Single-cavity mold for production of drug caps

Smiths Pharmaceuticals supplies a variety of health-care devices and equipment, including hospital-specific equipment and equipment used in the community's daily care. Its solutions include: pain care products, needles and safe blood collection products, temperature management, diabetes treatment, injection therapy, assisted reproduction and patient monitoring.
According to the company's statement, the goal is "to consistently deliver on the basis of performance requirements, to make the product value, safety, and confidence." "In the past three years, Smiths has kept its promise in the field of insulin pump treatment for diabetes and succeeded. The Cozmore insulin technology system has been introduced to the market and has reached a high level of technology.” Cleo 90 is the latest innovation.
An indispensable part of the precision injection device Cleo 90 is the needle delivery system, which consists of a small plastic cartridge. This small plastic cartridge was sealed with a cap manufactured by Precise Technology. This kind of lid is strong and can be tightened, loosened and protected. According to Mark Faust, Senior Project Manager at Smiths, prior to providing Precise with cover plans, physical models and design requirements, they conducted extensive market research for users, and Precise provided proprietary technology and mold design.
The injection device is the heart of any insulin pump system. The injection device consists of flexible tubing, which is connected to the pump. Through the pump, the desired insulin preparation is delivered. At the end of the tubing is a soft needle or cannula that can be buried under the skin of the abdomen, thigh, or buttock with an insertion needle. After the introduction needle is removed, only the cannula remains in place. According to the guidelines provided by the manufacturer according to the FDA directive, injection devices are usually replaced every 2 to 3 days.
The Cleo90 injection device was developed by Smiths to address the convenience, flexibility, and safety issues of existing products on the market. Other similar injection device products consist of multiple components, which are individually packaged in thin film pouches and require some skill when inserted. The Cleo 90 is an all-in-one, easy-to-handle system that consists of a small tube with an automated needle safety system, skin-like adhesive wraps, and a hidden insertion pin for ease of operation.
Precise Technology is the supplier of strong sealed cans. Its health products account manager Robert Fesus explained: "Smiths' goal is to have a ready-to-use product. The strong lid is its main component."

Smiths’ goal is to have a "ready-to-use" product.
The key to this system is the lid, because there must be a protective device.

While designing single-cavity molds this year to commemorate its 40th anniversary, Precise Technology has grown to be one of the largest contract injection molders in the United States, with 15 points in the United States and 1 point in Europe, with a total of more than 425 units in operation. Injection molding machine. The company's four main areas are: healthcare, consumer packaging, personal care, and food and beverage applications.
For Smiths, the Cleo 90 cartridge and closure deviated from the history of traditional film packaging for injections. They fully understand the purpose of this packaging, so they rely on Precise to help them achieve these goals. When designing a package, it cannot be seen at a glance. It is a medical device because it is used outside the hospital.
Gary Berge, senior product design engineer at Precise, said that the biggest difficulty is that it is strong and easy to open.
According to Kurt Attermeier, vice president of research and development at Precise, Smiths' other design requirements include: easy assembly, microbiological blocking measures, and compatibility with various sterilization methods.
Precise’s Illinois campus has an 83,000-square-foot mold-making shop that uses CNC (computer numerical control), EDM (electromachining), and hard-grinding technologies to create high-tolerance, high- and low-cavity production molds. Grassel said that after the acquisition of Courtesy, Precise invested $1 million in the rectification of the working environment, modernized the production process, and purchased new equipment, including the Mikron HSM 800 high-speed grinding machine.
In the factory, FasTrack's rapid tooling program was used to create key models that needed to be rushed out as soon as possible. At the center of the 8,000-square-foot mold shop is the FasTrack production area. This area is FasTrack equipment, operators have been cross-training, and can operate at least two or three different devices.
As far as the Cleo90 seal is concerned, the originally produced parts did not meet all the functional requirements in the Smiths test. Smiths had to go back to repaint the board and suggested several design and moldmaking solutions to Precise. The recommendation to Precise is to be able to pull the undercut and use special cooling methods in the process. Precise brought these suggestions to Gary Berge and asked him to design a tool and integrate Smiths' ideas.
The final lid design uses a central "pillar" to protect the needle and includes several tabs that can be placed inside the internal thread. The outside of the lid and the tear strip use ribs to properly position the lid during assembly. In addition, the lid also uses a unique design of the clogging zone, which is completed by a precision-made connecting bridge, which is necessary to ensure that the belt can be reliably separated.
The design of the sealing tape is one of the core capabilities of Precise, which is another factor that attracts Smiths to the door. Fesus said that because of his confidence in Precise's skills, Smiths decided not to conduct on-site investigations of the Precise plant or monitor its development process. He said: "This is another reason why they have come to us. They trust our experience in precision sealing and we have gained their trust."

Precise's 83,000-square-foot moldmaking shop uses CNC,
EDM and sturdy grinding technology to produce high tolerance, high and low cavity molds.

Confirming Materials and Processes In terms of material selection, Precise and Smiths selected Dow Chemical's high-melt-point high-density polyethylene resin.
After completing the single-cavity sample mold, Precise began to confirm the process and materials, and produced seals for FDA inspection and Smiths marketing use.
Precise's medical modeling and equipment assembly operations were conducted in a 101,000 square foot controlled environment workshop. The workshop has 38 injection molding machines with capacity from 55 to 550 tons, and some also have robots. On the PD visit, Precise was producing Smiths' single-cavity mold product on a 65-ton Krauss Maffei injection molding machine. Fesus said that when the multi-cavity mold is ready, the seal will be produced on a 165-ton machine.

Precise used a single-cavity mold to make caps on a 65-ton injection molding machine.

Precise is proud of its comprehensive verification testing program. With this process, Fesus said that in many cases customers do not have to test the product. He explained: "The key to having a validation process is that when you work in the front end, or if you have troubleshooting and proper debugging of the mold, and established a variety of cycles to try to meet the requirements of the key dimensions, you will Statistical analysis can be used to ensure that all products are qualified."
For Smiths, Precise's comprehensive validation services and its multifaceted capabilities have enabled the company to produce a unique drug delivery system for people with diabetes. In October 2004, Cleo 90 received FDA marketing approval. It was also at this time that Faust of Smiths told PD that national marketing campaigns and customer forums received “very positive” feedback. (Packaging Digest Author: Senior Editor Anne Marie Mohan)