Soft Elastic News 12/2020 | TPE for injection seals

Dear Customer,

​​​​​​​People all over the world are suffering from Covid-19, the illness caused by the SARS-CoV-2 coronavirus. Companies and research institutes alike are working flat out to develop vaccines. At least 224 vaccine projects have been set up within a short period of time to fight SARS-CoV-2 which only appeared around the New Year. The World Health Organization (WHO) currently puts the figure at 212 (valid as at November 12, 2020), whereby Germany is regarded internationally as one of those countries working on a particularly high number of projects for vaccines against Covid-19.

The hunt for a vaccine

Where 15 to 20 years would have been estimated only a few years ago for analysis of the virus to approval of the vaccine, new technologies and previous experience with vaccine projects have made an enormous acceleration possible against related viruses. This is confirmed by intermediate results reported by some companies and research groups for their projects.

Among each individual receiving it, an ideal Corona vaccine would provide comprehensive and lifelong protection against infection with SARS-CoV-2 while causing only few and mild side effects. It is assumed, however, that no vaccine will meet this ideal target in full. Like the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) responsible for the approval of Covid-19 vaccines in the EU member states demands first and foremost that these vaccines are safe and that they have been convincingly confirmed in major clinical studies. The FDA has announced its intention to demand an effectiveness of at least 50 percent, i.e. in a larger group of vaccinated persons, maximum half the number become infected compared to a group of the same size of unvaccinated persons.

​​​​​​​Vaccination against Covid-19: initial successes apparent

It is not yet clear exactly when effective vaccines can be anticipated even if we often hear that a breakthrough is imminent. Just how fast vaccination campaigns can get up and running is not only dependent on how soon such safe vaccines are approved but also how fast how much vaccine can be produced. Furthermore, sufficient filling systems and the vials required for the vaccine must also be available.

And this is exactly where a possible bottleneck is anticipated. For this reason, the German government will fund the development of such filling systems with up to 250 million Euro, as well as promoting the actual vaccine itself. Among others, the Coalition for Epidemic Preparedness (CEPI) has offered the prospect of sufficient capacity. CEPI is a Product Development Partnership financed by Norway, Germany, Japan, Canada, and Australia as well as the Bill & Melinda Gates Foundation and the Wellcome Trust, to name but a few. We can only hope that all of these measures will lead to success as soon as possible.

Vial design and how they work

Let’s take a look at our business, e.g. the development of TPE compounds for vials. Vials are small bottles which are used in medicine and in chemical laboratories as single-dose or multiple-dose containers. Powdered drugs, solutions or suspensions can be filled into them. The bottles generally have a capacity of 1 to 200 ml. They are sealed with an injection seal or PTFE septum (penetrable membrane). This is attached to the neck with a crimp cap made of aluminum. The seal is least dense in the middle. This point is penetrated by the injection needle to draw in the injection fluid.

So much for the actual design. In accordance with the European Pharmacopoeia and the United States Pharmacopoeia (USP), the requirement profile must account for protection, safety, compatibility and function, and many of the material properties – physical and mechanical properties, processability, resistance to chemicals, cleanliness, hygiene or sterilizability – must be tested. Furthermore, test certificates in accordance with USP 381 are required for the injection or pharmaceutical seals used here. Specifically, the USP 381 includes evidence of physical-chemical and functional tests during which possible influential factors, changes and penetrability, fragmentation, and self-sealing are examined.

PROVAMED® 6145 TL, 6245 NC, and 6345 NC TPE

Various material applications of a variety of raw materials have been used to compound and extensively test the PROVAMED® 6145 TL, 6245 NC, and 6345 NC TPE for injection and pharmaceutical seals. In view of the highest demands on low migration, compatibility on contact with the human body, and FDA conformity, it has been possible to present formulae whose performance and conformity comply with USP 381. Accordingly, evidence has been provided of the fact that even after multiple piercing of the TPE material, no residue adheres to the needle or can be found in the test solution. This ensures that effective action can be taken to counter the risks of particle contamination. The sealant function prevents leakage of any components of the medication or vaccine.

The self-sealing features for safe resealing have also been confirmed, thereby minimizing the risk of contamination and therefore improving patient safety. With a force of less than 5 N (force for piercing the septum), the penetrability test represents an outstanding result. After all, a particular degree of purity can also be certified as there is no interaction with sensitive pharmaceuticals or active ingredients considering neither sulfur nor zinc or other cross-linkers are used which would be required in the case of vulcanized rubber, for example. PROVAMED® 6145 TL, 6245 NC, and 6345 NC TPE were subjected to conventional sterilization methods – superheated steam at 121 °C and 134 °C, ethylene oxide, and Gamma radiation (25kGy and 50 kGy). The tests did not reveal any significant changes in property profiles. The products are suitable for all standard sterilization processes. With a very low migration potential and dispensing with PVC and plasticizers, these TPEs represent a very clean solution for manufacturing push-through membranes, seals, and closures. Other benefits: Individual colorability is available as an option. These TPE are extensively documented with regard to their biocompatibility and they are also antiallergenic. We would be delighted to provide you with further details and test results.

ALTANA fundraising campaign

The last few months have seen the international community face challenging tasks, some of which are existential. In the form of a fundraising campaign, ALTANA will contribute toward supporting people particularly affected by the coronavirus pandemic. For this reason, a total of 50,000 Euro is to be donated to projects in Bangladesh, Malawi, and Yemen, selected in collaboration with the “Aktion Deutschland Hilft e.V.” charity.

Read more about the individual initiatives and click to vote on how the funds are to be distributed among the individual projects:

We wish you and your families a peaceful holiday season and a happy New Year 2021.
​​​​​​​Stay healthy!