MEDICAL DIVISION
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MEDICAL DIVISION:
Röchling Manufactures Vials in ISO Class 5 Clean Rooms Using a Two-Component Injection-Molding Procedure

The clue is in the name: Aseptic Technologies supplies the pharmaceutical industry with equipment that ensures medications are bottled aseptically. The plastic ampules needed for filling, known as vials, will be produced and supplied by Röchling Medical in the future.

Aseptic Technologies was founded in 2002 and is based in Belgium. The company has now awarded a contract to Röchling Medical for the first time. Even if the contact is still new, a phase of intensive mutual acquaintance and understanding over the past few months has already led to close and trusting collaboration. “Customer employees visited us several times in Brensbach, Germany, observed our production, our processes and our systems and got to know the employees who will be involved in this project in the future,” reports Marco Vey, Deputy Project Manager of Röchling Medical Europe.

In the future, vials, which will later be filled with liquid medication by the pharmaceutical industry, will be produced for Aseptic Technologies in Brensbach. The vials are made up of four parts: a container for the active ingredients, a stopper that seals the container and two plastic rings that surround the container at the top and the base, known as the top and bottom rings. In clean room conditions in Brensbach, the vials are injection molded, closed straightaway and then delivered to Aseptic Technologies. From there, the vials are supplied to the pharmaceutical manufacturers, who use gamma radiation to sterilize them before they are filled. Aseptic Technologies has developed a special system for this. A special needle pierces the stopper, allowing the liquid medicine to be injected into the vial. A laser is used to immediately reseal the puncture site in the stopper. The contents of the vial will be removed in clinics or medical practices using a syringe, which pierces the stopper, and then injected into the patient.

New Process, New Clean Room Class
Producing vials under clean room conditions is, in principle, nothing new for Röchling Medical Europe. However, the plastic specialists are entering new territory with the manufacturing process for Aseptic Technologies. The vials will not be made with injection blow molding, but will instead be manufactured using a two-component injection molding assembly process in an ISO class 5 clean room. “The manufacturing process and this category of clean room are new to us. We are currently preparing meticulously and will master the new challenges professionally,” says Project Manager Vey.

Two-component injection molding assembly process means that two parts made from different materials are produced in just one tool. In this case, the active ingredient container is made from a transparent cyclic olefin copolymer (COC) and the stopper is made from thermoplastic elastomer (TPE). Two robots remove the finished parts from the tool cavities and then join them together. This process takes place entirely under ISO 5 clean room conditions, preventing the vials from being contaminated. Scratches, spots and increased tensions in the transparent copolymer must be prevented at all costs. Therefore, the very scratch-sensitive COC parts must be handled as so with kid gloves throughout the entire production process and be held by the robots only in the outer sections. “In order to avoid surface irritations, our tool cavities must also have a particularly high-quality surface finish,” explains Project Manager Vey. Each individual vial will also be turned 360° and subjected to a reflected and transmitted light inspection with a camera system, reports the 39-year-old.

High-Strength and Shatter-Proof
Vials made from engineering plastic have a crucial advantage over glass vials: the high-strength and shatter-proof material prevents the vials from being broken if they fall accidentally when in use. At the same time, the plastic has very good barrier properties, like glass. This means that liquids or gases cannot pass through it. In addition, thanks to their special design and material properties, the vials can be stored by pharmaceutical and healthcare companies and establishments in liquid nitrogen without jeopardizing the integrity of the container closure. The vials will be manufactured for Aseptic Technologies in three sizes. The “normal” vials hold a milliliter or two milliliters and a special version is suitable for less than one milliliter. It has a v-shaped base, which makes it possible to remove even the smallest remaining volume with the syringe. This is because the medications, particularly those used in oncological treatment, are very expensive and this complete emptying is an important factor.

During the production process, no-one is allowed into the clean room. All of the steps are fully automated. If tools need to be replaced or other tasks carried out on the equipment, the most stringent hygiene standards apply to enter and leave the clean room. “For the first time, we are manufacturing in an ISO class 5 clean room. We have given our employees relevant training and demand a high level of discipline, which ensures that all our processes meet the very high requirements, and monitor it all with the appropriate monitoring systems,” says Joachim Lehmann, Director of the Medical Europe Business Unit. The packaging process, including sterile shrink-wrapping of the vials, is regulated precisely.

At Röchling Medical, a large team works on setting up the perfect processes. This involves employees from the Purchasing, Quality, Tool Manufacturing, Production and Technical Services for Plant Planning departments. Every two weeks, there are regular telephone conferences with the customer to coordinate the project status. In addition to this, there are meetings at the Brensbach location or in Belgium. For Aseptic Technologies, a smooth start to the project is important in order to be able to supply pharmaceutical companies reliably, as normal. They are on the right track together with Röchling Medical.