When people hear we are a laboratory, we often get asked, “Do you test on animals?”. The simple answer is no, we do not. Respiratory Protective Equipment (RPE), including masks and filters, are tested using mechanical, physical, and human subject methods, not animal testing.
Our testing focuses on aspects such as:
- Filtration efficiency (using aerosols like NaCl or paraffin oil).
- Uses lab-based aerosol measurement.
- Inward leakage which measures how efficient the respirator is at keeping out airborne hazards.
- Tested on human test subjects wearing the RPE.
- Breathing resistance, how difficult it might be to breathe whilst wearing a respirator.
- Machine tested with flowmeters or breathing simulators with dummy head forms.
- Flammability and flame engulfment.
- Involving flame exposure under controlled laboratory conditions.
- Mechanical strength of hoses, connectors and harnesses.
- Using tensile test rigs and dead weights.
- Fit, usability and comfort which we call Practical performance testing.
- Carried out on human test subjects to simulate working conditions.
Most respirator performance standards (e.g. EN 149, EN 12941, EN 137) require some tests that simulate human breathing or use human test subjects, but do not involve animal exposure.
The materials used in respirators, (particularly where they are in contact with the user’s face, or in the air-flow path) such as nonwoven polypropylene, activated carbon, plastics, rubbers or elastomers, are generally tested by the manufacturer for:
- Biocompatibility:
- The ability of a material to perform with an appropriate host response in a specific application. Ensuring a material is biocompatible means it will not cause unacceptable harm or adverse reactions when placed in contact with the body.
- Cytotoxicity:
- The quality of being toxic to cells. Assessing cytotoxicity is fundamental for evaluating the safety and efficacy of compounds, chemicals, and materials, as it helps predict potential adverse effects.
- Skin irritation:
- Skin irritation testing is a critical step in evaluating the safety of products that come into contact with human skin. It helps to identify substances that can cause inflammation or damage to the skin upon contact.
Historically, some of these tests used animals; however, there is a growing transition toward in vitro methods and computational modelling, driven by compliance with EU legislation and REACH’s mandate to reduce animal testing wherever scientifically possible.
According to EU PPE Regulation 2016/425, materials must be evaluated, appropriate testing conducted and presented as part of the CE certification process. Ethical standards in the EU and many other regions discourage animal testing when validated alternatives exist.
NB: all the tests on Human volunteers are conducted under strict controls and using inert and non-dangerous substances. Furthermore, the manufacturer submitting the products for testing, MUST have already conducted testing on the materials to ensure that they are safe for us to handle and for our test subjects to wear.