Sterile Barrier System

A Sterile Barrier System (known as SBS) is often present (and mandated by regulation) in the medical packaging industry. It refers to minimum packaging that prevents contamination and helps to sterilize the finished product. The system must guarantee sterility throughout the whole supply chain from production through to the operation room. ISO 11607-1 specifies the requirements related to the compliance of the packaging for sterilised medical devices, including materials, sterile barrier systems and packaging systems.

A Sterile Barrier System is defined as the components of a Medical devices’ Packaging that minimizes the risk of access of microorganisms. A Sterile Barrier System prevents contamination and keeps the final user safe.

When we talk about an Sterile Barrier System, it is important to understand the difference between primary packaging and a more complete SBS:

A sterile barrier system is defined as all the sum of the components that are involved in the sterilization process. Depending on product design and specifications, a sterile barrier system may also include a product’s primary or secondary packaging. An SBS might be a surgical kit that includes multiple devices in a tray, with the tray inside a pouch. The full kit would be sterilized as it is, making it an SBS.

There are numerous forms of barrier systems. Although each has its unique qualities, most of them have similarities:

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 preformed 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 non-woven 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 bag. 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.

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.

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 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.

A sterile barrier system is defined as a part of ISO 11607. ISO 11607 specifies the requirements and test methods for the materials used in and the sterile barrier systems themselves, as well as preformed sterile barrier systems and packaging systems that are intended to maintain sterility until the point of use, which is usually a medical facility, operating room, or lab.This standard is harmonized with the medical device directives in Europe. It consists of 2 parts:

• ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes.

As a harmonized standard, ISO 11607 provides presumption of conformity with the essential requirements of the MDD 93/42/EEC as they apply to sterile packaging. Part one of the standard deals with materials and design as well as design validation, while part two covers packaging process validation. Process validation applies to assembly and sealing processes, the final seal as well as the seals of the preformed sterile barrier systems.

The main concerns regarding ISO 11607 requirements are eliminating and reducing risks. They refer to, for example, risks associated with the chemical, physical and biological properties of materials including toxicity, bio-compatibility and compatibility with sterilisation systems. They also refer to the risk of infection and microbial contamination and specify the use of non- reusable packaging and/or appropriate procedures to minimise the risks for devices which are to be delivered in a sterile state.

Medistri possesses an in-depth comprehension of the Sterile Barrier System to meet your regulatory requirements and to guarantee sterility throughout the whole supply chain from production through to the operation room.