Key takeaways for pharmacists, PharmD teams, 503A pharmacies, and 503B outsourcing facilities

• Use a 0.2 µm hydrophobic PTFE liquid sterilizing filter as the preferred IFP starting point for oil-based testosterone filtration.
• Do not select by pore size alone. Confirm the complete formulation, chemical compatibility, device construction, effective filtration area, pressure, temperature, recovery, and integrity-test method.
• For an approximately 500 mL oil batch, IFP recommends evaluating the D65 1.0/0.2 µm dual-layer PTFE disc first when viscosity and membrane area are the main concerns. Evaluate a dual-layer PTFE device when comparative testing demonstrates meaningful particulate loading.
• Treat IFP’s published oil-volume ranges as starting ranges for qualification, not guaranteed batch capacities.
• A passing post-use integrity test supports filter integrity; it does not replace product- and process-specific validation where validation is required. Read more >