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SteriPure-P-Datasheet

Features

• Strong chemical compatibility
• High flux, low protein binding
• Proven sterilizing-grade filter cartridge
• Super long service life

Applications

• Sterilizing filtration of water for injection, cleaning solutions, purified water, deionized water
• Sterilizing filtration of LVP, APIs, buffers, eye drops, disinfectants, etc.
• Sterilizing filtration of vaccines, serums, biological products, antibiotic water-based liquid, etc.
• Filtration of red wine, beer, juice, purified water
• Sterilizing filtration of dairy products

Technical Parameters

FAQ

1. You have multiple PES filter series (SP, SPB, SPP, SPD, SPH). It's a bit confusing. Can you explain the difference in the simplest way?

Absolutely. We designed these series to address specific core application challenges. When choosing, just ask yourself two key questions: 1. What is my primary goal ? (Sterilization, Clarification, Pre-filtration ?) 2. What is my biggest challenge? (Clogging, Product Adsorption, High Flow Rate, Critical Safety?). The answers will point directly to the most suitable MS series products.

2. I'm in the food & beverage industry, frequently filtering turbid liquids like juices and syrups. The filters clog too fast. Any solution?

Yes, this is exactly the pain point our SPH Series (High Loading Capacity) addresses. Its core feature is an exceptionally high dirt-holding capacity—like having a "large reservoir"—that traps and holds more impurities. This significantly extends the service life of a single cartridge in turbid liquids, reducing your change-out frequency and downtime. It's the ideal choice for maximizing production efficiency and cost-effectiveness.

3. I need a sterilizing-grade filter for high-value bioprocesses. Both SPB and SPP are sterilizing grade. Which one should I choose?

It depends on your process's  primary optimization goal:

1) If you prioritize "Faster Filtration & Higher Yield": Choose the SPB Series (High Flow Rate). It slightly reduces dirt-holding capacity in exchange for ultimate flow speed and minimal product adsorption. It's perfect for relatively clean fluids where maximizing throughput and recovery is critical.

2) If you prioritize "More Stable & Durable": Choose the SPP Series (Long Life). It maintains sterilizing-grade assurance while featuring a reinforced construction for greater capacity and longer life. It's suited for processes requiring high stability or for fluids with moderate challenge levels in continuous operations.

4. For sterilizing-grade filtration, what are the advantages of the SPD Series compared to others?

The SPD Series offers dual advantages: The broad chemical compatibility of PES material, and Unmatched safety from its redundant double-layer design. It not only performs efficient size-exclusion bacterial retention but also withstands subsequent harsh CIP/SIP conditions, extending its service life. This dual-protection mechanism provides more reliable data support and risk control for this critical quality attribute (CQA).

5. What is the service life of the filter? How do I know when to replace it?

Service life depends on the contaminant load of the fluid and operating pressure. It is typically indicated by monitoring differential pressure (a significant increase in ΔP) or a drop in flow rate.

6. We need to perform Bacterial Retention Testing. Can you provide support?

Yes. We offer comprehensive validation services for our sterilizing-grade filters. We can provide third-party validation reports for standard bacterial challenge tests (e.g., using Brevundimonas diminuta per ASTM F838). Furthermore, we can assist in designing a Product-Specific Bacterial Retention Validation protocol to meet FDA and EMA guidelines.

7. Are Extractables and Leachables (E&L) study data complete for your filters?

Yes, they are comprehensive. For our sterilizing-grade PES series, we have conducted thorough extractables studies under rigorous lab conditions using multiple model solvents (e.g., water, ethanol, acid, alkali). Studies employ high-sensitivity instrumentation (GC-MS, LC-MS, ICP-MS) to identify and quantify extractables. Complete extractables reports are available for regulatory filings. For leachables studies, which are highly product/process-specific, we can provide experimental design guidance and collaborative testing support.

8. My filtration process faces challenges (e.g., complex fluid composition, extremely high risk). The SPD Series sounds advanced. Is it necessary?

The SPD Series is your "strategic reserve" for process safety. Its dual-layer precision PES membrane structure provides physical redundancy. If the first layer faces an extreme challenge, the second layer ensures absolute security. It's more than a product; it's a risk mitigation strategy, especially for critical points with stringent regulatory demands or extremely high batch value (e.g., virus clearance, final product sterilization), adding a "double insurance" to your quality and compliance.

9. The SP Series seems like a basic model. When is it most appropriate to use?

The SP Series is a highly cost-effective "guardian" in your filtration train. It's ideal for non-sterile final process steps, where its primary task is to significantly reduce microbial and particulate load. This effectively protects downstream, more critical filtration units (like sterilizing-grade filters) or expensive equipment. Using the SP series in pre-filtration/clarification steps optimizes the cost-effectiveness of your entire filtration process.

10. Do all these series support integrity testing?

Yes. Our sterilizing-grade filters (SPB, SPP, SPD) are 100% integrity tested before shipment with certificates provided, fully supporting standard test methods (Diffusive Flow, Bubble Point, Water Intrusion).

11. Can we get samples for testing first?

Highly recommended! Actual testing is the best way to verify suitability. Please contact our sales or technical support with your **process fluid samples and parameters. We will recommend the most suitable series and provide test samples to help you make the best data-driven decision.

12. How can I get a quote and what is the lead time?

Please provide the series, pore size, dimensions, and annual estimated volume you are interested in. We will promptly provide a competitive quotation. Our supply is stable and flexible. Standard products are often in stock, ensuring quick delivery.

13. How is after-sales service and technical support guaranteed?

We provide a dual guarantee of "Product + Service": Product: All cartridges undergo 100% integrity testing before leaving the factory and are backed by a warranty. Service: Our team of professional application engineers offers complimentary initial selection guidance, SOP training for cartridge replacement, and integrity testing method consultation. For any issues that arise, we guarantee a response within 24 hours and will provide a resolution.

14. Compared to competitors, how do you ensure consistency in your filters?

We utilize fully automated production lines to ensure absolute consistency in pleating and welding for every cartridge. Strict quality control is maintained through a batch traceability system (each filter has a unique serial number).

15. Are there volume discounts or benefits for long-term partnerships?

Yes! We offer tiered pricing for large-volume orders, long-term contracts, and annual procurement plans. Framework agreements can be established to lock in prices and ensure supply chain stability.