The GMPTEC tubing assemblies are available sterile and ready-to-use or as non-sterile tubing systems. We will provide you with the best material depending on your requirements, whether the tubing assembly has to be autoclavable or gamma-sterilizable. GMPTEC always uses tubing which are already specified and validated, in order to simplify the validation of the whole assemblies for GMP processes.
Individual Single-Use Tubing Assemblies
Our cGMP tubing assemblies are produced and also packaged in an ISO class 7 cleanroom. Even sub-components like tubing, TC-fittings, sterile connectors and many more go through strict testing before being brought into the cleanroom. If necessary, there will be an additional cleaning process in order to assure to a high-quality product.
The single-use tubing assemblies are being built very accurately, independent of which type of connection you chose. We offer every possible solution, starting with the simple and also cost-efficient solution of a cable tie connection, to BarbLocks and Oetiker-clamps up to overmolding connections.
After an evaluation and analysis of your cGMP and lab processes we will assist you in the choice of the best materials and components. Our goal is to create a tubing assembly entirely meeting your requirements and without any malfunctions. It is of highest importance, that there will be no mistakes during the development phase, as the finished product will be delivered sterile and also double packaged. If a mistake is noticed after delivery, it is usually already too late, since an adjustment won’t be possible without contamination.
Based on many years of experience within the industry, you can rely on the expertise of our specialists. The whole planning and design phase of the assembly will be free of charge and allows you to make an independent decision if you would like to order the single-use assembly we designed. There won’t be very high costs for your initial acquisition and on-side trials, as our minimum purchase is commonly very low.
Tubing Assemblies Applications
- Upstream- and also downstream processes
- Fill and finish
- Transfer of initial solutions
- Tubing manifolds
- Tubing distributions
- Single-use filtration sets
- Not only Connection of containers, but also Connection set for bioreactors
- Vent piping
- Filling hoses
Tubing Assemblies are compliant to:
- USP Class VI
- USP <88>
- Endotoxin statement
- BST/TSE confirmation
- Irradiation up to 40kGy
- Clean room ISO class 7 production
- Use of any kind of tubing, filters, connectors, couplers, flanges and many more