LePure Biotech LePurseal^™ II is designed for bioprocess compliance. It features three-level user access control and one-touch login. User account management ensures records cannot be altered and support audit trails. A complete IOQ (Installation and Operational Qualification) documentation package and aseptic validation reports are also available.

Integrity testing for sterilizing-grade filtration includes destructive testing, such as bacterial retention testing performed by the supplier, and non-destructive testing performed by the user.
Common methods include the bubble point (BP) test, diffusion flow (DF) test, and water intrusion test (for hydrophobic filters).
China and the US regulataries require filter integrity testing post use. The European Union, Japan, and WHO require integrity after sterilization and also after use. South Korea and India require testing before sterilization, after sterilization, and after use.

The 0.2 µm and 0.22 µm ratings are nominal pore-size designations. Under ASTM F838, a bacterial challenge test is performed under specified conditions using Brevundimonas diminuta ATCC 19146 at a challenge level of ≥1 × 10⁷ CFU/cm² of effective filtration area, and the filtrate must remain sterile. Both 0.2 µm and 0.22 µm membrane ratings are commonly used in the industry. However, not every membrane labeled 0.2 µm or 0.22 µm is sterilizing grade. A filter can be defined as sterilizing grade only after bacterial retention has been validated and correlated with a non-destructive integrity test.

LePure Biotech LeClafine^™ depth filters use a combination of cellulose, an inorganic filter aid (diatomaceous earth), and cationic resin. Their filtration mechanism combines mechanical retention with electrostatic adsorption. They are suitable for a range of clarification applications, including turbidity reduction and clarification of fermentation harvests with or without prior centrifugation, as well as prefiltration of upstream media and process intermediates.

LePure Biotech offers a full LeClafine^™ depth filtration portfolio from process development through pilot scale to commercial manufacturing.
Minicap: 20 cm² effective filtration area for volumes below 1 L, with multiple grades spanning 20–0.05 µm for small-scale screening.
Midcap: 300 cm² effective filtration area for 2–5 L laboratory-scale fermentation broth clarification.
Procap (single-use filter capsule): Injection-molded and compatible with vertical or horizontal holders for 100–2,000 L manufacturing. Capsules can be stacked as required.
ST filter stack: Modules could be used with a stainless-steel housing and suitable for in-line steam sterilization in frequent, large-scale manufacturing at 100–2,000 L.
Capacity is determined under constant-flux operation at 100 LMH by monitoring terminal pressure and downstream turbidity. Minicap data can be scaled linearly to Procap or ST systems, with capacity expressed in L/m².