|
| Brand Name: | HJW |
| MOQ: | 1set |
| Price: | US$14700~US$15000 |
| Payment Terms: | L/C,D/P,T/T,Western Union |
| Supply Ability: | >300sets/month |
I.Overview
Ultrafiltration (UF) equipment plays a key role in the pharmaceutical industry for separation, purification, concentration and pyrogen removal to meet the high purity requirements of drug manufacturing.
The core values are: high purity assurance (removal of pyrogens, viruses, impurities, compliant with pharmacopoeia standards),
process flexibility (applicable to a wide range of products such as antibodies, vaccines, gene therapy, etc.), and design for compliance (meets the stringent validation requirements of GMP/FDA/EMA).
II.Typical Process Flow
Monoclonal Antibody (mAb) Purification:
Cell Culture Solution → Centrifugation/Deep Filtration → Ultra Filtration (30 kDa) → Protein A Chromatography → Viral Filtration → Ultra Filtration Dialysis (Liquid Exchange) → Preparation
Water for Injection (WFI) for pyrogen removal:
purified water → multi-effect distillation / RO → ultrafiltration (10 kDa) → UV disinfection → storage and distribution
Concentration of viruses for vaccine production:
Virus culture solution → microfiltration (0.22 μm) → ultrafiltration (300 kDa) → sucrose gradient centrifugation → inactivation/freeze-drying
III.Core Attribute Parameters
| Performance Requirements for Ultrafiltration Membranes (Pharmaceutical Grade) | |||||||
| Parameter | Pharmaceutical Grade Standard | Description | |||||
| Membrane Material | Regenerated Cellulose (RC), PES | RC: Low protein adsorption; PES: Resistant to acid-base cleaning. | |||||
| Molecular Weight Cut-Off (MWCO) | 1–300 kDa | Antibody purification: 100 kDa; Pyrogen removal: 10 kDa. | |||||
| Flux (LMH) | 20–100 (Adjusted by Viscosity) | High-viscosity feed (e.g., DNA) requires low flux. | |||||
| Operating Pressure | 0.5–3 bar | Tangential Flow Filtration (TFF) mode reduces concentration polarization. | |||||
| Integrity Test | Bubble Point Test ≥3 bar | Ensure membrane integrity; meet GMP validation requirements. | |||||
| Key Quality Control Indicators | |||||||
| Application | Output Standard | Regulatory Basis | |||||
| Pyrogen Removal for Injections | <0.001 EU/mL | Chinese Pharmacopoeia 2020 Edition | |||||
| Blood Products | Viral Reduction ≥4 log (99.99%) | FDA/EMA Viral Safety Guidelines | |||||
| Biologics | HCP ≤5 ppm | ICH Q6B Quality Standar | |||||
IV.Core Application Areas
Biologics Purification
Blood Products Processing
Injectable Pyrogen Removal
Enzyme Concentration
Chinese Medicine Modernization
V.Here is a guideline for you to get a proper quotation
Tell us the raw water/source of water(tap water, well water, or sea water, etc)
Provide water analysis report(TDS , conductivity, or resistivity, etc)
Required production capacity( 5m³/H, 50m³/H,or 500m³/H, etc)
What's the pure water used for( industrial,Food and Beverage,or agriculture, etc )
english
français
Deutsch
Italiano
Русский
Español
português
Nederlandse
ελληνικά
日本語
한국
العربية
हिन्दी
Türkçe
indonesia
tiếng Việt
ไทย
বাংলা
فارسی
polski
