Custom Single-Use Assemblies

Single-use assemblies are designed to be flexible, efficient and cost-effective in the manufacturing of biopharmaceutical products. They’re widely used in the producing of vaccines, antibodies, recombinant proteins, and gene therapy, helping ensure products stay free from the risk of microbial contamination and avoiding cross-contamination during product switching between different projects.

With over 20 years of experience in the pharmaceutical and biopharmaceutical industries, Cobetter provides a comprehensive single-use assemblie products include: Tubing Assemblies, Bag Assemblies, Filter Assemblies, Bottle Assemblies, PUPSIT Assemblies, Final Filling Assemblies, and more.

At Cobetter, we prioritize quality and compliance at every stage of our single-use assembly production. Our thorough Quality Management System (QMS) ensures all components meet strict industry standards—from design and manufacturing all the way to final delivery.

Our production and quality management processes comply with the requirements of the ISO9001:2015 quality management system. Our production sites are all certified by ISO 9001:2015. Learn more about Cobetter Quality Management System.

Besides standard compliance documents, we also offer a range of validation services to ensure every component meets your quality and regulatory requirements.

1. What are single-use assemblies?
Single-use assemblies are pre-sterilized and pre-assembled systems used in bioprocessing for fluid transfer, mixing, and filtration. They usually consist of various components like tubing, connectors, filters, bags or bottles, sampling and sensor ports—customized to your process needs.

2. What is the cost of custom single-use assemblies?
Costs depend on design complexity, materials, and quantity, but we offer flexible ordering—including prototypes without minimum quantity—so you pay only for what you need.

3. What are some examples of single-use assemblies?
Typical examples include tranfer sets, tubing manifolds, bag assemblies, filter assemblies, bottle assemblies, sampling assemblies, final filling assemblies and various custom sets tailored for specific applications.

4. Can I have sensors in my assembly?
Yes. You can add sensors for pressure, flow, pH, or other measurements depending on your process requirements.

5. How long does it take to design a custom assembly?
Design usually takes a few days to a couple of weeks, depending on complexity. After design approval, manufacturing typically takes less than 4 weeks.

6. What are single-use bags made of?
Cobetter single-use bags are made from our in-house Topene RB blown film, composed of ULDPE (ultra-low density polyethylene), EVA (ethylene-acetic acid ethylene copolymer), EVOH (ethylene-vinyl alcohol copolymer) and LDPE (low density polyethylene). The Topene RB film features an ultra-clean inner surface, excellent environmental stress crack resistance, tear resistance, rubbing resistance, tensile resistance, chemical stability and biological safety.

7. How long is the shelf life of custom single-use assemblies?
When stored in their original packaging under controlled conditions, Cobetter single-use assemblies have a shelf life of 2 years.

8. What are the benefits of custom single-use assemblies?
They reduce contamination risks, save cleaning time, lower labor costs, speed up product changeovers, and offer flexibility for scaling and customization.

9.Are single-use assemblies more expensive than stainless steel systems?
While the per-use cost may be higher, single-use assemblies save money overall by cutting cleaning, validation, and labor expenses. They also reduce downtime, which can add up to significant savings. Learn more about how single use assemblies reduce cost and speed up time to market.

10. What are the disadvantages of single-use technology?
They generate more plastic waste, require proper disposal, and sometimes have limits on chemical or temperature compatibility compared to stainless steel systems.