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Faq

Q1. What kind of company is Lizhi industry?

Lizhi industr focuses on downstream biopharmaceutical separation, purification and fluid management, following a "hardware + software dual-drive" philosophy. While we have system integration capabilities, we emphasize in-house R&D and manufacturing of core fluid components — precision diaphragm pumps, block valves, and manifold valve assemblies are all developed and manufactured in-house, and can be customized to process requirements rather than being limited to off-the-shelf standard products. On the software side, our proprietary automation platform integrates AI agents for parameter recommendation, process optimization, and fault prediction.

Hardware defines the process ceiling; software helps you approach it.
Downstream purification customers care most about four things: product yield, flux, microbial control, and concentration factor. Block valves and manifolds reduce system dead volume from the flow path design — maximizing product recovery and minimizing microbial growth areas. Diaphragm pumps deliver stable, low-pulsation flow that remains consistent even as backpressure rises, sustaining high throughput and supporting high-concentration operation. Because these components are all developed in-house, equipment design can optimize pumps, valves and piping as an integrated system — achieving deep component-to-process matching. AI agents automatically recommend parameters, predict failures, and continuously optimize curves — reducing manual tuning and strengthening batch-to-batch consistency.
This "in-house core components + AI-empowered software" model delivers not only cost advantages but also design fit and delivery certainty — components deeply matched to your process, controllable lead times, and better cost efficiency. We continuously optimize both hardware and software to help customers keep improving on key process metrics, as a partner that truly understands your process and responds quickly.


Q2. Where are your factories located?

Our headquarters is in Shanghai, China, with our main production base in Suzhou. The facility includes:
  • CNC machining centers for precision machining of valve bodies and pump heads in 316L (1.4404) / 1.4435 stainless steel

  • Class 10,000 cleanroom for production of polymer material products

  • Intelligent warehouse with RFID tag management — automatic material identification, precise location, batch traceability, and FIFO support

  • In-house surface treatment (electropolishing) and passivation lines

  • System assembly and testing workshop for complete assembly, piping connection and integrated testing of UF/DF and other purification systems

  • Comprehensive testing lab: flow calibration bench, pressure test bench, surface roughness measurement, and material analysis tools

  • FAT (Factory Acceptance Test) area supporting on-site or remote video witness testing

We welcome customer factory visits and support remote video FAT. If you are sourcing from China and would like to inspect quality before shipment, we can arrange an on-site visit or live video factory tour.


Q3. What certifications does Lizhi industry hold?

Quality and regulatory compliance are the foundation of everything we do. Our products and manufacturing systems hold the following certifications:

Certification
Scope
Description
ISO 9001Quality management system/
USP Class VIWetted polymer materialsWetted polymer materials comply with USP <87> and USP <88> testing
FDA 21 CFR 177Food contact material complianceAll elastomer and plastic wetted parts comply with FDA food contact regulations
BPOGSingle-use system compatibilityExtractables and compatibility verified per BPOG vendor consistency test 
USP <788>Tubing particulate controlTubing products pass USP <788> injectable insoluble particulate testing
EN 10204 3.1Material traceabilityEach wetted metal component (valve body, pump head) carries a heat number, with mill certificate available
ASME BPEDesign standard alignmentValves, piping geometry, surface finish, and dead leg design follow ASME BPE guidelines
In addition to the above certificates, we can also support customer audits and third-party inspection requirements (SGS, BV, TÜV, etc.).


Q4. Which industries do you serve?

Our primary market is the biopharmaceutical industry. If your application involves clean fluid handling, sanitary connections, or strict hygienic design requirements, our engineering team can assess product suitability.


Q5. What are your main product categories?

Our product portfolio spans eight categories, covering everything from individual fluid control components to complete process systems:

Product LineBrandMain ProductsTypical Applications
UF/DF SystemsExods®

Manual cassette / hollow fiber UF systems,

 fully automatic intelligent UF systems, fully automatic UF systems

UF/DF concentration, diafiltration, buffer exchange — from R&D to clinical and commercial scale
Precision Diaphragm PumpsXAccurflow®Four-Diaphragm PumpUF/DF feed pumps, chromatography feed, buffer transfer, high-precision dosing
Peristaltic PumpsXpanflow®Sanitary peristaltic pumps, variable speed, touchscreen controlSingle-use transfer, sampling, low-shear fluid handling
Diaphragm ValvesXmate Valve2-way, T-type, tank-bottom, block valve ,     needle sampling valveProcess piping, water systems, CIP/SIP circuits, vessel connections, sampling points
Automated Filling SystemsExoduc®Fully automatic intelligent filling systemsAseptic filling, finished product filling
Custom Systems—Fully automatic degradation systems, fully automatic online solid-liquid separation and collection systemsCustomized solutions for specific process requirements
Tubing & ComponentsExospure®/ArcXpure®/Xdspure®/Exodc®EPS transfer tubing, EPT abrasion-resistant tubing, Tubing Modules, manifolds, diaphragms, gaskets, Tri-Clamp fittings, Y/T/L fittings,  End cap, clampsFluid transfer, piping connections, sealing consumables
Quick ConnectorsXezconnector®Quick connectorsSingle-use system connections, aseptic transfer

Our model is component-centric: we design and manufacture core fluid control components (valves, pumps, fittings) in-house, controlling quality and cost at the source. We then integrate these components into skid-mounted systems to deliver turnkey solutions to our customers.


