophisticated business intelligence tools facilitating constant monitoring of process performance and detecting any deviation from the desired outcome.

LabVantage 6 works with integrated barcoding, eSignature functionality for approval process and will be interfaced with several instruments and the Electronic Laboratory Notebook.

Our customers will benefit of many advantages with the new LIMS:

Automatic receipt of digitally signed Test Report after QP approval
Secure remote consultation of LIMS own raw data and results after QC approval
Online pre-log of samples using an electronic interface (substituting the current paper Chain of Custody)

  How to address the evaluation of the inner surface durability of glass containers

The recent product recalls have further heightened the pharmaceutical industry’s awareness of the need of evaluation of glass quality and glass delamination (i.e., the formation of glass flakes in a vial). In response to that USP has published a new general information chapter which recommends the analytical approaches to predict the potential formation of glass particles and delamination.

Glass delamination, which ultimately results in the appearance of lamellae, is a lagging indicator of structural instability of a container. Although delamination is the most obvious visual indicator of instability, it represents the final stage of a seriously weakened glass surface structure, and can be observed only at a point where prevention is no longer possible, making the batch rejection necessary. Hence a meticulous evaluation of the quality of glass containers is crucial when this packaging is used.


Mérieux NutriSciences solutions in compliance with USP requirements

Mérieux NutriSciences in Italy has an in-depth knowledge on the previous approach required by USP and has developed all the analytical services in compliance with the new chapter . A study protocol will be designed together with the customer which includes stress conditions and methods for determining the relevant targets.

Aggressive or in-use screening condition:

Aggressive solutions for preliminary screening materials / suppliers: eg. EDTA or Citric Acid or solutions indicated in Table 4 of the USP, other solutions agreed with the Sponsor;

Simulants solutions for finished products: solutions prepared according to the criteria given in Table 5 of USP and / or information provided by the Sponsor based on the type of pharmaceutical product and storage conditions applicable;

Under aggressive screening condition for accelerated delamination: to be defined according to the type of formulation used and the purpose of the analysis

Mérieux NutriSciences can use a number of different technologies to examine the three key parameters: visual examination and chemical profile of the inner surface layer, the amount and identity of extracted elements in solution, and the number of subvisible and visible particles in solution.

Analytical Techniques for screening studies after storage conditions:

Glass inner surface mapping by SEM-EDX

Si / SiO2 (and other elements) in solution by ICP-MS or ICP-AES

pH of solution

Conductivity of solution

Lamellae / visible particles by visual examination

Subvisibile glass particles using particle counter and/or SEM

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Amino Acids Analysis services: Glycine Ph Eur 0614, change from 01/2008 to 07/2015

In the new edition of the European Pharmacopoeia, TLC test for the determination of ninhydrin positive substances is replaced with an instrumental method by amino analyzer (AAA). It’s a complex technic that requires years of proven experience and specific equipments.

Mérieux NutriSciences in Italy performs this test in cGMP according to the new compendial metodology.


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  Viral Safety & Raw Materials Congress - Vienna    
  Join us at Viral Safety and Raw Materials Congress in Vienna to share with our Senior and Lab-Level scientist representatives common problems and long-term solutions about Viral Clearance.

Start: June 24
End: June 25
Organizer: Informa Life Sciences



Chelab Srl, a Mérieux NutriSciences Company

Via Fratta 25 - 31023 TV - Resana - Italy - Tel.: +39 0423 7177 - Fax: +39 0423 715058