Model No. BIS-0001
Upstream Bioprocess System上游生物工艺系统
- Working volume
- 0.1–2,000 L
- Temperature range
- 15–45 °C, ±0.2 °C
生物工艺系统
Bioprocess Systems
Photo for reference; configuration may vary by order.
Model No. BIS-0003 · Biotechnology Equipment
Single-Use Bioprocess System
一次性使用生物工艺系统
Multi-product plants and clinical supply teams cut cleaning validation and changeover by going single-use. Bags from 1 to 2,000 L in multi-layer polyethylene are gamma sterilised at 25–40 kGy and fitted with sterile-weldable connectors and single-use pH and DO patches. Extractables studies follow BPOG and USP <661> approaches.
- Bag volume
- 1–2,000 L
- Bag material
- Multi-layer polyethylene film
- Sterilization
- Gamma irradiation 25–40 kGy
- Pressure rating
- Up to 0.2–0.5 bar (bag dependent)
- Temperature range
- 4–45 °C
Packing & Shipping
| Place of origin | China (dispatched from Shanghai) |
|---|---|
| Brand | Liquid International / OEM on request |
| Export packing | Fumigation-free plywood case or reinforced carton |
| Loading port | Shanghai / Ningbo (others on request) |
| Payment terms | T/T, L/C at sight (confirmed on quotation) |
| Trade terms | EXW, FOB, CFR, CIF, DAP |
Typical export terms — final terms are confirmed on the proforma invoice.
Product Description 产品描述
Multi-product plants and clinical supply teams cut cleaning validation and changeover by going single-use. Bags from 1 to 2,000 L in multi-layer polyethylene are gamma sterilised at 25–40 kGy and fitted with sterile-weldable connectors and single-use pH and DO patches. Extractables studies follow BPOG and USP <661> approaches.
Highlights
- No cleaning validation for product-contact parts
- Bag volumes from 1 to 2,000 L
- Sterile-weldable aseptic connectors
- Pre-fitted single-use sensors
Applications
- Clinical and multi-product manufacturing
- Cell culture and fermentation
- Buffer and media preparation
- Downstream filtration and transfer
Specifications 技术参数
| Parameter | Value |
|---|---|
| Bag volume 袋体积 | 1–2,000 L |
| Bag material 袋材质 | Multi-layer polyethylene film |
| Sterilization 灭菌方式 | Gamma irradiation 25–40 kGy |
| Pressure rating 压力等级 | Up to 0.2–0.5 bar (bag dependent) |
| Temperature range 温度范围 | 4–45 °C |
| Connectors 连接件 | Aseptic, sterile-weldable |
| Sensors 传感器 | Single-use pH and dissolved oxygen patches |
| Extractables testing 浸出物检测 | BPOG and USP <661> aligned studies |
| Shelf life 保存期 | 12–36 months, controlled storage |
| Model No. | BIS-0003 |
| Place of origin | China (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
ICH Q7
ICH Q11
USP <1050>
USP <661>
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.
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