The hottest pre filled sterile syringe uses plasti

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Pre filled sterile syringes: replace glass with plastic

although glass has been used as a packaging material for drugs for a long time, it is not the only choice. A high-tech plastic and new design are establishing a new standard in the accuracy, drug compatibility and barrier performance of pharmaceutical packaging

schott forma Vitrum is the world's leading packaging manufacturer in the pharmaceutical industry. The company has developed a new generation of high-tech plastics. Toppac brand includes a series of syringes and vial products, which combine Schott's advantages in production and design with the superior performance of cycloolefin copolymer Topas from Ticona. At the end of April this year, at an international conference in Oberhausen, this new polymer and its application prospects were shown

new solutions for drug release and diagnosis

KLA, the syringe production manager of Schott forma Vitrum, bridges with peroxides. Dr. us holtzhauer explained that glass like containers made of plastic provide a new solution for drug release and diagnosis. They are establishing a new standard in the field of precision, drug compatibility and barrier performance in pharmaceutical packaging. Transparent toppac plastic containers are a good alternative to pharmaceutical packaging made of borosilicate glass

glass is considered as a good packaging material for injectable drugs. However, in some cases, glass is not the best choice. For example, in the first-aid drugs with crushing risk. The market demand is constantly changing, and the pharmaceutical industry is also constantly developing new drugs, so new packaging is needed. This puts forward newer and stricter requirements for containers in the pharmaceutical industry. Better compatibility, safe treatment of toxic products, active ingredients, longer service life, simplicity and innovation of packaging are new challenges facing the pharmaceutical packaging industry. Schott has worked closely with pharmaceutical manufacturers to develop new containers to meet the needs of industry and users

Dr. holtzhauer is well aware that the market for injectable drugs is growing rapidly, partly due to the development of vaccines, cardiac drugs, cosmetics, medical imaging, self-care and emergency medical services. As a result, the demand for safe and user-friendly drug packaging has increased significantly, especially for syringes that can be directly used

advantages in different fields

toppac has many advantages in the following fields:

* suitable for solvents, for example, water for injection, protein products and high viscosity prescriptions

* it can meet the strict industry requirements for direct application of syringes, and ensure that drugs do not come into contact with the environment and do not react with drugs at the same time

* vials and syringes prepared by toppac can be stored for many years in a very small size, because this material has excellent barrier to water vapor

the models of syringes vary from 1ml to 50ml, but the advantages are obvious in the range of 1ml to 10ml. Because the material is very flexible, Schott can provide many special properties, such as the integrated luer lock. Toppac products can be applied directly. After the container is produced in the clean room by the hydraulic clamping technology through the clamping method of the injection molding worker's jaw, it is directly packed in a sterile form, sterilized and directly transported to the customer's clean room. The complete syringe equipment includes rubber components available from all well-known manufacturers. Last year, toppac syringes, which can be used directly, were introduced into Europe for emergency treatment of heart disease patients. Specific research began in the Otto Schott research center in marienborn in the late 1990s

it is produced according to cGMP rules

at present, the production of this product is mainly carried out in Schott, Switzerland. The company is established for the production of this product, and has passed the certification of ISO 9001:2000 and ISO 13485 (medical products). Syringes are produced according to cGMP rules and meet the standards of the pharmaceutical industry in Europe, Japan and the United States

holzhauer told us that in order to meet the quality standards of directly used products, they strictly checked the whole production process from the moment COC polymer was transported to the factory. The material is transferred directly to the injection molding equipment. In the production process of the clean room, they detect and control all the production process parameters, including the use of remote-control cameras to adjust the automatic production line to ensure high product quality

toppac syringes avoid processes that waste cost and time, such as cleaning and sterilization. These cost advantages come from sterile production equipment developed by Schott polymers. Due to modern aseptic production technology and corresponding injection molding equipment, bacteria and particle free conditions are still well controlled after opening the molding equipment. Syringes are packaged by optimizing the protective equipment of the organization and radiation sterilization. The pharmaceutical company is responsible for loading the drug solution into the syringe under sterile conditions. The company receives the syringe directly used by toppac from Schott polymer company and sends it directly to the sterile factory, so it does not need to be cleaned or sterilized again

Topas COC high-tech polymer - another material

without high-performance polymers, the development of innovative applications in the medical field will not be as eye-catching as it is now. For example, packaging in the pharmaceutical industry is like this. Packaging must be able to effectively protect drugs, meet strict industry standards, and at the same time, there should be no problems in the drug delivery process, while reducing costs and satisfying customers. In order to meet these demanding requirements, Ticona has developed a special polymer, including Topas COC

two different monomers

Topas plastic from Ticona is a high-purity COC polymer (cycloene copolymer). Compared with most other ordinary polymers used in packaging, COC polymer chains contain two different monomers. The basic components of Topas are ethylene and norbornene. By changing the proportion of norbornene, the properties of materials can be changed in a wide range to meet the needs of some special applications. For example, changes in physical and chemical properties can make Topas suitable for the storage of pharmaceutical products. In addition to reducing weight, improving tear resistance and transparency comparable to glass, the barrier performance and chemical stability are also excellent. At the same time, this material has good inertia, low absorption rate, and no ions on the surface will not release heavy metals. Topas also has certain flexibility in the design and sterilization process. In addition to pharmaceutical packaging, other uses of this material include:

* blister packaging for pharmaceuticals and other cosmetics

* diagnostic applications, such as microtitration equipment, microtest equipment, micropump equipment, microfluidic molecules, micromixers, small test tubes, and microstructure chips

* flexible packaging film

* paper/paperboard coating

* optical applications, such as lenses, prisms, sensors, optical fibers and films

* high frequency application

* color matching resin (powder) for color printer application

development track of Topas

* 1950s: cycloene was used for the initial polymerization experimental research

* 1990: the COC project was started at the place then known as the Hoechst Ag polymer research center


1993: started research and development cooperation with Mitsui Petrochemical Company of Japan to try continuous production process

* 1995: the first production line was semi commercialized

* 1996: build a new Topas production line in Ticona and develop Hoechst norbornene production process

* 1998: choose to establish a production base in Oberhausen

* 200 but it is gratifying that 0 year: the Topas COC production line with an annual output of 30000 tons has been put into use

* 2004: today, Topas has been applied in more than 50 fields around the world

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