Single-Use Systems - Extractables and Leachables Testing
While single-use systems offer many benefits to biopharmaceutical manufacturers, such as increased efficiency, processing flexibility and reduced cleaning validation time, they do also present issues around extractables and leachables.
Although, currently, no regulations around extractables and leachables exist for single-use systems, suppliers of these and manufacturers incorporating them into processing lines must ensure that they are able to assess the associated risks, design a leachables study and detect, identify and quantify leachables through appropriate analytical methods.
At Lucideon we can help you to do this.
Single-use Systems Risk Assessment
Our experts will assess risks associated with single-use systems in your processing line, considering the following:
- Pre-treatment steps
- Solutions - properties and volumes
- Temperatures - scale and length of contact
- Process stream.
This assessment will determine those single-use systems applications that require further leachables analysis.
Single-use Systems Study Design
As no regulations currently exist, we can help you to put together a methodology that will thoroughly analyse extractables and leachables. We can advise on sample collection and handling, the appropriate solvent for testing, how long the analysis should be carried out for, and the contact time and temperature parameters.
Single-use Systems Extractables and Leachables Testing
Extractables and leachables need to be detected, identified and quantified. At Lucideon, using our state-of-the-art analytical capabilities, we can work alongside you to help you to do this, thereby providing accurate and robust data for quality control and regulatory purposes.
Our Analytical Techniques Include:
- GC-MS (including headspace)
- Gravimetric analysis.