Smithers chemical analysis expertise encompasses medical devices, primary container closure systems, secondary packaging components, single use processing systems as well as excipient and API analysis:
Extractables and leachables testing
Our studies provide a means to assess the substances which migrate from drug product and patient contact materials, potentially affecting the safety or efficacy of drug products and may pose a risk to the patient’s wellbeing. Smithers’ comprehensive extractables and leachables testing programs are designed to fulfil the global regulatory requirements for container systems and materials. Our test programs follow USP, PQRI and industry best practice.
Our laboratories are ISO-17025:2005 accredited, FDA registered and inspected and operate a wide range of analytical equipment and techniques to examine the chemical properties of polymeric materials, excipients and API.
Potential Genotoxic Impurities (PGIs)
Regulatory bodies require careful assessment and strict control of potential genotoxic impurities (PGIs) that can be found in drug substances and products or introduced during the manufacturing process. At Smithers our experts have the industry knowledge and laboratory resources to develop and validate extremely precise methods and analytical procedures to help you satisfy regulatory requirements related to PGIs.
Polymer Specialist to the pharmaceutical and medical device industries, Smithers can support your medical device submission. We offer extractables studies for medical devices based on ISO 10993 and industry best practice. Our facilities support chemical analysis inclusive of extractables and leachables and degradation in support of ISO 10993.
Troubleshooting Impurities and Contamination Analysis
Smithers experts can assist you with trouble shooting a wide range of problems encountered with contamination and impurities in materials, packaging and drug products. Our first-class laboratories provide confidential, high quality data and can offer an expedited service when required.
Packaging Materials Pharmacopoeial Testing
We support European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) testing for container closure, packaging and material testing.
Single Use Technologies (SUT)
Smithers can customise testing to your needs or conduct studies following BPOG, USP and other industry standards.
Download a brochure for more information: