Medical device testing should ensure safety for all medical devices. Biological, in vitro, chemical, microbiological, stability and physical medical device analysis is offered.
Biological testing includes:
- Cytotoxicity of Medical devices
- Sensitization of Medical devices
- Irritation or intracutaneous reactivity of Medical devices
- Systemic toxicity of Medical devices
- Subchronic toxicity of Medical devices
- Genotoxicity of Medical devices
In the field of in vitro testing, QACS Lab conducts medical device testing, based on reconstructed human tissue.
- We offer standard skin and eye irritation tests.
- We also carry out in vitro irritation studies on final products or raw materials that come into contact with various mucous membranes, such as:
-Oral cavity (oral or gingival tissue viability for oral products)
-Human airway (nasal and inhalable products)
-Female intimate area (vaginal epithelial tissue for intimate area products)
We offer a wide range of physicochemical and analytical services on starting materials and finished products.
The tests we conduct include:
- Chemical analysis and assays
- Method development, validation and identification
- Quantification of degradation products
- Extractables and leachables studies
- Testing for traces and impurities
All the tests may be included in stability protocols.
Our premises consist of state-of-the-art instruments and equipment, including LC-MS/MS, HPLC, GC, GC-MS, ICP-MS and AAS.
Laboratory medical device testing services concerns product testing during product development for preservation adequacy against microbial contamination.
Laboratory testing services include:
- Microbial enumeration of raw materials and finished products
- Challenge tests (based on both the European and US Pharmacopoeia reference standards)
- Validation protocols and reports
Tests can be included in stability protocols.
Environmental factors such as temperature, humidity & light affect medical studies, therefore stability studies for medical devices should be conducted. Testing evidence services ensure stability and quality of the product to be evaluated.
To document the shelf life of medical devices, we conduct stability studies that include different storage conditions of temperature and humidity (both ICH and non-ICH conditions). The devices are tested at regular intervals.
We also offer ICH photostability testing to support:
- Product photostability
- Container compatibility
- Packaging materials and labels
We offer a wide range of services to test strength, brake load or even the inhaler performance of a device or its container.
Tests we conduct include:
- Extrusion force of pureed products
- Hardness and strength testing
- Film integrity for seals and packaging
- Cake strength
- Spread force
- Evaluation of inhaler performance