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中试发酵罐

Pilot Fermenters

Model No. PIF-0003 · Fermentation Equipment

Pilot Single-Use Fermenter

一次性使用中试发酵罐

Clinical batches and multi-product pilot suites avoid cleaning validation with a single-use fermenter. Gamma-irradiated bags of 50–500 L sit in a reusable support, mixed by impeller, rocking or wave, at 10–50 °C with cascade DO from single-use sensors. Bags are rated to 0.2–0.5 bar, with BPOG and USP <661> extractables data.

Working volume
50–500 L
Bag material
Multi-layer polyethylene film
Sterilization
Gamma irradiation 25–40 kGy
Mixing
Impeller, rocking or wave
Temperature range
10–50 °C
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Packing & Shipping

Place of originChina (dispatched from Shanghai)
BrandLiquid International / OEM on request
Export packingFumigation-free plywood case or reinforced carton
Loading portShanghai / Ningbo (others on request)
Payment termsT/T, L/C at sight (confirmed on quotation)
Trade termsEXW, FOB, CFR, CIF, DAP

Typical export terms — final terms are confirmed on the proforma invoice.

Product Description 产品描述

Clinical batches and multi-product pilot suites avoid cleaning validation with a single-use fermenter. Gamma-irradiated bags of 50–500 L sit in a reusable support, mixed by impeller, rocking or wave, at 10–50 °C with cascade DO from single-use sensors. Bags are rated to 0.2–0.5 bar, with BPOG and USP <661> extractables data.

Highlights

  • No cleaning validation between products
  • 50–500 L bag volumes
  • Three mixing options
  • Extractables data for regulatory files

Applications

  • Clinical batch production
  • Multi-product pilot manufacturing
  • Scale-up process development
  • Shear-sensitive culture scale-up

Specifications 技术参数

ParameterValue
Working volume 工作体积 50–500 L
Bag material 袋材质 Multi-layer polyethylene film
Sterilization 灭菌方式 Gamma irradiation 25–40 kGy
Mixing 混匀方式 Impeller, rocking or wave
Temperature range 温度范围 10–50 °C
Dissolved oxygen control 溶解氧控制 Single-use sensor, cascade control
Pressure rating 压力等级 Up to 0.2–0.5 bar
Extractables testing 浸出物检测 BPOG and USP <661> aligned studies
Model No.PIF-0003
Place of originChina (dispatched from Shanghai)

Applicable standards 适用标准

EU GMP Annex 1 EU GMP Annex 11 21 CFR Part 11 21 CFR Part 211 GB/T 150 USP <87> USP <88> ICH Q11 IEC 61010-1

Chinese national standards (GB/T, JJG) and international standards referenced for this product type. Test reports and certificates are supplied with the quotation on request.

Packing & Shipping 包装与运输

Export packing

Fumigation-free plywood case or reinforced carton

Every unit is power-tested before packing; enclosed in shock foam and moisture barrier; wooden cases comply with ISPM 15.

Loading port

Shanghai / Ningbo (others on request)

Full container load (FCL), less-than-container load (LCL) or air freight; complete export documentation provided.

Inquiry Now 索取报价

Complete the form below — an export engineer will send technical configurations and a formal proforma invoice within 24 hours.

Products in this inquiry: Pilot Single-Use Fermenter (PIF-0003)

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