What is Analytical Chemistry Testing?
In the context of medical device or pharmaceutical applications, analytical chemistry testing of materials often focuses on chemical compounds capable of migrating from a material either directly into the body or into a drug product. Alternatively, this term can refer to the measurement of bulk physiochemical properties. For medical device manufacturers, analytical tests ensure incoming materials are unlikely to cause biocompatibility problems later or check consistency from lot to lot.
For pharmaceutical manufacturers, additional tests conducted by an analytical laboratory may include screening active pharmaceutical ingredients (APIs) for potency, purity, and impurities; chemical analyses of pharmaceutical containers and stoppers using extractables and leachables (E&L) testing; and analysis of raw materials used in pharmaceutical production (e.g., water sources).
Why is it important to conduct Analytical Testing?
Analytical chemistry testing is a vital part of any biological safety evaluation to assess and mitigate potential toxicological risks for patients or users. For medical devices, this most often applies when devices contact the body for prolonged or permanent periods. For pharmaceuticals, the question of toxicological risk applies more generally.
In addition to patient risk, the practical consequences of a poor chemical assessment are significant, measured in lost time, excessive costs, and delays in securing regulatory approvals. Nelson Labs ensures testing is expertly tailored to address the safety issues specific to a particular product while taking into consideration the scientific and practical realities faced by clients.
What are the main types of Analytical Chemistry Testing offered by Nelson Labs?
Nelson Labs is a global leader in pharmaceutical, medical device, and tissue testing and conducts a wide range of tests to meet our customer’s needs. Some examples of the testing we provide include:
Extractables and Leachables: Extractables testing is essential in determining what compounds are present in a medical device as well as the migration of harmful organic and inorganic impurities into a pharmaceutical product. For pharmaceuticals, extractables is often followed by leachables (testing for specific extractable chemicals in a drug product using validated methods). This testing is crucial in maintaining that drug efficacy and patient safety are not compromised.
Material Characterization for Understanding CMRs: Nelson Labs offers a comprehensive set of tests for the characterization and screening of raw materials. Material screening helps manufacturers select their suppliers and routine monitoring of materials ensures delivery of a consistent product. This is especially important when evaluating the presence of CMRs (Carcinogenic, Mutagenic, or Reproductive Toxicants) and in meeting the requirements of Regulation (EU) 2017/745 “the MDR” section 10.4.2, which requires manufacturers to justify the presence of CMRs or Endocrine Disruptors (EDs) in concentrations greater than 0.1% weight-by-weight.
Routine Tests for Cleaning Validation and Supplier Change Assessment: Evaluation of the effectiveness of a medical device cleaning process used to remove residual manufacturing materials (RMM) from newly manufactured devices is a requirement of 21 CFR Part 820. Documentation of these tests along with the interpretation of results are often used as supplemental support of biocompatibility, in support of a regulatory submission, or in the event of a US FDA or notified body audit. Supplier change assessments are extremely important as they evaluate whether potential raw materials are of sufficient quality to meet the goals of the device and be released into production. This helps manufacturers select their suppliers, and with routine monitoring of materials, ensures delivery of a consistent product. A supplier change evaluation will typically involve a comparison of candidate materials with materials used in a currently cleared device to determine if a claim of equivalence can be made. These comparisons are often made with a combination of tests selected with expert guidance from the person making the evaluation:
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- FTIR: Fourier transform infrared (FTIR) analysis is a popular analytical tool for material screening. The technique works because each different type of molecular bond in a molecule vibrates differently, and there is often a set of molecular vibrations that form a characteristic “fingerprint.” When measuring a molecular substance, it is possible to identify an organic substance by comparing its FTIR spectrum to a library. This method is particularly useful as a first step in the identification of an unknown residue as well as for the assessment of material changes after a process modification.
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- NVR: Non-volatile residue (NVR) testing is performed to show how much non-volatile material is present in an extract. This test quantifies any substances in the extract which do not volatilize at or above a temperature of 105°C and is used to determine the levels of impurity in a solvent and detect contamination.
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- TOC: Total organic compound (TOC) analysis is performed to detect and verify acceptable levels of organic (carbon-containing) compounds. This testing should be conducted to ensure USP and EP standards for water quality are met, as well as when validating the cleanliness of single-use and reusable medical devices.
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- THC: Total hydrocarbon (THC) analysis quantifies the presence of hydrocarbons by using GC-FID (gas chromatography equipped with a flame ionization detector). This testing is used as part of the cleaning validation process for medical devices.
For technical expertise on your product’s testing or to speak with a member of our team, email [email protected] or call 1-800-826-2088.
