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. What ISO classifications apply to the manufacturing of Cobetter single-use bags?
Cobetter operates one ISO class 4.8 workshop (equivalent to GMP Class A) dedicated to the production of filling system–related products. In addition, Cobetter is equipped with eleven ISO Class 7 and ISO Class 8 production lines for the manufacture of single-use storage bags, mixing bags, and customized tubing assemblies.
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. What tests are typically performed on Cobetter single-use bags prior to release?
A Certificate of Quality is provided with each shipment, listing routine test items and applicable reference standards. These tests include bag integrity, endotoxin levels, sterility, and insoluble particulate matter, among others.
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.
