Smithers Medical Device and Pharmaceutical Product Testing
Smithers provides testing services for medical devices and pharmaceutical products to demonstrate compliance to regulatory guidance or specifications set out by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the United States Pharmacopoeia (USP), the American Society for Testing and Materials (ASTM) and the International Organization for Standardization (ISO).
The company offers a wide range of tests, including pharmaceutical and medical device chemical analysis, drug delivery device and accessories testing, as well as healthcare product and packaging validation, support demonstrating regulatory compliance, materials selection and characterisation.
Testing solutions in compliance with international standards
Smithers’ experienced team provides expert guidance on polymer and packaging materials to support clients in meeting design specifications. Its laboratories provide evidence that material properties, active pharmaceutical ingredient (API) compatibility, physical stability through processing and sterilisation, transit and shelf life are fully understood.
The company works in compliance with international standards, routinely developing and validating product test methods. It is also able to provide independent measurement and assessment of qualification and routine batch conformance.
Smithers’ laboratories are accredited by the United Kingdom Accreditation Service (UKAS) to ISO 17025 and the firm is a member of the International Safe Transit Association (ISTA) and the Bioprocessing Systems Alliance (BPSA).
In addition, Smithers is also able to work with clients to provide work to good manufacturing practice (cGMP) principles.
Pharmaceutical and medical device chemical analysis
Smithers’ expertise encompasses medical devices and primary container closure systems such as metered dose inhalers (MDI) and prefilled syringes, as well as secondary packaging components and single-use processing systems such as bioprocessing bags.
The firm’s expert testing and analytical services for medical and pharmaceutical applications include:
- Extractables and leachables (E&L)
- Single-use systems (SUS) and medical devices
- Chemical properties
- Compounds, base polymers, additives and adhesives
- Pharmacopoeia packaging materials
Drug delivery device and accessories physical and functional testing
Smithers provides standard and non-standard testing (ISO, ASTM or Pharmacopeia) on a wide range of drug delivery devices, accessories and packaging to ensure that the product is safe and fit for use.
As an independent testing laboratory, the company has extensive experience supporting clients with verification testing and processes and will work with clients to provide work to cGMP principles. Its experts also develop and validate custom tests used to support regulatory submissions in the EU and the US.
Smithers’ services include:
- Product research and development (R&D)
- Performance characterisation
- Industrial standards conformity
- Device verification and validation
- Batch conformance testing
- Post-market surveillance
- Failure investigation
The types of products that Smithers has tested include:
- Needle-based injection systems (NIS)
- Pump dispensers
- Hypodermic syringes and prefilled syringes
- Small bore connectors
- Packaging for terminally sterilised MDTs
- Transfusion equipment
- Injection vials and caps
- Small bore connectors
Healthcare product and package validation
Demonstration of fitness for purpose in supply is a vital element in new product and pack development and is a mandatory regulatory requirement.
Smithers provides a range of packaging services to ensure that products are packed in such a way that their characteristics and performance during intended use will not be adversely affected during transport and storage.
The company helps clients:
- Achieve regulatory compliance
- Reduce damage
- Reduce packaging costs
- Reduce lead time to launch
- Improve design and aesthetics
Its services include:
- Product and pack validation
- Shelf-life studies
- Transport simulations
- Medical device pack integrity testing
- Pharmaceutical container closure integrity (CCI) testing
Medical device materials selection and evaluation
Smithers provides a comprehensive material selection and product design service for the medical device industry.
The company helps clients select suitable materials for a wide range of medical devices, taking into account the environmental conditions experienced during manufacturing, storage, transport and when in-use. Biocompatibility, traceability, sterilisation techniques, the impact of materials on the manufacturing environment, relevant regulation and engineering requirements are also considered in material analysis.
Its services include:
- Material selection
- Formulation development
- Compatibility assessment
- Reverse engineering
- Material sourcing and supplier qualification
- Durability testing
- Technical audit of supply chains
- Fault and failure diagnosis
- In-house training
Products and Services
425 West Market Street
Akron, OH 44303-2099
United States of America