With the continuing growth of the Medical Device Industry, the need for sterilizable packaging, barrier packaging and other packaging requirements for medical/surgical products, is increasing. With increased performance requirements, medical packaging converters and material suppliers are faced with challenges to provide products to satisfy these needs.

In order to understand the Medical Device Packaging markets , it is essential to have proper perspective for the industry broken down by product, material and market segmentation; exclusive value chain analysis by key areas, and a review of technology developments and new application opportunities.

The packaging industry is continuously evolving as medical product companies institute changes in the design, development, and manufacture of packaging systems.

It is essential to have an awareness of important packaging issues involving both design and manufacture.

It is also important to have a basic understanding of the importance of validating processes and equipment, and the continuing need to maintain control of established packaging processes.

The main objective is that the device package should protect the device during handling and shipping, and from the environment and microorganisms until the package is opened.

This includes allowing for any necessary sterilization. Packaging contains the product identification and other information Labeling. Packaging may also contain integral labeling and instructions for use. Finally, when the consumer is ready to use this product, the package should be easy to open without compromising the quality of the device. In the end, a well designed package facilitates use of the device and contributes substantially to the overall appeal of the product. It makes sense for the manufacturer to invest in the development of a safe, user friendly package.

PACKAGING DESIGN CONTROLS

Package design should be an integral part of the product development program. The total device and package system should be considered with respect to: device characteristics, sterilization process if any, sealing, labeling, secondary packaging, handling, shipping, environment, storage, federal regulations, and end use.

Defective packaging and seals have been a major cause of medical device recalls. This type of recall can often be avoided by correct package design including validation of the packaging and sealing processes.

It is important to be aware of the state-of-the-art in sealing methods and packaging materials, including their physical, chemical, biological, and compatibility characteristics and, of course, cost. "Wet" devices require high-barrier package materials and sealants with impermeability; resistance to solvents, grease, chemicals, and heat; and the ability to contain wetting agents, reagents, oils, or fragrances.

Design controls require that a packaging design undergo considerable validation, review, and documentation. However, the end result is a smooth transfer into production with increased package safety and efficacy, resulting in greater customer satisfaction and cost savings and reduced liability.

In addition to the GMP requirements, manufacturers should always study current packaging practices for products similar to theirs to determine current favorable practices and to prevent user packaging problems. For example, customary use may dictate the use of double primary packaging for some sterile devices. Finally, any packaging used for medical devices should satisfy the end user or customer requirements, which automatically satisfies one of the design GMP requirements. This is a key point to be considered during the design phase.

PACKAGING MATERIALS

Fulfilling the design control procedures discussed above should include using the most appropriate packaging materials available for the device.

Device packaging and shipping containers should be designed and constructed to protect the device from adulteration or damage during the customary conditions of processing, storage, handling, and distribution.

The package and device should be designed together so that all factors in the product and package system can be considered, such as device sharp edges and severe vacuum stresses. Some other factors to consider are:

It is important that sterile devices and their packaging material meet the requirements of the sterilization process, package sealing method, and intended use. For example, radiation sterilization may discolor packaging and sealing materials, or reduce their functional capabilities. All plastics are somewhat affected by radiation sterilization, occasionally positively, frequently negatively. Consideration should be given to the effect produced and the radiation dose needed to produce an effect. Complete storage and stability data should be compiled for sterile device packaging subjected to radiation or should be obtained from the supplier.

Ethylene oxide (EO) sterilization requires packaging material of sufficient porosity to allow air to leave the package and the gas to rapidly permeate the package, sterilize the product, and then leave the package. Adverse levels of EO residues left on the device harm the patient. Air washing at the end of the cycle reduces residues. Evacuation of the sterilization chamber for air removal, gas fill, and air washing can induce package stress, particularly when the cycle calls for high temperature, pressure, and rapid pressure changes before and after the gas exposure (dwell) period.