Testing by Product
Smither helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with our extensive independent medical device testing capabilities.
Our testing by product service includes physical, functional, and chemical testing for products such as inhalation and respiratory products, injectable devices, on-body delivery systems (OBDS), auto injector systems, oral delivery syringes, single-use technologies (SUT), transdermal and topical patches, vaginal drug delivery rings, luer fittings and connectors, ophthalmic products, as well as electronic nicotine delivery systems (ENDS) and e-cigarettes.
E-Cigarettes
Testing services for electronic nicotine delivery systems (ENDS) and e-cigarettes covering aerosol chemistry, nicotine delivery, device performance, and regulatory compliance for FDA and global markets.
Implantables
Comprehensive biocompatibility, mechanical, and chemical testing for implantable medical devices — supporting ISO 10993 biological evaluation, fatigue testing, corrosion resistance, and long-term implant performance.
Inhalation and Respiratory Products
Physical, functional, and chemical testing for inhalers, nebulisers, spacers, and respiratory devices — covering aerodynamic particle size distribution, dose uniformity, leak testing, and device performance to ISO and FDA standards.
Large Volume Parenterals
Testing for large volume parenteral drug products and their container closure systems — covering extractables and leachables, particulate matter, container integrity, and sterility assurance.
Ophthalmic Products
Specialised testing for ophthalmic drug delivery devices including contact lenses, eye drops, and ocular implants — covering biocompatibility, extractables, optical performance, and packaging integrity.
Injectable Devices
Performance and safety testing for auto-injectors, prefilled syringes, wearable injectors, and needle systems — covering dose accuracy, glide force, needle penetration, extractables, and ISO 11608 compliance.
Single Use Technologies and Processing Equipment
Extractables and leachables, biocompatibility, and performance testing for single-use bioprocessing systems — including bags, tubing, filters, and connectors used in biopharmaceutical manufacturing.
Transdermal / Topical
Testing for transdermal patches and topical drug delivery systems — covering adhesion, drug release, skin permeation, extractables, and packaging compatibility to FDA and EMA guidelines.
Vaginal Drug Delivery
Physical, chemical, and functional testing for vaginal drug delivery rings, pessaries, and intravaginal devices — supporting design verification, biocompatibility, and regulatory submission.
Luer Fittings & Connectors Testing & ISO 80369
Dimensional, functional, and performance testing of luer fittings, connectors, and small-bore connectors to ISO 80369 series — supporting misconnection prevention and regulatory compliance.
On-Body Delivery Systems (OBDS)
Testing and evaluation of on-body delivery systems including wearable injectors and patch pumps — covering mechanical performance, drug compatibility, extractables, and human factors assessment.
Oral Delivery Syringes
Functional and dimensional testing of oral delivery syringes — covering dose accuracy, tip cap integrity, leachables, and ISO 11608 and USP compliance for paediatric and adult liquid medications.