Innovative Bioprocess Bags for Antibody and Vaccine Development Cdmo

• Customization: Available
• Industrial Use: Pharmaceutical
• Transparency: Transparent
• Layered: Functional Layer
• Hardness: Soft
• Basic Level: LDPE
• Heat Seal: Uldpe
• Functional Layer: EVOH
• Packaging: Bag
• Bag Sealing Methods: Cylindrical Bag
• Transport Package: Carton
• Origin: China
• HS Code: 3923290000

Product Description

Company Profile

Bioprocess single-use lining bags ucsed for biopharmaceutical antibody production, vaccine production, biotechnology, cell gene therapy, CGT gene therapy, cell therapy, CDMO

 

The products are manufactured in a clean room in accordance with ISO 14644 CLASS 7 standard and comply with the requirements of ISO 13485:2016 medical devices quality management system, ISO 9001:2015 quality management system and GMP related regulations, and are strictly controlled in all aspects from design and development, material selection, manufacturing to finished product inspection and release. Our products have established corporate standards according to USP, FDA, ISO, ASTM, Chp, Ep, YBB, etc. and are verified by qualified third-party testing laboratories, and the verification results are in compliance with Chp, YBB, USP<661>, USP<665>, USP<85>, USP87>, USP<88> Class Vl, USP<788>, ISO<1099>, and ISO<1099>. 788>, ISO<10993>SO<11137>, ASTM 1980-16, FDA CFR 177.2600, European Pharmacopoeia 3.1.9 standard requirements. We can provide complete system validation documents and technical support services to meet the needs of drug registration.

Single-use bags for biological processes, commonly known as single-use bioreactor bags, are specialized containers designed for the cultivation of cells or microorganisms in bioprocessing applications. These bags are used in the production of biopharmaceuticals, vaccines, and other biologically derived products. The term "single-use" implies that these bags are disposable after a single batch or use, reducing the risk of cross-contamination and eliminating the need for extensive cleaning and sterilization processes associated with traditional stainless-steel bioreactors.

Product Description

Introduction:

· Disposable lining bag has higher cost performance, open design, more convenient material delivery.
· The operating temperature shall not exceed 45ºC.
· Different shapes can be customized according to existing containers or requirements.
· Pipes can be matched according to demand.
· Gamma radiation sterilization (25-40kGy)

Product Parameters

Lining bag order information:
Circular lining bag

Product No.	Volume(L)	Configuration	Packing
TPG038-S	38	Tubing 1: 3/8*5/8 platinum vulcanized silicone tubing 30cm, TC25 connector, clamp	10 sets/carton
TPG057-S	57
TPG113-S	113

Special size customizable.