With single-use technologies advancing at a rapid rate, the biopharmaceutical production industry has seen an increase in FDA-issued mandates that require manufacturers to demonstrate the safety of materials. It’s important to test and analyze any potentially hazardous chemicals that derive from exposure to extreme conditions or any elements that a material could encounter. Leachables and extractables testing ensure the safety of every aspect of the biopharmaceutical manufacturing process to monitor and restrict human exposure levels. 

 

What are extractables?

Extractables are organic or inorganic substances that can be pulled out of, or extracted from the components of fully disposable single-use systems under extreme conditions. Examples of extractables-tested processing devices or systems include single-use bioreactors, membranes, tubing, sensor housing, containment bags, connectors and disconnectors. By carefully regulating and controlling laboratory testing conditions, the identification of extractables enables early risk assessment, assists in material selection and assures quality bioprocess manufacturing. 

 

What are leachables?

Leachables are organic or inorganic substances that come out of, or leach from the components of fully disposable single-use systems under normal application, packaging or storage conditions. Though leachables are primarily subsets of extractables, secondary leachables are chemical components that result from interaction with the product or packaging itself, such as ink or adhesives. 

 

Testing Practices

Extractables are typically identified in single-use disposable technology through a series of tests involving elevated heat, high pressure, and multiple sterilization cycles to evaluate worst-case scenarios. Any compounds released during this process are characterized, evaluated and examined per FDA guidelines to identify potential leachables and hazards.  

The identification of leachables in single-use technologies often occurs during extractables testing as the extreme conditions may provoke the migration of materials. However, secondary leachables sometimes require complex testing over long periods to simulate the products’ shelf life. Additionally, leachables can be found in the final product, and trace levels are monitored and reported for assessment. 

 

Solvay Specialty Polymers

Solvay’s broad portfolio of medical grade specialty polymers meets and exceeds the industry demands for higher performing plastics in biopharmaceuticals. Udel® PSU (polysulfone), Veradel® PESU (polyethersulfone), Radel® PPSU (polyphenylsulfone), KetaSpire® PEEK (polyetheretherketone), Ixef® PARA (polyarylamide), Solef® PVDF (polyvinylidene fluoride) offer increased productivity and reduced energy consumption for a wide range of biopharmaceutical processing materials. All of our specialty polymers are tested and evaluated under USP Class VI testing standards, both before and after gamma irradiation. Solvay follows BPSA-BPOG leachable and extractable test protocols to facilitate the confident recommendation of our materials for biopharma processing applications. 

Learn how Solvay specialty polymers help meet the needs of biopharmaceutical single-use technology.