Manufacture of components for medical devices: Parenteral nutrition bag handle.

What is parenteral nutrition?

Parenteral nutrition is a method of feeding that is used when a person is unable to obtain necessary nutrients through the digestive system. 

This may be due to a variety of reasons, such as gastrointestinal diseases, surgeries, or conditions that prevent oral intake.

Types of Parenteral Nutrition

1. Total Parenteral Nutrition (TPN): This type of nutrition provides all essential nutrients, including carbohydrates, proteins, fats, vitamins, and minerals. It is administered through a central vein, which allows for the infusion of concentrated solutions.
2. Partial Parenteral Nutrition: In this case, only some specific nutrients are supplied, while the patient may continue to receive some food by oral or enteral route.

Parenteral nutrition bags

Parenteral nutrition bags are essential medical devices for the delivery of nutrients directly into the bloodstream of patients who are unable to take oral or enteral feedings. 

These bags contain a balanced mixture of nutrients and are used in the context of total parenteral nutrition (TPN) or partial parenteral nutrition.

Characteristics of Parenteral Nutrition Bags

• Material: They are usually made of a flexible and transparent material, which allows viewing of the contents and facilitates handling.
• Sterile: These bags are sterile to prevent infection. 
• Capacity: They usually come in different volumes.
• Closure system: Many bags have a closure system that allows administration through an infusion system, which facilitates flow control.

OSF: Manufacture of the handle for the parenteral nutrition bag

With our contract manufacturing service at OSFplastic we have provided a plastic injection moulding solution for the parenteral bag handle from conceptual design through to final product manufacture and packaging:

1. Collaborative design: Advice and collaboration in the design of the component, taking into account the functionality, strength and aesthetic requirements requested by our client.
2. Advice on materials: With our experience and with the collaboration of our suppliers, we support the selection of the most suitable material for the needs of the component.
3. Manufacture of the series mould: Construction of the mould and manufacture of first samples of the component for its validation.
4. Series production validation: Internal and customer approval of the series production process and components. 
5. Packaging of the component: Selection of the most suitable packaging for the preservation of the component until delivery to the customer.

Manufacture in the ISO 7 certified Clean Room 

The manufacture, handling and packaging of the components is carried out in the Clean Room with ISO 7 classification to guarantee sterile conditions and avoid contamination.

The technology that makes this possible is a 30Tn injection moulding machine, also located in the Clean Room.

The material chosen for the device is a medical grade biocompatible thermoplastic, guaranteeing its quality and safety for use in patients.

ISO 13485 provides manufacturers of medical devices and related services such as OSF to increase their access to international markets, thereby demonstrating their compliance with regulatory requirements and customer expectations.