LABORATORY TESTS

Lab4LIFE offers a wide range of microbiological and physic-chemical tests for pharmaceutical and medical device industry:

• Bioburden test;
• Sterility test;
• LAL test;
• Challenge test according to Ph. Eur.;
• Microbiological analysis on pharmaceutical according to Ph. Eur.;
• Evaluation of efficacy for disinfectants;
• Sterilization and washing process validation;
• Stability and shelf life evaluation using accelerated aging tests with ICH climate chambers;
• Clean room validation;
• EO residuals;
• Packaging validation;
• Global and specific migrations;
• Materials characterization according to ISO 10993-18;
• Formulations for cutaneous / nasal / buccal use - In vitro permeation test in Franz cell for the evaluation of the functionality of medical devices based on substances, useful for their classification according to REGULATION (EU) 2017/745

BIOCOMPATIBILITY TESTS

In partnership with a fully compliant to GLP and ISO 17025 test facility we can offer the complete list of biocompatibility tests according to ISO 10993 standards.

• Cytotoxicity according to ISO 10993-5;
• In vitro and in vivo skin irritation according to ISO 10993-10;
• In vivo skin sensitization according to ISO 10993-10;
• Haemocompatibility tests according to ISO 10993-4;
• Subcutaneous / muscular / bone implant according to ISO 10993-6;
• Genotoxicity tests according to ISO 10993-3;
• Subchronic toxicity according to ISO 10993-11;
• Materials characterization tests according to ISO 10993-18;

CONSULTANCY

Our team has built up specific competence in the regulatory framework of medical device class I, IIa IIb; III. We can support our customers in resolving issues related to regulatory compliance and assessment of the safety and effectiveness and process.

Main consultancy services:

• Support for the design of the biological risk assessment of medical devices and the planning of the best testing strategy based on the new requirements of ISO 10993-1:2018;
• Toxicological evaluation of data obtained from chemical characterization tests of components of medical devices;
• Planning the best testing strategy for the pre-clinical assessment of medical devices for dentistry use according to ISO 7405;
• Design of Study Protocols according to ISO 10993 series;
• Design of operating protocols for sterilization process;
• Design of operating protocols for washing process;
• Design of Scientific rationale for the biocompatibility assessment of medical devices;
• Evaluation of toxicological data to support product efficacy and safety;