A newly emerging field in packaging development, i.e., medical device packaging. In the last decades, the dynamic evolution of new professional medical device packaging.
Sterile disposable medical products are a relatively new product group, in existence only since the 1960s. The arrival of this new product group created an increased healthcare quality by utilizing single-use sterile medical products.
Why need a sterile barrier for the medical device packaging?
If the packaging is neglected as an essential aspect of a medical device. When sterile medical devices are required, inadequate packaging can cause the following problems:
• Enhanced patient infection risk if product sterility is compromised by faulty seals, pinholes, breakable packaging materials, or packaging delaminating, eliminating, or cracks upon opening.
• Hampering of a surgical method because of challenges in product classification or aseptic transfer, or must replace product chosen for use because the package is either initially defective or damaged during the opening.
• Increased hospital costs due to rejected products or unnecessary storage space requirements
• Increased production costs for refund/replacement of damaged products and recall of products with possibly compromised sterility or integrity.
Medical Device Packaging Design
The development of these one-way products has reduced the risk of contamination from previously used products sterilized after each use in the hospital, where errors were probable in the sterilization process. Based on the “Kleenex” principle, the advent of this product group eliminated the cost and risk of in-hospital sterilization.
List of medical devices provided by FDA
This product group has been growing, with more products being introduced in the healthcare industry each year. These products have a new set of protective requirements that their packages have to meet.
Because the products are disposable after one use, the packaging cost must not significantly increase the product’s price, so along with functional protective requirements, cost constraints frequently restrict the packaging. This is not true of all sterile disposable products because many may cost several hundred dollars, which can afford higher package costs.
Compatibility of Medical device
We need to find the compatibility of packaging material with sterilization processes during the selection of packaging. Also, it must take care to ensure the materials are compatible with the sterilization process. The total product development effort must involve the packaging design process and incorporate the package design, manufacturing process, sterilization process, and environmental effects.
Selection of Packaging Material
When selecting the materials for sterile barrier systems, it is essential to understand the sterilization process they will be subjected to and its limitations. The sterile barrier system must allow effective sterilization of the medical device, withstand the sterilization process, and maintain the microbial barrier after sterilization. Any detrimental effects of the process on the materials mustn’t affect the sterile barrier’s overall functionality during subsequent storage and device usage.
In selecting materials for sterile barrier systems for medical devices, many aspects need to be considered, including the following:
- Aseptic barrier during packing
- Compatibility with the device
- Maintain sterility up to the point of use
- Biocompatibility/toxicological of packaging material
- Barrier properties – Moisture, Gases, Light, etc.
- Physical/chemical properties of Packaging material, e.g., porosity
- Method of packing, e.g., sealed, folded, taped, need for aseptic opening.
- Material limitations, e.g., max. sterilization temperature for spun-bond non-woven materials of polyethylene is 127°C
- Compatibility with printing and labeling systems
- Storage condition
- Transport worthiness test
- Recycling Aspects, e.g., disposal/recycling requirements, consumption of raw material, water, and energy during the production process, emissions to water, soil, and air, etc.
The list of Medical Device Packaging standards are:
- ISO 11607-1 Packaging for terminally sterilized medical devices, requirements for materials, sterile barrier systems, and packaging systems
- ISO 11607-2 Packaging for terminally sterilized medical devices, validation requirements for forming, sealing, and assembly processes
- ISO/TS 16775 – Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
- EN-868 Parts 2-10 Packaging for terminally sterilized medical devices (wraps, pouches, and reels…), particular requirements
- ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
When determining the packaging materials and design, the key factors to consider are:
- The medical device’s specific nature and the intended sterilization methods (e.g., ethylene oxide (EO), gamma irradiation, electron beam, steam, low-temp. oxidative).
- Its intended use.
- Expiry date.
- Transport and storage.
Fitness test for the medical device packaging
Fitness for purpose or Testing methods for final medical device packages required by the standards. It needs five essential ideas of device packaging: to contain, inform, protect, display, and transport.
It requires the tests used to validate the primary package’s sterile integrity and strength
- Visual inspection
- Burst test (paper and paper products)
- Peel/tensile test
- Bubble leak or leakage test
- Microbiological challenge testing
- Trace Gas (Sniffer) testing
The Visual Inspection ASTM F1886 test, for example, covers the determination of channels in a package seal down to approx. 75μm (0.003in.) with a 60–100% probability. This qualitative measure (accept/reject) helps to evaluate unopened seals’ appearance to determine the presence of defects.
Key points to think about are: have you considered your sealing process during OQ and PQ? And have you set accept/reject levels for your sealing process?
In the package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria. He said many medical device manufacturers struggle with deciding what they need to do to comply with ISO 11607 and which procedure to utilize for performance testing – ASTM or ISTA. ASTM or ISTA standards are widely used and listed in ISO 11607, a recognized consensus standard by the FDA; therefore, either ASTM or ISTA test procedures can be employed.
This event highlighted that the time required to gather all this packaging data means that we must consider packaging requirements parallel with the device development if costly delays to market are avoided.