Turn-key solutions for medical products:

We provide devices and installations for tests of respirator masks [more], protective gloves and inhalation systems.
Among others, the following tests and measurements are carried out:

• Breathing resistance test of respirator half masks class FFP1-FFP3 acc. to EN 149 [more]
• Designation of breathability at medical face masks acc. to EN 14683 [more]
• Determining the degree of separation at medical face masks acc. to EN 149 [more]
• Testing of inward leakage at medical face masks acc. to EN 149 [more]
• Testing the carbon dioxid content of the inhalation air at medical face masks acc. to EN 149 [more]
• Leakage tests at medical gloves acc. to EN 455-1
• Dynamic flow development under different inhalation conditions
• Pressure conditions at the inhalation system
• Particle distribution for powder inhalators
• Degree of active ingredient removal for powder inhalators
• Continuity tests for long time removals
• Opening and operation force or momentum

Special considerations for building testing installations for medical products:
All parts that come into contact with the test piece are made from stainless steel. For the assembly of the testing appliance mainly eloxed aluminum, stainless steel and plastic are used.
Surface protection is selected according to the clean room category at the intended operation location.

Due to our experiences in carrying out projects in medical technology, a project can be carried out according to GAMP regulations with

• User Requirement Specification (URS),
• Design Specification (FDS/SDS),
• Design Qualification (DQ),
• Factory Acceptance Test (FAT),
• Installation Qualification (IQ) und
• Operational Qualification (OQ)

resp. the execution according to GAMP supported by us.

Measures for data protection using Electronic Records / Electronic Signature according to 21 CFR Part 11 can also be integrated if required.

Of course we also carry out projects in the area of leakage and flow testing, e.g. on medical tube systems taking into consideration the special requirements of medical technology.