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Bio

Bio

Globally Certified Bio Single-Use Bags & System

With cutting-edge production environments and quality systems, our bio division manufactures single-use bags and systems that are essential for biopharmaceutical processes.

01 Product Overview

Single-Use Bags

Assembly

01

Our portfolio covers a broad range of products, from 2D, 3D, to liner bags.
02

We specialize in producing single-use bags and systems for bioprocessing.
03

Prompt response to both standard and custom product requests.

02 Product Lineup

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 Manufacturing Environment and Facility

ISO Class 7 Cleanroom

- Each process is carried out in a separate, dedicated workspace to minimize
the risk of cross-contamination.
- GMP compliant environment
- Provide high quality production

Equipped with cutting edge helium leak tester

05 Quality System and Certification

Key Features

ISO 13485:2016 Certification

Products produced in ISO class 7 cleanroom

Meets global standards - ISO, USP, EP including FDA class VI

Extractables test performed according to BPOG protocol

Bacterial endotoxin study performed

Delivery after 100% helium leak test

Delivery after 100% Visual Inspection

Sterilized by gamma irradiation

Certification and TEST report

ISO 13485 Certification

Quality System Conforms to ISO 13485 Standard

Extractables test Report

(according to BPOG protocol)

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