Raw materials for medical devices

Determination of breathability (differential pressure) on surgical masks

Regulatory reference:	UNI EN 14683:2019.
Claim:	Determination of breathability
Application field:	Raw materials and finished products.
Description of the test:	Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Determination of breathability, Claim for medical devices

In vitro skin irritation test according to ISO 10993-23:2021

Regulatory reference:	ISO 10993-23:2021.
Claim:	Biocompatible
Application field:	Raw materials and finished products.
Description of the test:	In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices, Biocompatible

Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019

Regulatory reference:	UNI EN ISO 11737-1:2018 and UNI EN 14683:2019.
Claim:	Determination of bacterial charge
Application field:	Raw materials and finished products.
Description of the test:	The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Determination of bacterial charge, Claim for medical devices

Bacterial Filtration Efficacy (BFE) testing according to ISO 14683

Regulatory reference:	ISO 14683:2019 (B).
Claim:	BFE (Bacterial Filtration Efficiency)
Application field:	Raw materials and finished products.
Description of the test:	Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, BFE (Bacterial Filtration Efficiency), Claim for medical devices

LAL (Lysate of Limulus Amaebocytes) test

Regulatory reference:	USP85.
Claim:	Absence of bacterial endotoxins
Application field:	Medical devices: raw ingredients and finished products.
Description of the test:	Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins.

Posted in Raw materials for medical devices, Absence of bacterial endotoxins, Claim for medical devices

H295R Steroidogenesis Assay – OECD 456

Regulatory reference:	According to OECD 456.
Claim:	No endocrine disruption
Application field:	Raw ingredients and finished products.
Description of the test:	The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production.

Posted in Cosmetic raw materials, Raw materials for medical devices, No endocrine disruption, Claim for cosmetics, Claim for medical devices

Mucoadhesion test

Regulatory reference:	Proprietary method
Claim:	Mucoadhesive effect
Application field:	Finished products for direct application on external mucosae.
Description of the test:	Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control.

Posted in Mucoadhesive products, Raw materials for medical devices, Surgical devices and medications, Mucoadhesive effect, Claim for medical devices

Mucoadhesion test: gravimetric variant using the dry weight of the product

Regulatory reference:	Proprietary method
Claim:	Mucoadhesive effect
Application field:	Finished products for direct application on external mucosae.
Description of the test:	Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin.

Posted in Mucoadhesive products, Raw materials for medical devices, Surgical devices and medications, Mucoadhesive effect, Claim for medical devices

Quantification of trace substances and impurities

Regulatory reference:	UE Regulation
Claim:	Titer of substances
Application field:	Cosmetics and medical devices.
Description of the test:	Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.

Posted in Filter devices, shielding films and plasters, Cosmetic raw materials, Raw materials for medical devices, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances

Quantification of the titer of substances

Regulatory reference:	Regulation 1223/209
Claim:	Titer of substances and Limit of preservatives
Application field:	Preservatives, dyes, sunscreen filters.
Description of the test:	Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

Posted in Heating and cooling products, Mucoadhesive products, Cosmetic raw materials, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances, Limit of preservatives