LMS THE TECHNOLOGY!
  • home
  • 事業部門
  • バイオ

バイオ

Globally Certified Bio Single-Use Bags & System

バイオ事業部は先進化した生産環境と品質システムを備えて バイオ製薬工程に必要なSingle-use bagとシステムを生産しております。

01 製品紹介

Single-Use Bags
Assembly
  • 01
    2D, 3D, Liner Bag ポートフォリオ保有
  • 02
    バイオプロセシングのための Single-use bagとシステムを生産
  • 03
    標準型製品と顧客注文型製品両方とも 迅速対応

02 製品種類

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 生産環境及び施設

ISO Class 7 Cleanroom
  • - 交差汚染防止のための工程別独立作業室を運営
  • - GMP-Compliant 生産環境
  • - Provide high quality production
Equipped with cutting edge helium leak tester

05 品質システム及び認証書

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
認証書及びテスト報告書
ISO 13485 Certification

Quality System Conforms to ISO 13485 Standard

Extractables test Report

(according to BPOG protocol)

엘엠에스 신문고

제목
내용
첨부파일