Thanks to the experience and technical expertise acquired over the years in relation to the execution of chemical, physical and microbiological analyses, LabAnalysis Life Science has expanded the range of services offered by including services dedicated to manufacturers of Medical Devices.
Among the services offered in this area, there are, for example, the design and development of chemical-physical and microbiological characterization studies and the biological evaluation of medical devices, the validation of critical processes and production sites.
Furthermore, a consultancy service is available that provides support to manufacturers in the CE marking process of Medical Devices, for each risk class (I, IIa, IIb and III), in accordance with the Medical Devices Regulation 2017/745.
ACCREDIA accredited tests
The activities are carried out in accordance with industry regulations and guidelines, such as ISO, UNI and ASTM standards, FDA and Pharmacopoeia (EP, USP) guidelines; but it is also possible to conduct studies by developing and validating internal methods. The ISO 17025 accredited tests in the field of Medical Devices, available on the ACCREDIA website, include:
In vitro cytotoxicity test, according to the UNI EN ISO 10993-5 standard
Skin irritation test using Reconstructed Human Epidermidis, in accordance with the UNI EN ISO 10993-23 standard
Semi-quantitative evaluation of semi-volatile and organovolatile organic compounds extracted from medical devices
Determination of elemental impurities in medical devices
ASTM F1886/F1886M weld integrity
Leakage in the weld by dye penetration (Dye penetration test) ASTM F1929
Resistance to breakage by internal pressurization (Creep test/Burst test) ASTM F1140/F1140M
Analytical areas for chemical-physical tests
In addition to the accredited tests, the LabAnalysis Life Science headquarters in Casanova Lonati has various analytical areas available for carrying out chemical-physical and microbiological tests both on the finished product and on the raw materials constituting the medical device. Among the various tests that can be carried out, also carrying out method validation, there are:
Bioburden, in accordance with the Pharmacopoeia and ISO 11737-1;
Sterility, in accordance with the Pharmacopoeia and ISO 11737-2;
Bacterial endotoxins (LAL test) in accordance with the Pharmacopoeia and ISO 11737-3, turbidimetric method and gel clot;
Ethylene Oxide sterilization residues (ISO 10993-7);
Production water analysis;
Routine checks for final checks for batch release, acceptance checks or in-line checks.
Furthermore, there are climatic chambers in which it is possible to conduct stability studies in accordance with the ICH guidelines (Q1A).
Additional areas of expertise
The Casanova Lonati LabAnalysis Life Science office also deals with:
Carry out biological evaluation of medical devices according to the ISO 10993 series:
ISO 10993-5: In vitro cytotoxicity test
ISO 10993-10: Skin sensitization test
ISO 10993-23: Skin irritation test using Reconstructed Human Epidermidis
ISO 10993-17 and -18: Material characterization tests (Leachable & Extractable) and thanks to the collaboration with qualified external laboratories, offers Toxicological Evaluation services of the data obtained
Biocompatibility assessments are also carried out according to specific standards for different types of medical devices, such as for example on intraocular lenses (ISO 11979-5: Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility), on systems for the administration of breathing gases (ISO 18562: Evaluation of the biocompatibility of breathing gas pathways in healthcare applications), and on thermo-disinfectors (ISO 15883-5: Performance requirements and criteria for test methods to demonstrate cleaning effectiveness).
Design and develop studies for the validation of critical processes:
Validation of the washing/cleaning process, in accordance with EU GMP and FDA guidelines
Evaluation of the effectiveness of disinfection processes
Validation of the sterilization process: dose verification, analysis of biological indicators (ISO 11138), sterility analysis
Validation of packaging (sterile barrier system) according to ISO 11607 and USP 1207 standards
Conduct performance studies on specific types of medical devices, such as:
Drug infusion devices: application of ISO 28620 and ISO 80369-7 standards
Closed System Transfer Devices (CSTDs): NIOSH performance testing
LabAnalysis Life Science also deals with the periodic validation and requalification of controlled contamination environments, clean rooms and hoods, in accordance with the ISO 14644, EN 17141 series and Annex 1 of the EU GMP guideline, and offers the possibility of carrying out analyzes such as :
Particle counting
Microbiological analysis of air and surfaces
Measurement of environmental parameters (temperature, humidity and pressure difference)
Calculation of particle class recovery time (recovery time)
Determination of the number of spare parts per hour
