Medical device

LabAnalysis has acquired significant experience and technical expertise in the field of chemical, physical and microbiological analysis. Today, the implementation of services dedicated to Medical Device manufacturers, has allowed to expand the scope of action, implementing activities such as the design and development of chemical-physical and microbiological characterisation studies and subsequent biological evaluation of medical devices, validation of critical processes and production sites. 

In addition, a consultancy service is available to support manufacturers in the CE marking process of Medical Devices, for each risk class (I, IIa, IIb and III), according to the Medical Devices Regulation 2017/745.

Activities are performed in accordance with industry standards and guidelines, such as ISO, UNI and ASTM standards, FDA guidelines and Pharmacopoeia (EP, USP).
Studies can be conducted by developing and validating in-house methods.

ISO 17025 accredited tests in the field of Medical Devices, available at the ACCREDIA website, include:

• In vitro cytotoxicity test, according to standard UNI EN ISO 10993-5
• 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
• Integrity of welds ASTM F1886/F1886M
• Loss on soldering by dye penetration test ASTM F1929
• Resistance to fracture by internal pressurisation (Creep test/Burst test) ASTM F1140/F1140M

In addition to the accredited tests, the LabAnalysis facility in Casanova Lonati (PV), has several analytical areas available for performing chemical-physical and microbiological tests, both on finished products and on raw materials that make up the medical device. In addition, there are climatic chambers where stability studies can be conducted in accordance with ICH guidelines (Q1A).
Among the different tests that can be carried out, including method validation, are: 

• Bioburden, according to Pharmacopoeia and ISO 11737-1
• Sterility, according to Pharmacopoeia and ISO 11737-2
• Bacterial endotoxins (LAL test) according to Pharmacopoeia, turbidimetric method and gel clot
• Ethylene Oxide sterilisation residues (ISO 10993-7)
• Production water analysis
• Routine checks for final batch release, acceptance checks or in-line checks

Additional services are provided, including 

Performing biological evaluation of medical devices according to ISO 10993 series:

• ISO 10993-5: In vitro cytotoxicity testing;
• ISO 10993-10: Skin sensitisation test;
• ISO 10993-23: Skin irritation test using Reconstructed Human Epidermidis;
• ISO 10993-17 and -18: Material characterisation tests (Leachable & Extractable) and through collaboration with qualified external laboratories, offers Toxicological Data Evaluation services

Biocompatibility assessments are also performed according to specific standards for different types of medical devices, e.g. on intraocular lenses (ISO 11979-5: Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility), on respirable gas delivery systems (ISO 18562: Evaluation of the biocompatibility of respirable gas pathways in healthcare applications), and on thermal disinfectors (ISO 15883-5: Performance requirements and criteria for test methods to demonstrate cleaning effectiveness).

Designing and developing studies for the validation of critical processes:

• Validation of the washing/cleaning process, according to EU GMP and FDA guidelines;
• Validation of the effectiveness of disinfection processes;
• Validation of the sterilisation process: dose verification, analysis of biological indicators (ISO 11138), sterility analysis;
• Validation of packaging (sterile barrier system) according to ISO 11607 and USP 1207. 

Conducting 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 also deals with the validation and periodic re-qualification of controlled contamination environments, clean rooms and fume hoods, according to ISO 14644, EN 17141 and Annex 1 of the EU GMP guideline, and offers the possibility to perform analyses 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
• Determination of number of changes per hour
• Smoke test