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Globally Certified Bio Single-Use Bags & System

Bio事业部门具有先进的生产环境和质量体系, 生产生物制药工艺所需的单件包和系统。

01 产品简介

Single-Use Bags
Assembly
  • 01
    拥有2D、3D、Liner Bag 投资组合
  • 02
    为了生物工程处 理与系统生产
  • 03
    标准型产品和客制产品 迅速应对

02 产品种类

BioCELVAS 2D Bags
Sampling
50ml, 100ml, 200ml, 500ml, 1L, 2L
Storage
5L, 10L, 20L, 50L
BioCELVAS 3D Bags
Storage
50L, 100L, 200L, 250L, 500L, 1,000L
BioCELVAS Liner Bags
Storage
20L, 50L, 100L, 200L, 300L, 370L, 560L

03 Application

Application Bag Types Used
Media & Buffer preparation Liner bags, 2D bags, 3D bags
Storage of cell fluid, intermediate products, final products 2D bags, 3D bags
Sampling 2D bags
Shipping & Transportation 2D bags, 3D bags
Wastes Collection Liner bags

04 生产环境及设备

ISO Class 7 Cleanroom
  • - 为防止交叉污染,各工序运营独立工作室
  • - GMP-Compliant 生产环境
  • - Provide high quality production
Equipped with cutting edge helium leak tester

05品质系统及认证书

Key Features
01
ISO 13485:2016 Certification
02
Products produced in ISO class 7 cleanroom
03
Meets global standards - ISO, USP, EP including FDA class VI
04
Extractables test performed according to BPOG protocol
05
Bacterial endotoxin study performed
06
Delivery after 100% helium leak test
07
Delivery after 100% Visual Inspection
08
Sterilized by gamma irradiation
认证书及TEST报告书
ISO 13485 Certification

Quality System Conforms to ISO 13485 Standard

Extractables test Report

(according to BPOG protocol)

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