Bioprocess Single Use Sampling Bags used for vaccine production biotechnology

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.

Introduction:

In every pharmaceutical process, each sampling is an extremely critical and unavoidable step, used for monitoring process parameters to ensure the stability, safety, and controllability of the entire process. Our single-use sterile sampling bag is a pre sterilized, self sealing sampling bag designed and made of materials with excellent physical and chemical stability and biological safety, and can be perfectly integrated with the sampling system. During the entire sampling process, there is no risk of cross contamination, and a closed design ensures that your sample remains isolated from the sampling point to analysis, reducing the loss of valuable products. You can take samples at any stage of the process in a sterile, safe, and convenient manner, achieving reliable and complete process monitoring. Suitable for process monitoring in biological processes, avoiding cross contamination and ensuring the safety of the production process.

Characteristic：

· Cell culture process sampling.

· Sampling of microbial fermentation process.

· Liquid preparation process sampling.

· Storage and transport of small scale media and buffers.

· Storage and transfer of intermediate or semi-finished products, etc.

Application:

· GMP quality assurance:

· Strictly controlled from raw materials, stable EVA material can withstand low temperature (-196) for a long time.

· Comprehensive supervision and control of manufacturing process and quality to ensure product safety and stability.

· Rich external configuration, equipped with pin jack, Luer interface, needle-free dosing parts.

Single sampling bag or multiple sampling bags：

Introduction:

The disposable sampling bag is suitable for sampling in different containers and different process stages. It adopts a design that combines a needle free sampling valve and a Ruhr connector, which is easy to use, safe, fast, and easy to operate. Flexible customization of single or multiple samples can be achieved based on process requirements.

Advantages:

The needle free sampling valve design is safe and convenient to use.

Flexibly customize the sampling frequency according to process requirements.

Flexible selection of sterile disconnecting rings, sterile disconnecting devices, and welded pipes.

Three sterile disconnection methods.

Application:

Sterile sampling of all biological process stages such as liquid preparation, storage, cultivation, and purification.

We provide various customized services (OEM&ODM) to global buyers, informing us of the requirements for bioprocess single use bags or other equipment, such as pipeline materials, length, diameter, clamp types, usage or photos of the products currently in use. You can also inquire with us based on the standard model numbers listed below.

Standard bag order information: