Pre-filled sterile syringe: plastic instead of glass

Although glass has existed as a packaging material for pharmaceuticals for a long time, it is not the only choice. A high-tech plastic and new design are establishing a new standard in accuracy, drug compatibility, and barrier properties in the pharmaceutical packaging field.

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

New solutions for drug release and diagnosis

Klaus Holtzhauer, Dr. Klaus Holtzhauer, Manager of Syringe Production at Schott forma vitrum, explains that glass-like containers made of plastic provide a novel solution for drug release and diagnosis. They are establishing a new standard in precision, drug compatibility and barrier properties in the pharmaceutical packaging field. Transparent TopPac plastic containers are a good alternative to pharmaceutical packaging made from borosilicate glass.

Glass is considered a good packaging material for injectable drugs. However, in some cases, glass is not the best choice. For example, in first-aid drugs that are at risk of fracture. The market's needs are constantly changing. The pharmaceutical industry is constantly developing new types of drugs, and therefore new types of packaging are also needed. This puts forward newer and stricter requirements for pharmaceutical industry containers. Better compatibility, safe handling of toxic products, active ingredients, longer life, ease of packaging, and innovation are new challenges facing the pharmaceutical packaging industry. Schott has worked closely with pharmaceutical companies to jointly develop new containers to meet the needs of industry and users.
Dr. Holtzhauer knows that the market for injecting drugs is growing rapidly, in part because of developments in areas such as vaccines, heart medicines and cosmetics, medical imaging, self-care and emergency medical services. As a result, the demand for safe, user-friendly pharmaceutical packaging has grown substantially, especially for syringes that can be used directly.

Advantages in different fields

TopPac has many advantages in the following areas:
* Suitable for solvents such as water and protein products for injection and high viscosity formulations.

* It can meet the stringent industry requirements for the direct application of the syringe, and can ensure that the drug does not come into contact with the environment and does not react with the drug at the same time.

* Vials and syringes made from TopPac can be stored in small sizes for many years because of its excellent barrier to water vapor.

The syringe model ranged from 1 ml to 50 ml, but the advantage was more pronounced in the range of 1 ml to 10 ml. 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 containers are produced in the clean room through the injection molding process, they are packaged directly in sterile form, sterilized and delivered directly to the customer's clean room. The complete syringe equipment includes rubber components that all well-known manufacturers can provide. Last year, TopPac syringes that could be used directly were introduced into Europe for emergency treatment of heart patients. Specific studies began at the Otto Schott Research Center in Marienborn in the late 1990s.

Production according to cGMP rules

The current production of this product is mainly carried out in Schott, Switzerland. The company was established for the production of this product and has passed ISO 9001:2000 and ISO
13485 (medical product) certification. The syringes are manufactured in accordance with cGMP regulations and meet the standards of the pharmaceutical industry in Europe, Japan and the United States.

Holzhauer told us that in order to achieve the quality standards of the products that are directly used, they strictly inspected the entire production process from the moment the 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 test and control all the production process parameters, including the application of remote control cameras to adjust the fully automated 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 the aseptic production equipment developed by Schott Polymers. Thanks to modern aseptic production techniques and corresponding injection molding equipment, bacteria and non-microparticle conditions are still well controlled after opening the molding equipment. The syringe is packaged with optimized protection equipment and radiation sterilization. The pharmaceutical company is responsible for the pharmaceutical solution being filled into the syringe under aseptic conditions. The company received TopPac's direct-use syringe from Schott Polymers and sent it directly to the aseptic 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 compelling as it is now. This is the case for packaging in the pharmaceutical industry, for example. The packaging must be able to effectively protect the drug, meet stringent industry standards and at the same time be free from problems during drug delivery, while also cutting 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 (cycloolefin copolymer). The COC polymer chain contains two different monomers compared to most other common polymers used in packaging. The basic ingredients of Topas are ethylene and norbornene. By changing the proportion of norbornene, the properties of the material can be varied over a wide range to meet the needs of certain special applications. For example, changes in physical and chemical properties can make Topas suitable for storage of pharmaceutical products. In addition to reducing weight, improving tear resistance and transparency comparable to glass, barrier properties and chemical stability are excellent. At the same time, this material has good inertness, low absorption rate, no ions on the surface, and no release of heavy metals. Topas also has some flexibility in the design and sterilization process. In addition to pharmaceutical packaging, other uses for this material include:
* Blister packs for pharmaceutical and other cosmetics;
* Diagnostic applications, such as microtiter devices, micro-instrumentation devices, micropump devices, microfluidic molecules, micromixers, cuvettes, and micro-structured chips;
* Flexible packaging film;
* paper/cardboard coating;
* Optical applications such as lenses, prisms, inductors, fibers and films;
* High frequency applications
* Toning resin (powder) for color printers;
The development of Topas
* 50 years: Cycloene was used as the initial polymerization experiment;
* 1990: COC project started at what was then called Hoechst AG polymer research center;
* 1993: Initiated research and development cooperation with Japan's Mitsui Petrochemical Company for continuous production process;
* 1995: Semi-commercialization of the first production line;
* 1996: To build a new Topas production line in Ticona to develop Hoechst norbornene production process;
* 1998: choose to establish a production base in Oberhausen;
* 2000: Topas COC production line with annual output of 30,000 tons put into use;
* 2004: Today, Topas has been used in more than 50 areas around the world;