Purillex TM PFA and FEP Bottles - Extractables Testing

Importance of the topic

Understanding extractables from process materials is critical to ensuring the safety, quality and regulatory compliance of biopharmaceutical products. Forced extraction studies simulate worst-case contact scenarios to validate materials for storage and transfer of high-value intermediates such as APIs and vaccines.

Goals and overview of the study

The study evaluated organic and inorganic extractables from Savillex Purillex PFA and FEP bottles under aggressive conditions. Third-party analysis over 7 and 28 days with multiple solvent systems assessed potential leachables from the fluoropolymer surfaces.

Methodology and Instrumentation

Ultraclean 250 mL PFA and FEP bottles were autoclaved, rinsed and filled with one of five extraction media: ultrapure water, pH3 citrate buffer, pH10 carbonate buffer, methanol and hexane. Three bottles per material were sampled after 7 days and three after 28 days at 70°C (water) or 35°C (other solvents).
Organic analysis employed:

• HPLC-UV/MS and LC/MS with APCI and ESI in positive and negative modes
• GC-MS and GC-FID for volatiles and semivolatiles
• Total organic carbon analyzer and conductivity meter

Inorganic analysis used:

• HR-ICP-MS and ICP-QMS instruments covering USP Chapter 232 and ICH Q3D elements

Main results and discussion

Organic techniques detected no nonvolatile, semivolatile or volatile compounds above blank levels in any extracts. TOC and conductivity measurements showed no significant changes over 28 days. Inorganic analyses revealed ultratrace metal levels. The strongest extraction (pH3 buffer) yielded under 12.5 ng total metals per bottle (under 0.78 μg/m2). Other solvents produced even lower totals. No meaningful difference was observed between PFA and FEP or between 7 and 28 day extracts. Hexane results were inconclusive due to blank contamination.

Benefits and practical applications

Purillex PFA and FEP bottles demonstrate exceptional inertness and cleanliness, supporting their use in critical biopharmaceutical workflows including API processing and vaccine storage. The data provide evidence for material selection in quality assurance and regulatory submissions.

Future trends and opportunities

Advances in trace analysis and ultraclean solvents may further refine extractable profiling. Emerging high-resolution MS and predictive surface modelling will enhance risk assessment. Development of next-generation polymer technologies may expand material options for bioprocessing.

Conclusion

Under rigorous extraction protocols, Savillex Purillex PFA and FEP bottles released no detectable organic compounds and only ultratrace inorganic species well below regulatory thresholds. These findings confirm their suitability for demanding biopharmaceutical applications.

Reference

1. Dupont Wilmington DE. 7-day and 28-day Extraction Results for Savillex PFA Bottles, January 2014.
2. Dupont Wilmington DE. 7-day and 28-day Extraction Results for Savillex FEP Bottles, January 2014.