產品名稱：SaniPure BDF生物制藥管|Saint-Gobain軟管

SaniPure BDF生物制藥管|Saint-Gobain軟管，應用于熱合及無菌焊接，無動物源材料證明，可用于生物制藥行業。

產品特點：
 Certified to be free of materials of
 animal origin
 Ultra-smooth inner bore reduces
 potential for particle entrapment
 Documented biocompatibility for
 sensitive applications
 Meets USP Class VI, EP 3.2.9 & FDA criteria
 Non-cytotoxic, non-pyrogenic, and
 non-hemolytic
 Extremely low absorption and adsorption
 compared to silicone tubing
 Heat sealable, bondable, sterile-
 weldable, and custom moldable for
 assemblies
 Superior peristaltic pump life
 Fully autoclavable and sterilizable
SaniPure BDF (Bovine Derivative Free)

Saint-Gobain Performance Plastics has developed SaniPure BDF, a breakthrough innovation
in polymer high-performance materials. SaniPure BDF is completely certified to be free of
materials of animal origin and is the ideal choice for handling sensitive biological fluid transfer
applications. SaniPure BDF combines the features of traditional silicone tubing with superior
peristaltic pump life performance and low absorption characteristics. This tubing answers the
industry’s requirements for performance, characterization, and animal-free origination.

SaniPure BDF生物制藥管|Saint-Gobain軟管特性：
SaniPure BDF has an ultra-smooth inner bore which drastically reduces potential particle
entrapment and microscopic build-up during critical fluid transfer processes. This smooth
fluid path also helps facilitate complete sanitation of the fluid transfer system and improves
flow characteristics by reducing surface area.
The innovative design of SaniPure BDF creates an advanced tubing formulation that has
an absorption rate lower than virtually all elastomeric tubing currently in use, making it the
obvious selection when fluid integrity must be maintained throughout the process. This will
also ensure that common preservatives which are added during processing are fully
optimized.
SaniPure BDF生物制藥管|Saint-Gobain軟管生物適應性：
SaniPure BDF tubing complies fully with the requirements of USP Class VI, European
Pharmacopeia 3.2.9 and FDA 21 CFR Part 177.1210 criteria and is entirely non-cytotoxic,
non-pyrogenic, and non-hemolytic.
To ensure the superior characteristics of SaniPure BDF the following tests were also
performed: Genotoxicity Tests, Bacteriostasis – Fungistasis Tests, Physiochemical Testing
for Elastomeric Closures (USP <381>), Physiochemical Testing for Plastics (USP <661>),
and Total Extractables (per 21 CFR 177.2600). SaniPure BDF tubing has a masterfile
with the U.S Food and Drug Administration.

應用：
 Sterile filling and processing
 Cell harvest and media process systems
 Vaccine production
 Production filtration and
 fermentation
 Cell and tissue culture transport
 Drug delivery systems
 Diagnostic equipment and
 laboratory research
 Bioreactor process lines
 High-purity water transfer
 Buffer solutions

型號：
AR400001
AR400002
AR400003
AR400007
AR400012
AR400013
AR400017
AR400018
AR400019
AR400027
AR400029
AR400038