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TPE COMPOUNDS FOR PHARMACEUTICAL STOPPERS
The Change of Materials in Pharmaceutical Stoppers
Pharmaceutical stoppers are used to seal injections and drug ampoules that are manufactured in extremely large numbers. For pharmaceutical packaging such as pharmaceutical stoppers, strict requirements and demands apply with regard to hygiene, safety, and function. Nowadays, rubbers are still often used as the basic material for manufacturing such applications. The problem with these, however, are the NIAS (non-intentionally added substances). These are substances that are added unintentionally, and some of these can represent a hazard to health, putting patients and personnel at risk. A special production technique is also required for making stoppers out of rubber, one that only a few companies actually offer. This significantly constrains product availability. The production process with rubber also generates a lot of waste, which is contrary to the demand for greater sustainability and cost-effectiveness.
Against this background, the fact that butyl rubber is still the standard material used in some cases for the production of pharmaceutical stoppers is all the more astonishing. The industry has actually long since realigned its processes to favor a rubber-free material solution. With ProvaMed® TPE, a more sustainable and cost-effective alternative has already been created from TPE.
Please contact us for further information on the use ProvaMed® and its individual advantages.CONTACT
100 % regulatory compliance
The products pass the physico-chemical tests prescribed in USP 381, as well as the ISO 10993-5 cytotoxicity test. The tests have been carried out by an external, independent testing laboratory and its testing certificates are available on request. In addition, the materials fulfill all regulatory functions according to USP 381, such as resealability after piercing with a cannula.
The materials have excellent properties in relation to resealability. Even after being pieced multiple times with an 0.8-mm-diameter cannula, the materials maintain a complete seal.
With ProvaMed® TPE, standards-compliant results can be achieved with regard to fragmentation, guaranteeing protection for patients and safe handling.
Pharmaceutical stoppers made from ProvaMed® TPE impress with safe handling and first-class user-friendliness, since they are easy to pierce with little force required.
Sterilizability was verified by observing the mechanical properties before and after each sterilization method (as per the table).
|ProvaMed® 6145 TL||ProvaMed® 6245 NC||ProvaMed® 6345 NC|
|Autoclave 121 °C||✔||✔||✔|
|Autoclave 134 °C||✔||✔|
|Ethylene oxide (EtO)||✔||✔||✔|
|Gamma radiation 25 kGy||✔||✔||✔|
|Gamma radiation 50 kGy||✔||✔|
Using ProvaMed® TPE is considerably more profitable than the use of conventional materials. Unlike rubber, TPE can be recycled and reused. The general material costs and cycle times are lower and there is less waste.
Benefits of our ProvaMed® TPE for pharmaceutical stoppers
- Offer sustainable protection to patients and medical personnel. With ProvaMed® TPE as your pharmaceutical stopper material, you can achieve maximum cleanliness, hygiene, and reliability for your application.
- Since our ProvaMed® TPE plastic granules are permanently available and we can offer our customers delivery on demand, you can avoid bottlenecks in your material supply chain and therefore avoid downtimes in your plant.
- Our tested and verified ProvaMed® TPE plastics facilitate your work as a distributor of pharmaceutical stoppers and medical closures in regulatory qualification and compliance matters and reduce concerns around complying with the Medical Device Regulation by using non-cytotoxic TPE plastic granules that have already been successfully tested according to USP 381, enabling you to take a key step toward successful qualification.
Learn more about ProvaMed® TPE solutions for pharmaceutical stoppers and get our product brochure here.
Request your Sample
Experience the ProvaMed® TPE compounds in action with our pharmaceutical stopper sample. See the outstanding properties regarding resealability, fragmentation and penetrability.