Chemical – Micro – Physical MD Testing

Besides In Vitro Testing, other testing is also necessary for the safety of Medical Devices. Laboratory Testing services for the Chemical examination and the evaluation of Mechanical Properties is necessary for manufacturers to evaluate hazard potential and product safety.

What can you achieve with Physicochemical MD testing?

  • Identify potential chemicals migration to the Medical Device & Determine their impact on human health
  • Determine environmental effects and establish product storage and expiry date criteria
  • Test strength, brake load and other physical characteristics of Medical Devices
  • Evaluate microbiological safety by examining the presence of harmful pathogens

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 medical device testing 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

Medical device testing includes 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.

Medical Devices Testing