Overview of the hottest medical functional packagi

Overview of medical functional packaging

the requirements for medical active ingredients, packaging and corresponding delivery solutions are constantly improving. Manufacturers, processors and material experts are working together to comply with the stringent requirements of certification authorities

here, the Federal Food and Drug Administration (FDA) has chosen a leading role, which defines the delivery system and all its components (including active ingredients and packaging) as pharmaceutical products. All delivery systems are not only used to protect drugs, but also undertake additional functions, simplify administration, and enhance the acceptance of drugs among consumers. In many cases, packaging has even been developed to the position where it constitutes the actual dispensing system. Therefore, the U.S. approval department has put forward the same strict requirements for the plastics and their raw materials used here, because the active ingredients are directly given to patients

these strict regulations also force people to reflect on the material manufacturers, who produce high-performance polymers, such as medical technology application products isolated from other industrial grade products. Ticona is a pioneer of Polyoxymethylene (POM) copolymers. In 2005, the company introduced a new production line for its medical grade POM, which is supplied under the name of Hostaform Mt. So far, this production line is the only one of its kind anywhere in the world

high purity POM from the special production line

the special production line of medical Hostaform is proud of the significantly improved production conditions. This ensures that various materials have a high level of purity, making them directly traceable to raw materials and additives. The first important thing here is the production workshop. Walls and floors can be easily cleaned, thus creating a high level of cleanliness. There is no risk that raw materials or products will be polluted by dust, because raw materials will not directly contact the environment in any step of the production process. People have also focused on obtaining an ideal gas supply into and out of the extruder and isolating the gas from the environment These Measures mean that the production conditions are in line with the requirements of the pharmaceutical industry

maximum standard and long-term traceability

the second pillar of this new production line is the original computer-based quality management system, which monitors the whole production process, from feeding, to raw material formulation and mixing, directly 3 Put the pendulum on the edge of the support with wood blocks until storage and distribution

in Ticona, all raw material components introduced into the production process are marked with bar codes and electronic registration. The purpose is to obtain indistinguishable data, which is permanently recorded in the formula management database. Regular quality control is also completed during the production process and before transportation. In response to the change of its proliferation, samples were taken from each batch and analyzed, using standard procedures and other methods used in the pharmaceutical industry

industry screening criteria: top quality and highest safety

when selecting a suitable material for the medical transmission system, both manufacturers and the medical and pharmaceutical industry strive to obtain the best mechanical and technological performance. The decisive criterion for the development and selection of "right" plastics is that there should be no migration of ingredients from materials to pharmaceutical products, or at least only the minimum amount allowed. This ensures the stability of the product and prevents any possible toxicity to patients

omnipotent for medical applications: POM for packaging

Ticona now supplies 10 different MT level POM products, which not only provides a wide range of options, but also takes 6 ⑴ 2 hours to choose through the exchange of electric slow charging, and is mature in specific application fields. Today's medical technology is unimaginable without the specific performance of these products. In addition to high purity, these properties also include biocompatibility, disinfection, corrosion resistance, chemical resistance and first-class mechanical properties, such as excellent dimensional stability, good surface smoothness, investment attraction at the same time, toughness and a high level of hardness

these specific properties promote the development of innovative transmission systems, which play a key role in improving the often insufficient or inconvenient medication. An example is the treatment of asthma. In addition to high levels of purity and disinfectability, other specifications used in the formulation mechanism of dry powder inhalers include absolute dimensional stability and good surface sliding performance (Title figure and Figure 4) POM can also be used in the valve of aerosol inhaler, which can realize the accurate quantitative supply of active ingredients through the necessary droplet distribution, so as to achieve the desired effect

hostaform products also contribute to the accurate feeding of insulin injection pens. The accuracy is a fraction of the size of droplets, ensuring that the injection pens have consistent applicability for many years. It is the good toughness and hardness that make POM a suitable material for disposable insulin syringes. In another innovative injection device, drugs such as anti influenza active ingredients are no longer injected through a needle, but "shot" under high pressure to the cortex

prospects for future development

the common feature of all medical applications is that in the preparatory stage before their introduction, they have gone through the comprehensive and complex certification process necessary for medical products. Decisions made at this stage will usually remain fixed throughout the life of the product. Once a material is used in the development of a medical device and the key research on its safety, compatibility and efficacy has been completed, it is very expensive or even impossible to change the specification. This makes it most important to include all parties including suppliers in every stage of the development process, so that the expensive process will not be harmed. This requires open and sincere cooperation between all interested parties throughout the service life of the product under discussion. On the other hand, patients will benefit from using a simple and safe transmission system

reprinted from: pharmaceutical packaging