TPE for Medical Drip Chambers

PVC and the plasticizers associated with it increasingly subject to criticism. There has long been a shift in people’s thinking in favor of PVC-free and therefore more sustainable solutions. The market for medical drip chambers is beginning to turn around.​

ProvaMed® TPE D1341 TP, ProvaMed® TPE D1345 TP and ProvaMed® TPE D1349 TP represent safe solutions for the high demands on performance and safety for medical drip chambers. They enable the realization of complex designs in elastic and ultra-transparent drip chambers.

Do you have any questions? Contact us and we will be happy to advise you on your individual requirements.

Product features

High transparency​

Apart from absolute health safety, drip chambers also require outstanding transparency with a well-balanced degree of flexibility, rigidity and durability. Our ultra-transparent TPEs permit perfect optical control of the drip process as well as easy and swift adjustments to the fluid level.​

Sterilizability​

Our TPEs for drip chambers can be sterilized using ethylene oxide (EtO) and gamma rays - without any negative impact on the material properties and without impairing the function of the adhesion sites, e.g. between the drip chamber and the tube. Sterilizability has been verified by an external, independent test laboratory.​

Bonding ability​

Our TPEs offer an outstanding level of solvent bonding. Furthermore, ACTEGA avails of material solutions with a high precision fit between the tube and the drip chamber material. This has been tested in an extensive range of tests – in line with ISO 5836-4 – using solvents which are established in the sector, i.e. tetrahydrofuran (THF), methyl ethyl ketone (MEK), and cyclohexanone.

100% regulatory conformity

  • Compliance with regulatory requirements​
  • USP class VI, <88> biological reactivity tests, in vivo​
  • In accordance with USP VI, biological tests for plastics​
  • Testing TPEs in accordance with ISO 10993-5​
  • Production in line with GMP Directive (EC) 2023/2006

During the manufacturing process

  • Optimized material flow for injection-molding​
  • Very good processing properties​
  • MFI and flow performance ensure attractive cycle times

During application

  • Well-balanced degree of rigidity and recoverability​
  • Pleasant haptics

Realize faster projects thanks to the confirmed quality of our TPE compounds and the very best support in all service areas.

Florian Schindler

Product Manager New Business Development

Benefit from the advantages of our ProvaMed® TPEs for drip chambers:

Protect patients and medical personnel over the long term. Our TPE solutions free of plasticizers attribute your medical technology valuable functions while complying with maximum demands on cleanliness, hygiene and safety.​

ProvaMed® TPEs offer you more flexibility, freedom of design, and extra sustainability. Use conventional solvents to bond the components made from soft PVC with those made from TPE or use our TPE solutions for drip chambers and infusion lines to design infusion sets which are entirely free of PVC. By doing so, you can reduce the volume of harmful PVC containing plasticizers in your products while working significantly more efficiently thanks to shorter cycle times and less installation effort.​

Design the qualification process for your medical products in an efficient and smooth manner. Our products have already been tested in accordance with ISO 10993-5, achieving outstanding results, for stress-free and easier qualification of your medical product

Product brochure

Find out more about the ProvaMed® TPE solutions for drip chambers and download our product brochure.

White paper

Drip chambers – The problem with plasticizers.

Do you have any questions? Contact us and we will be happy to advise you on your individual requirements.

Are new tools required for processing TPE for drip chambers?​

We can answer this question with a resounding No! Like soft PVC, TPE are ideal for processing in injection-molding and even on the same machines with the result that no new investments are required. Both the drip chamber and the tube components can be made thanks to this processability in injection-molding. ACTEGA relies on TPE-S solutions here, whereby a conscious effort is made to dispense with the use of plasticizers and ingredients containing BPA or phthalates, which also translates into our contribution to sustainability.​

Does gamma sterilization impair transparency of the drip chambers manufactured from ProvaMed® TPE?​

ProvaMed® TPE for drip chambers can be sterilized with both ethylene oxide (EtO) and gamma rays. And without any negative impact on the material features or on the functionality of the bonding points, such as between the drip chamber and the tube. Unlike soft PVC, which often tends to discolor after sterilization by gamma rays, this does not happen to TPE, something which has also been verified by independent test institutes. In the case of high-energy, ionizing gamma rays, which inactivates microorganisms, the materials are sterilized with doses of 25 kGy and 50 kGy. Apart from ionizing radiation, i.e. alpha, beta and gamma rays, artificial forms of radiation – such as electron beams or e-beams – are also available, where the sterilization process only takes a few seconds and is less energy-intensive than gamma radiation. As not all plastics have proven suitable for these sterilization processes, it is of advantage that the ProvaMed® TPE are eminently suitable in this regard.​

Are the materials used for drip chambers and IV sets compatible with the medication administered, e.g. with cytostatics?​

As PVC is not compatible with some medication, such as cytostatics, for example, and cannot therefore be used, we always need to examine in great detail any interactions in advance when PVC comes into direct contact with medication. Therefore, it is advantageous during therapy, e.g. in oncology, if TPE have been used for manufacturing drip chambers and IV sets as they are generally compatible. Other active ingredients, which are not suitable for contact with PVC, include taxol, nitroglycerine, diazepam or even insulin.​

Currently ACTEGA offers three TPE products (ProvaMed® D1341 TP, D1345 TP and D1349 TP) for medical drip chambers: Are there any other products in other Shore hardnesses or will they be available in the foreseeable future?​

Our designers have been working intensively on many different formulations from which they have developed a whole range of other variants featuring various configurations, e.g. in terms of modulus of elasticity, rigidity, flexibility, resilience, and bonding capacity with various materials. As a result, there is a wide portfolio of TPE formulations available for drip chambers and IV sets. For example, we have already included a softer, equally ultra-transparent TPE variant in the portfolio, which displays a Shore hardness of A-80. The portfolio of ProvaMed® TPE formulations is steadily growing, becoming increasingly extensive, and can be tailored to any specific drip chamber application.​

What advantage is there to PVC-free and what is bad about PVC?​

Some may ask themselves why PVC, which has proven its worth in many medical applications, is even subject to criticism at all, considering the fact that it is regarded as being such an inexpensive material with good processing properties. The problem is multi-layered, even if a patient is only “on a drip” once for a manageable period of time, which is rather rare in any case. Many people need regular use and/or for a longer period of time or are undergoing long-term therapy. But there are two other reasons, too: on the one hand, plasticizers can dissolve out of the PVC material; on the other hand, certain active pharmaceutical ingredients are deposited on the PVC surface. This adsorption is then accompanied by undesired loss of active ingredient, i.e. lower dosage. And beyond that, it is necessary not to lose sight of the environmental problem that arises when disposing of PVC. For this reason, many people have already started to rethink the use of PVC-free materials.​

Our brands for medical TPE

PROVAMED®

Portfolio of standard products for medical technology and for customized TPEs for highly-sensitive areas of application.