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Top Healthcare-Related Material Considerations for Combination Products

Tue, 05/08/2007 - 11:31am

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For manufacturers of combination products, avoiding potential pitfalls is significantly more complex than with traditional medical devices due to the inclusion of a drug or biologic element. Therefore, companies need to ensure they have addressed concerns early in the material selection process. This article highlights four critical considerations for companies selecting materials for a combination device.

By Clare Frissora
Combination products have captured the attention of the healthcare industry. Comprising two or more regulated medical products—often a drug, biologic, and/or device—that are marketed as a single unit (or intended to be used together and labeled accordingly), they present opportunities to create new cardiovascular, drug delivery, and biotechnology solutions.

Bioject Biojector 2000 needle-free drug delivery injection device utilizes biocompatible and food contact compliant Lexan resin from GE Plastics for excellent clarity, impact strength, and durability.
The growth of combination products, together with the evolution of regulatory oversight, is driving the need for resin materials that support both performance and compliance needs. In the United States, the FDA’s Office of Combination Products (OCP) was created to help guide evaluations and the regulatory process for such products. Due to the range of possible drug/biologic/device product configurations, the OCP assigns the lead regulatory review of the product to an FDA agency based on the OCP’s assessment of the product’s primary mode of action. More than one agency may be involved in the review; as such, various regulatory aspects may be brought together for a specific product’s review. This has prompted some manufacturers to become familiar with pharmaceutical or device regulatory aspects that they may not have dealt with previously. In some cases, this has called for a broader range of material selection considerations.

Material considerations include the mechanical and physical performance needs of applications (for example, strength, stiffness, impact resistance, lubricity, chemical resistance) as well as other healthcare-related topics, including advanced material surfaces to reduce interactions between the drug or biologic and the device, biocompatibility, food contact compliance (FDA, EU), and product response to sterilization techniques. Following, these latter considerations are discussed.

As with all product development, engagement of the materials supplier early in the process helps avoid late changes or missed considerations.

Advanced Material Surfaces

In-vitro diagnostic, biopharmaceutical, or combination products that require protein contact with a plastic device or component may benefit from improved material capabilities such as low-adhesion or non-binding surfaces that help enable more protein to remain in the biologic. Similarly, blood management devices with advanced surfaces may reduce interaction between the blood and device, thus reducing impact on blood functionality.

A low-adhesion or non-binding surface may be achieved by coating plastics, but this approach typically requires secondary operations that may add time and cost. An alternative to employing this method is to use a material that offers the advanced surface as an inherent feature. Such materials can offer the typical strength of polycarbonate (PC) but have also been engineered to help reduce protein binding and improve hemocompatibility without applying a coating.

Biocompatibility

Many healthcare devices undergo specific safety evaluations, including biocompatibility, if they are intended for human body contact. The International Organization for Standardization (ISO) provides standards for the biological evaluation of medical devices (ISO 10993), which include tests and procedures dependent upon such factors as type and duration of body contact. As new combination products are developed, manufacturers may need to consider biocompatibility requirements due to the integration of drugs or biologics with devices. Companies should work with a materials supplier who can offer a full portfolio of biocompatible resins, thus facilitating a selection of materials that have been favorably assessed for biocompatibility.

Food Contact Compliance

Food contact compliance is often an important requirement for healthcare applications, including combination products involving a drug, biologic, or nutrient that will be introduced to the patient. Agencies such as the FDA, the European Food Safety Authority, and the EU Commission oversee regulation of food contact applications and materials. Therefore, before a material may be considered compliant, it must meet food contact regulations and standards. Importantly, there are differences in the regulations/legislation, so it is recommended to clarify the type of food contact required—for example, FDA, EU, or both—with the resin supplier.

Sterilization

The combination of drug, biologic, and/or device calls for careful consideration of the sterilization technique deployed since each element of the combination product may respond to various sterilization techniques differently. For example, ethylene oxide (EtO) sterilization of liquids is not typical; gamma irradiation of bio/pharmaceuticals is not typical; and not all resins are compatible with EtO, gamma, and steam autoclave. Therefore, when terminal sterilization is planned, the materials used to create packaging or devices must allow for the sterilization conditions of both the drug or biologic as well as the resin materials themselves, to enable retention of the mechanical and physical performance of the package or device after sterilization.

Conclusion

Combination products are a promising market for healthcare manufacturers. However, the complexity of these products together with increasing regulatory/legislative requirements mandate careful consideration of the materials used. Manufacturers need to evaluate the ability of a resin or compound to help meet requirements such as advanced surface properties, biocompatibility, and food contact compliance, as well as retention of properties following sterilization.

Lexan HPM resins demonstrate improved hemocompatibility vs standard polycarbonate across multiple biomarkers and test methods. Please contact GE Plastics for further information, if needed.
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For additional information on the technologies and products discussed in this article, visit GE Plastics at www.geplastics.com.
Clare Frissora is the market director of healthcare for GE Plastics. She is responsible for leading Plastics’ global healthcare initiatives and marketing team. Frissora can be reached at 413-448-6391 or clare.frissora@ge.com
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