As a leader in medical device package testing, Keystone Compliance understands the importance of package sterility. Our knowledge of sterile barrier systems has allowed us to create a streamlined approach to package validation. We walk customers through the process from test plan to test report.
The remainder of this page speaks to the various components and considerations of medical device packages, specifically sterile barrier systems. If you need medical package testing, request a quote. If you are unsure of where to start, contact us. We look forward to working with you to help you certify your packages through our streamlined process.
Determining the Factors of Medical Device Packaging Design
When designing packaging for a medical device, numerous considerations must be made. For instance, the intended use and the transport method must be accounted for. The storage conditions, expiry date, and intended use are important. The final method of sterilization is also a key consideration.
It is important to identify these factors when determining the materials to be used for healthcare package compliance. Materials can have varying characteristics. In this case, the chemical composition of a material can limit the sterilization process that can be used. There are numerous sterilization methods available to package engineers.
Ethylene oxide is one sterilization method. In this method, the sterile barrier system allows the sterilization agents to enter. They effectively kill the microorganisms and escape without significant residual concentrations. Other sterilization methods that use the same process are moist heat and low-temperature oxidation.
Two other examples are gamma irradiation and electron beam. In these methods, a permeable component may not be required. In fact, the sterile barrier system can be made entirely of impermeable materials.
Overview of Sterile Barrier Systems
There are numerous forms of barrier systems. Although each has its unique qualities, most of them have similarities. For instance, most will have a top web and a bottom web. They also will have the means to join the two webs together. When a permeable seal is present, a sealant layer is applied to allow heat-sealing of the two layers together.
Examples of Sterile Barrier Systems
ISO-11607 spells out the details of eight sterile barrier systems below:
Preformed Rigid Tray with a Die-Cut Lid: These barriers are often used for heavy devices or devices with large profiles. Examples can include surgical kits, pacemakers, and orthopedic implants. From a construction standpoint, the tray is often performed by pressure-forming or thermoforming. The lid can be impermeable or porous. The die-cut lid usually has a sealant layer that heat-seals the lid to the tray.
Flexible Peel Pouch: Pouches are typically low profile and lightweight. They are usually constructed of a film on one side and either film, paper, or nonwoven on the other. Pouches are supplied as preformed sterile barrier systems with all of the seals formed except one. Due to their customization, pouches can accommodate devices of many sizes.
Sterilization Bag: A sterilization bag is constructed from a single web of porous medical-grade paper. This paper is folded to form a long tube with or without side gussets. The tube is sealed with a double line of adhesive. Sterilization bags are cut to the required size. The final closure of the bag must occur prior to the sterilization process.
Header Bag: Header bags are typically welded seal bags. They are fabricated from two permeable but compatible film webs. One of the heads is offset. Across the offset area, a permeable material, with adhesive, is heat-sealed. This material can be peeled to access the bag. Header bags are popular with bulky items, such as kits.
Form/Fill/Seal (FFS): FFS sterile barrier systems can look just like rigid trays with lids or pouches. They can also have a flexible film bottom web. In construction, the top and bottom web materials are placed on the FFS machine. The machine forms the bottom web, filling the form with the device. The top web is then applied and the barrier is sealed
Four-Side Sealing Process (4SS): The 4SS is a non-stop packaging process similar to a flow pack. 4SS is used predominantly for the packaging of gloves and wound care products. It employs rotary sealing equipment to form the seal. The product is placed on the bottom web. The top web is applied above it and all four sides are sealed.
Sterile Fluid Path Packaging Systems: These typically only apply to medical devices with sterile fluid paths. They can consist of covers, plugs, caps, and other device-specific closures.
Sterilization Wraps: Wraps are commonly used in health care facilities. The wrapping and folding process provides a difficult path that maintains sterility. Devices are usually placed in instrument trays prior to wrapping and sterilization.
As previously mentioned, there are other forms of sterile barrier systems. The list above was taken directly from the package test standard ISO-11607.
Medical Packaging Testing to ISO 11607 and Other Sterile Barrier System Test Standards
As an industry leader in FDA, medical and pharmaceutical package testing, Keystone Compliance can meet all of your package testing needs. Regardless of the barrier system, our team understands the requirements. We streamline the process. Receiving ISO-11607 certification can be challenging. Let us walk you through our proven process.
Other applicable tests include:
Request a quote to experience the Keystone Compliance difference. If you have questions, contact us. Rely on our expertise to guide you to pharmaceutical package testing and medical device package testing.