The ISO 11607:2006 standard regulates sterile barrier and packaging systems. It is intended for the medical industry, healthcare facilities, and wherever medical devices are placed in sterile packages and sterilized. The standard has been developed to protect patients by ensuring sterility and defining the role of responsible material suppliers.

The standard's two parts outline requirements for terminally sterilized medical devices. Part 1 (ISO 11607-1) describes requirements for materials, sterile-barrier systems, and packaging systems. Part 2 (ISO 11607-2) outlines validation requirements for secondary operations such as cutting and sealing. Companies may also use European standard EN868-2 to EN868-10 to show compliance with the ISO standard.

Part 1 describes tasks which must be carried out within a formal quality system. For example, sampling plans for selecting and testing packaging systems are required and must be statistically valid. Part 1 also lays out requirements and test methods for materials, preformed and other sterile barriers, and package designs intended to maintain sterility of terminally sterilized devices until the point-of-use.

The standard, however, does not cover all requirements for sterile barriers and packaging systems for aseptically manufactured devices. It is also not intended to describe a quality-assurance system that controls all manufacturing stages. Additional requirements may be needed for combination products (devices with drugs).

Part 2 specifies requirements for developing and validating operations that package medical devices. These include forming, sealing, and assembling for packages, sterile barriers, and preformed sterile barriers.

Raw-material suppliers are subject only to certain portions of ISO 11607. For example, Eastman supplies Eastar copolyester 6763 resin, a material used in rigid packages, but the company does not extrude, form, seal, or assemble final sterile barriers. However, raw-material suppliers can help medical industry partners comply with ISO requirements by providing a range of information, such as:

Physical properties. Material selection is an integral component of ISO 11607 and raw-material suppliers must provide relevant information to support a device manufacturer's product lifecycle. First, suppliers should provide information on physical properties relevant to the device's intended use. For instance, our company helps with package design by providing data sheets with typical mechanical properties (modulus, impact resistance, tensile strength), thermal characteristics (glass transition, specific heat), barrier conditions (moisture vapor-transmission rates), optical properties (haze and gloss), and oxygen permeability.

Quality assurance from raw-material suppliers comes in forms such as traceability as it appears in ISO 11607 section 4.5 and 5.1.4. Suppliers should be able to trace all pertinent data for incoming raw materials, manufacturing processes, handling, storage, and shipment for each production lot, as documented in an ISO 9001:2000-registered quality system.

Other elements of a corporate quality-assurance program include customer notification of changes, control of nonconforming material, and effective complaint handling. Other tasks in a QA program detail requirements for internal audits, specifications, and test methods. Plans should be in place to prevent contamination, including pest control, maintenance, and facility-housekeeping. Appropriate material handling methods are also followed to prevent contamination from other products and external sources. Finally, responsible suppliers ensure consistent process control during manufacturing, and strive for continuous improvement.

Biocompatibility and toxicological testing of the material must be documented after sterilization, as outlined in the standard's section 5.1.5.B.

Secondary operations should be evaluated for compatibility with a material. ISO 11607 sections that apply to material manufacturers include Thermoforming/Cutting/ Sealing (section 5.1.5.D) and Sterilization (section 5.1.5.E). A good medical-packaging team will have tested how well its materials extrude, thermoform, cut, seal, and perform in other secondary operations for sheet and trays, as well as provide general guidelines and advice to users.

Compatibility with sterilization refers to knowing the effect of the sterilization methods on physical properties of the material to evaluate the suitability of a sterilization processes for a material (section 5.1.5.E). Technical information on sterilization performance is available to assist device manufacturers with their compliance documentation.

Shelf Life Limitations refers to changes that might occur to the material and restrict use when stored in different environments as described in section 5.1.5.F. Material suppliers should test its materials to provide data on shelf life. Accelerated aging has also been done on rigid medical packages manufactured to the ISO standard.

APPLYING ISO 11607

As a material supplier of Eastar copolyester 6763 for medical packages, Eastman has developed supporting information needed by customers to comply with ISO 11607. The material has been tested after sterilization and meets ISO 10993 and USP Class VI biocompatibility requirements. Also, testing revealed no physical property deterioration after exposure to EtO, gamma irradiation, and E-beam irradiation.

Eastman's medical-packaging team has tested the material for thermoforming, sealing, cutting, and other secondary operations for sheet and trays, and provide guidelines and advice to users. For instance, tests show that following good design, manufacturing, and storage practices, lets the material provide package integrity for at least five years. To support qualification and compliance with ISO 11607, Eastman has developed a compliance document available at www.Eastman.com/medical.