A global solution for all your needs: From risk analysis to analytical testing.
Nettoyage
Packaging
Stérilisation
Biocompatibilité
Une étude complète Interaction Contenant Contenu suppose l’évaluation de la stabilité du produit dans son conditionnement :
- Stabilité : adsorption, absorption...
- Intégrité du conditionnement : étanchéité, stérilité, évaporation, test in use...
- Relargage de certains composés constituant le conditionnement : étiquettes, encres...
- Dégradation forcées.
À chacune de ces problématiques, nos solutions adaptées.
Extractables / Leachables
- Une offre de prix all inclusice, sur mesure, incluant un accompagnement personnalisé de la conception de l'étude à la rédaction du rapport.
Études de stabilité
- 400 m³ de pièces et enceintes climatiques (ICH Q2, OMS, ...).
- Tous types de volumes (pièces allant jusqu'à 30m³).
- Tous types de conditionnements : imperméable, semi-perméable...
- Photostabilités selon ICH Q1B.
Posproduction: Validation of effectiveness of your intermedate & final cleaning processes.
A global solution for all your needs: from risk analysis to analytical tests.
FOCUS :
Any reusable surgical instrument or medical device has a user manual or Instruction For Use (IFU). More particularly it will describe the cleaning procedure (manual, automated, detergents used, etc.). This step is crucial, as it conditions the effectiveness of the steps planned subsequently in the IFU, i.e. the disinfection and/or sterilisation performed before contact with the patient. Our experts support you in validating the effectiveness of cleaning your instruments. Fitted with disinfecter washers, we implement your procedures on different types of organic contaminants (proteins, carbohydrates,…) in order to demonstrate their performance.
Reusables: Clenaing & disinfection of multiple use instruments.
Reusable instruments:
AAMI TIR: 12, AAMI TIR: 30, AAMI ST98, NF EN ISO 15883-1, NF EN ISO
15883-5, NF EN ISO 17664
FDA GUIDE (Reprocessing Medical Devices in Health Care Settings)
GUIDE FDA (Reprocessing Medical Devices in Health Care Settings)
Posproduction: Validation of effectiveness of your intermedate & final cleaning processes.
A global solution for all your needs: from risk analysis to analytical tests.
Reusables: Clenaing & disinfection of multiple use instruments.
Reusable instruments:
AAMI TIR: 12, AAMI TIR: 30, AAMI ST98, NF EN ISO 15883-1, NF EN ISO
15883-5, NF EN ISO 17664
FDA GUIDE (Reprocessing Medical Devices in Health Care Settings)
GUIDE FDA (Reprocessing Medical Devices in Health Care Settings)
FOCUS :
Any reusable surgical instrument or medical device has a user manual or Instruction For Use (IFU). More particularly it will describe the cleaning procedure (manual, automated, detergents used, etc.). This step is crucial, as it conditions the effectiveness of the steps planned subsequently in the IFU, i.e. the disinfection and/or sterilisation performed before contact with the patient. Our experts support you in validating the effectiveness of cleaning your instruments. Fitted with disinfecter washers, we implement your procedures on different types of organic contaminants (proteins, carbohydrates,…) in order to demonstrate their performance.
VALIDATION OF YOUR PACKAGING
ACCELERATED AGEING:
- Storage and tests performed on the same site
- Global storage volume close to 500m³
- Salles climatiques allant jusqu'à 50m³
- Multiple and customizable conditions (ASTM F1980, ICH)
- Storage areas under permanent surveillance with alarm systems: Temperature & Hygrometry
TESTS ON PACKAGING:
- Chemical analyses →
We check compliance of your raw materials (plastic, lubricants, etc.) used for manufacturing your packaging with the different Pharmacopeia. We control quality of your packaging used for the primary packing of drugs or medical devices (blisters, sachets, IV bags, plastic containers, etc.).
- Extractables / Leachables →
Analytical expertise
'All inclusive' service
Bespoke / outsourced offer
Last generation equipment
Single contact for monitoring your project
Risk analysis
Toxicological report
- Tests on packaging →
- Visual inspection:
ASTM F1886 / F1886M - Sealing tightness:
ASTM F3039 méthode A
ASTM F1929 méthode A - Sealing width:
NF EN 868-5 annexe E - Sealing force:
ASTM F88 / F88M
NF EN 868-5 Annexe D - Bubble test :
ASTM D6653 / ASTM F2096 / ASTM D3078
- Particle counting →
Biocompatibility ASTM 2475 : 2020 →
Risk analysis and validation of biocompatibility of your
primary packaging.
- Microbiological analyses →
- Sterility test
- Bioburden
- Endotoxins
- Toxicological studies
BIOLOGICAL RISKS ASSESSMENT (B.R.A):
Biological evaluation plan (BEP) :
ISO 10993-1, ISO 14971
Biological risks analysis and biological evaluation planning.
Chemical characterisation (extractables) :
NF EN ISO 10993-12, NF EN ISO 10993-18
First step for the demonstration of biocompatibility of a medical device COFRAC approved analyses.
INSOLUBLE COMPOUNDS
Search for and characterisation of insoluble particles using appropriate techniques.
Toxicological risks assessment (T.R.A):
NF EN ISO 10993-17
In-vitro test:
Cytotoxicity:
NF EN ISO 10993-5, NF EN ISO 10993-12
Enables qyick assessment of the acute toxicity of your
medical device.
Irritation :
NF EN ISO 10993-23 / NF EN ISO 10993-12
Biological evaluation report (B.E.R) :
ISO 10993-1