Packaging medical devices

FDA of its intent to market the product, but need not wait for FDA approval. Class in devices require the same general type of premarket approval as drugs, including approval of the packaging. The new device regulation has become more overtly a process control regulation, and specifies that the package is a component of the device. 

---

Approved packaging is normally selected after completing package performance qualification testing as well as product compatibility and stability studies. Since in most cases (exceptions transdermal delivery systems, diagnostic tests, and medical devices) packaging is not intimately involved in the manufacturing process of the product itself, it differs from other factors, such as raw materials. 

When the development and validation of the packaging manufacturing process are completed, the standard testing procedures (e.g., ASTM) should be used to ensure sterile medical device package integrity and the sterility of the product after additional production processes. 

The relationship between accelerated aging and real-time aging for packages has not been determined, and although the theory states that for every 10°C rise in temperature the reaction rate of material doubles, this should be applied with some caution for such materials as medical devices packaging. 

The overall protocol for packaging validation remains the same whether microbial challenge test methods or physical test methods are used. At each stage in the development and production process of a package for a medical device package integrity must be verified. 

O Brien, J. D. (1990), Medical Device Packaging Handbook, Marcel Dekker, New York. 

Biopolymers Lanthan, dextran, polyhydroxybutyrate Food additives, medical devices, packaging... 

Vermillion, R. J., 2008, Considering static control for electrostatic discharge-sensitive medical device packaging, Pharm. Med. Packaging News 16(2) 54-62 (February). 

ASTM F 1980-02. 2002. Standard guide for accelerated aging of sterile medical device packages. West Conshohocken, PA American Society for Testing and Materials. 

The materials most commonly used for medical device packages today incorporate the characteristics required for a protective package. 

The medical device industry uses a limited variety of types but many different materials in each form. Over the past 20 years, the industry has standardized on the following basic medical device package types. 

This part provides a basic overview of some of the more common packaging materials used for medical device packages. Since entire books are published describing the chemical characteristics, applications, and performance properties of packaging materials, it is beyond the scope of this chapter to provide all of the necessary information for the selection of materials for the specific medical device. Consult the references for additional information. 

Paper. For many years, paper was the only choice for package types until the introduction of Tyvek as a medical packaging material. However, paper still plays a significant role in the medical device industry. Over the years before the introduction of Tyvek, paper materials compiled a significant performance record of product protection and patient safety. Although Tyvek has taken a majority share of the medical device package market, the industry is finding ways to utilize paper in combination with plastics and foils to provide the needed performance characteristics with favorable economics. 

Some of the limitations of paper as a medical device packaging material are ... 

Films, Laminates, and Coextrusions. Many films are used in medical device packaging applications. Both flexible formed and nonformed pouches, as well as bags, use films for their manufacture. These materials offer a high degree of versatility and are available in a countless variety of forms in monofilms, laminations, and coextrusions. The specific material to be used for a medical device is dependent upon the performance properties required for the device application. For example ... 

The flexible materials used for medical device packages include a plastic film that is usually a lamination or extrusion-coated material. The material most commonly used for flexible packaging applications is oriented polyester (e.g.. Mylar ), which is used as a base for properties such as dimensional stability, heat resistance, and strength with an adhesively laminated se layer such as low-density polyethylene, which provides the film structure with heat sealability. The variety of film combinations is virtually unlimited and the performance properties of the film can be customized to meet the requirements of the package specifications and the medical device. Other examples of film constructions are... 

---