LABORATORY

MedicalGroup laboratory carries out numerous physico-chemical, microbiological, and packaging tests, most of which are COFRAC-accredited (ISO 17025).

Accréditation No 1-6644
Scope available on
www.cofrac.fr

We also support you with certain specific projects, according to your needs. Our human-scale team responds quickly to your questions, providing comprehensive follow-up and personalized advice on every step of your project.

Proactive and available, we commit to meeting deadlines. We provide ongoing monitoring of your file, remaining close at hand.

Our in-depth knowledge of standards and regulations is strengthened by regular monitoring. Therefore, we also advise you on these various aspects, their developments, and their impacts on your business.

We commit to long-term support, with a transparent and reliable relationship.

Packaging tests

You would like to:

  • check the sterile barrier of your medical device packaging or products,
  • carry out a validation of your packaging to ensure it meets your needs,
  • validate new sealing equipment (bag sealing machine, blisters, etc.)

We assist you in drafting your protocols and offer you different tests:

Seal strength test*
⤷ NF EN 868-5 and ASTM F88/ F88M

Visual inspection*
⤷ ASTM F1886/F1886M

Manual peel test*
⤷ NF EN 868-5

Seal leak test*
⤷ ASTM F1929 and ASTM F3039

Syringe leak test
⤷ ISO 11040-6

Accelerated aging
⤷ ASTM F1980

Transportation simulation
⤷ ASTM D4169 and ISTA

Microbial barrier
⤷ ASTM F1608

Bubble test
⤷ ASTM F2096

* Test performed under COFRAC accreditation

Microbiology tests

IBC (Initial Bioburden Count)*
⤷ Search for Initial Biocontamination on a medical device or product BEFORE sterilization according to ISO 11737-1. Random selection.

Sterility tests*
⤷ Macroscopic detection of the presence or absence of at least one microorganism that survived the sterilization process according to ISO 11737-2 or Ph. Eur. 2.6.1 or USP<71>. Medical devices or products are randomly selected and AFTER sterilization.

Endotoxin testing (LAL test)*
⤷ Detection of Gram-negative bacterial endotoxins using horseshoe crab amebocyte lysate, in accordance with Ph. Eur. 2.6.14 or USP<85> or <161> and ISO 11737-3. This lysate coagulates if endotoxins are present on the surface of the medical device or product, causing a yellow coloration.

Initial / routine dose audit
⤷ Calculation of the sterilizing dose to be applied in routine dose audits. Verification that the sterilizing dose is sufficient for product sterilization.

Identification of microorganisms
⤷ Bacteria, yeasts, and molds

Cytotoxicity
⤷ Assessment of the cytotoxic potential of a medical device on cell growth or induction of cell death.

* Test performed under COFRAC accreditation

Physico-chemical tests

Characterization of ceramic powders and coatings using XRD according to ISO 13779-3*
⤷ Determination of crystallinity ratio
⤷ Quantification of foreign phases
⤷ Ca:P ratio

Analysis of TiN in titanium

Measurement of alpha and gamma phases in alumina

Chemical analyses
⤷ Elemental analysis using ICP (OES and MS) in accordance with
ISO 13779-3
⤷ HAP solubility product (Ksp) according to ISO 13779-6
⤷ Dissolution rate according to ASTM F1926/F1926M
⤷ IR analysis, as per FDA guidance
⤷ Chemical analysis using IC, ICP, HPLC, HCT, TOC (medical devices)

Optical microscope examination of the coating*
Single and double coating (HAP, Titanium, Alumina) according to ASTM F1854 (micro-saw cutting, cold mounting, and polishing)
⤷ Thickness measurement
⤷ Determination of volumetric pore percentage
⤷ Pore size measurement

Roughness measurement using a profilometer, according to standard NFS 94-071

Observation of HAP powder grain shape

Scanning Electron Microscope

Particle counting

Mechanical tests
⤷ Tensile adhesion according to ASTM F1147*
⤷ Static shear adhesion according to ASTM F1044*
⤷ Dynamic shear adhesion according to ASTM F1160*
⤷ TABER abrasion according to ASTM F1978*

* Test performed under COFRAC accreditation

Our support

①   Market launch projects

  • Identify the mandatory tests to include in your files
  • Help you respond to questions or non-conformities from your Notified Bodies

②   Expertise

  • Resolve, analyze the cause of an issue you are facing with your product(s)
  • Improve the control of your cleanroom environment by identifying best practices or assisting you in the risk analysis you have implemented

③   Evolving standards

  • Identify changes when a standard evolves
  • Determine the impacts for you
  • How to translate them into concrete actions

Consulting audit

Carry out a “consulting audit” on part of your process to identify gaps relative to a reference framework and advise you on actions to implement.

Training

Offer you training on microbiology, best practices in cleanrooms, and other topics related to your activities.

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