Q6.What is the difference between 1.4404 and 1.4435? Why does it matter?

Both are 316L-grade austenitic stainless steels; the key difference lies in the tightness of chemical composition controls:

• 1.4404 (316L): carbon content ≤0.03%, standard low-carbon stainless steel

• 1.4435 (316L improved): carbon content also ≤0.03%, but with tighter control on nitrogen content, lower ferrite content, and more uniform metallurgical structure

Why does it matter? After long-term operation in purified water / WFI systems, stainless steel surfaces gradually develop red rust (iron ions released as the chromium oxide passive layer breaks down). 1.4435, with its lower ferrite content and more uniform microstructure, exhibits slower red rust formation and more stable surface condition over long-term operation. For biopharmaceutical water systems and high-purity process fluids, 1.4435 is the preferred material.

Additionally, Lizhi industry valve bodies and pump heads use forged construction rather than cast — forged microstructure is denser with fewer inclusions, further improving corrosion resistance and long-term reliability.


Q7. Do you offer custom or OEM solutions?

Yes. In fact, a significant portion of our business comes from custom configurations and OEM partnerships with system integrators. Our in-house engineering and machining capabilities mean we are not limited to a fixed catalog — we can tailor products to your specific requirements.

Typical custom requirements include:

• Valve body modifications: special port positions, extended body lengths, custom connections (butt-weld ends, flanges, IDF), non-standard bore sizes

• Block valve (manifold) design: multi-port valve blocks machined from a single bar, optimized for your skid P&ID. We can integrate 3, 4, 5 or more valve stations into one block — reducing welds, lowering leak risk, and saving skid footprint

• Pump package customization: special motor options (ATEX, IE3, food-grade waterproof), special pump head materials, special diaphragm compounds for corrosive fluids, integrated control panels per your HMI specs

• OEM branding: for system integrators and distributors, we can provide valves and pumps with your brand identity (laser-etched logo, custom nameplates, packaging with your artwork)

• Documentation customization: customer-specific document packages (your SOP formats, your drawing numbering system, your approval stamps)

To start a custom inquiry, please share your P&ID, dimensional sketch, or performance specifications. Our engineering team will review and propose a solution, including pricing and estimated lead time, within 3–5 business days.


Q8. What is the lead time for custom orders?

Lead times vary by product category and degree of customization:

Product TypeStandard Lead TimeNotes
Catalog valves (stock configuration)2–4 weeksEx works Shanghai
Custom valve configurations (non-standard connections, special sizes)4–8 weeksRequires forged bar stock machining
Custom block valves (manifolds)6–8 weeksEngineering review + machining + assembly + testing
XAccurflow pumps (standard models)3–5 weeksIncludes factory flow calibration and test report
Custom pump packages (special materials, motors, controls)6–10 weeksDepends on special component lead times
Custom systems (UF/DF, CIP, buffer preparation)10–16 weeksIncludes design review, fabrication, FAT, documentation, and shipment

For urgent or expedited orders, please contact our sales team directly — we maintain safety stock of commonly used valve sizes and pump components, and can sometimes expedite standard configurations.


Q9. What documents are included with each order?

We understand that in regulated industries, documentation is as important as the physical product. Every shipment includes a standard document package to support your validation activities:

• Certificate of Conformance (CoC): confirms the product was manufactured per order specifications and quality procedures, and has passed functional testing and dimensional verification before shipment

• EN 10204 3.1 Material Certificate: for diaphragm valve bodies and diaphragm pump heads, providing material reports with corresponding heat numbers

• Operation & Maintenance Manual: electronic version

For custom systems and larger equipment packages, we also provide:

• Product risk assessment: Quality Project Plan (QPP), System Classification (SC), Component Criticality Assessment (CCA), Risk Assessment (RA)

• Design qualification / design review: Design Qualification (DQ), Functional Specification (FS), Hardware Design Specification (HDS), Software Design Specification (SDS)

• C&Q testing and documentation: Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ)

• Certificate documents: Product inspection report, wetted component material certificate, product certificate of conformity, product quality certificate, calibration certificate

• Process documentation: Surface roughness documentation, pickling and passivation documentation, welding documentation

• List-type documents: I/O list, Alarm List (AL), Parts List (PL), Consumables List (CL)

The specific document package can be tailored to your project Validation Master Plan (VMP) requirements. If your project follows a specific format, please share it with us and we will match accordingly.


Q10. What are your payment terms?

Standard payment terms for international orders:

• 30% T/T advance — upon order confirmation (to initiate manufacturing and material procurement)

• 70% balance before shipment — after FAT completion and customer approval, or before goods leave our facility

For established customers with good credit history or large system projects, other terms can be negotiated:

• Letter of Credit at sight (L/C) — typically for large capital equipment orders

• Milestone payments (e.g., 30% order, 30% materials, 30% FAT, 10% shipment)

All prices are quoted in USD unless otherwise agreed. A Proforma Invoice (PI) will be issued upon order confirmation, including specifications, quantity, unit price, total value, and delivery terms.


Q11. Which Incoterms do you support?

• entire logistics chain to your facility, including import customs clearance and (for DDP) duties and taxes. This is the most hassle-free option for customers.

For pharmaceutical equipment, we work with freight forwarders experienced in handling sensitive cargo — including temperature-controlled containers, vibration monitoring, and careful handling to prevent damage to precision equipment in transit. Packaging includes fumigated export wooden cases, moisture barriers, and vibration indicators for sensitive instruments.


Q12. Do you have overseas distributors? How can I become your international partner?

We are actively expanding into international markets and have already established partnerships with local distributors and system integrators in some regions. As our global business grows, we continue to seek new regional partners.

We look for partners with:

• Existing customer base in biopharmaceutical or fine chemicals

• Ability to provide local sales and basic technical support

• Alignment with our product philosophy and quality standards

We offer partners:

• Regional exclusivity protection

• Competitive distribution pricing and margin structure

• Comprehensive product and application technical training

• Marketing materials and project support

• Responsive technical support and spare parts supply

If you are interested in becoming a partner in your region, please contact our international sales team.


Q13. What is your warranty period?

• ical support and spare parts supply

If you are interested in becoming a partner in your region, please contact our international sales team.

Standard warranty for all Lizhi indusry products:

• 12 months from shipment — valves, pumps, adapters, and system equipment, covering defects in materials and workmanship under normal operation and proper installation

• 6 months — consumable/wear parts (diaphragms, tubing, seals, O-rings) under normal use conditions

The warranty covers free replacement of defective parts during the warranty period (ex works Shanghai). We do not cover damage caused by:

• Misuse, improper installation, or operation outside specified parameters

• Modification or repair by unauthorized personnel

• Damage caused by use of non-Colent spare parts or accessories

• Normal wear of consumables beyond rated service life

For critical production applications, we also offer extended warranty packages (up to 24 months) and service agreements — including annual preventive maintenance, spare parts packages, and priority technical support. Contact us for details.


Q14. How do I order spare parts?

Spare parts availability is critical to minimizing production downtime. We maintain stock of the most commonly needed wear parts for our standard products:

• Diaphragms (EPDM and PTFE/EPDM, full size range)

• O-rings and seal kits

• Actuator repair kits (seals, springs, pistons)

• Pump valve plates and diaphragm kits

When ordering spare parts, please provide:

• Original purchase order number or product serial number (on the product nameplate)

• Part description or part number from the operation manual

• Required quantity

Our service team will confirm the correct parts, stock availability, and provide pricing and lead time. Stock items ship from Shanghai within 1–2 business days. International express (DHL/FedEx) typically reaches major pharmaceutical markets in 3–5 business days.


Q15. Do you provide English technical support?

Yes. Our sales, application engineering, and service teams all communicate in English. We provide:

• Pre-sales consultation: process selection, valve selection, pump model recommendation — based on your process conditions and P&ID

• Technical documentation: datasheets, dimensional drawings, operation manuals, and compliance certificates are all available in English

• Troubleshooting: for operational issues (valve leakage, pump flow deviation, actuator not responding, etc.), our engineers can diagnose via email, photos, video call, or remote desktop

• On-site support: for large projects or critical issues, we can arrange on-site engineering support. Travel costs are billed per labor hours and materials

Technical inquiries are typically responded to within one business day. For urgent production issues (e.g., batch delay due to valve failure), please mark "URGENT" in the email subject line and we will prioritize accordingly.


Q16. How can I contact Lizhi industry?

The fastest way to reach our international sales and engineering team is through our website:

• Visit Lizhi-industry.com

• Click the "Inquire" / "Contact Us" button on any product page

• Fill in your name, company, email, and inquiry details

Our sales representative will respond within one business day (Shanghai time, UTC+8). For technical inquiries, please include as much of the following as possible:

• Your application (e.g., "UF/DF feed pump for 500L bioreactor harvest")

• Required flow rate and pressure

• Process fluid characteristics (viscosity, temperature, pH, special chemicals)

• Any regulatory requirements (FDA, USP Class VI, ASME BPE, etc.)

• Your target timeline and quantity

The more detailed information you provide, the faster we can recommend the right product and provide an accurate quote.

Didn't find your answer?

Send us a question through the contact form on our website at Lizhi-industry.com, and our technical team will respond within one business day. For urgent production or technical issues, please include "URGENT" in the email subject line and we will prioritize accordingly.