Medical products have developed very well in the last few decades. With advances in the medical sector, medical packaging will also change considerably by 2020. Packaging market for disposable medical devices will reach more than US$4.0 billion by 2016.
With continuing growth of Medical Device Industry, the need for sterilizable packaging, barrier packaging and other packaging requirements for medical/surgical products, is increasing. With increased performance requirements, medical packaging converters and material suppliers are faced with challenges to provide products to satisfy these needs.
Medical packaging requirements are as varied as the products being packaged. Because of the importance to human health, medical packaging must utilize the highest performance materials available in order to provide maximum protection to the product being packaged.
There is more to medical device packaging than simply creating a flashy package that gets consumers’ attention. It is important for medical device manufacturers to realize that the packaging for their devices is as important as the product. If the integrity of the package and sterility of the device is violated, the device would be useless.
Medical device packaging: The largest source of sterility recalls
“Sterility Recalls” is a disturbing issue within the healthcare industry. “The largest source of sterility recalls [80 per cent according to some sources] is packaging failures. Packaging design has to match product complexity. Reasons for the packaging recalls stem from matters such as packaging processes that are not validated, inappropriate sealing, and supplier quality issues.
In the changing landscape of the healthcare industry, one major change is the increase in more complex products including:
- Combination products, such as the pairing of a delivery device and a pharmaceutical
- The growth of kits, and larger products made up of more items connected together whereby reducing the amount of manipulation and handling required by healthcare pros
- More microbiologic-centric products like skin tissues.
More complex products mean packaging/sterilization pros must consider more complex material structures, and understand that materials and products are likely to be more sensitive to sterilization.
Major factors responsible for packaging failure recalls are:
Lack of technical expertise
Incoming group of younger technical talent require thorough on-the-job training and expertise.
- Not validated packaging processes
- Inappropriate sealing
- Supplier quality issues
Batch sizes for testing: Which may cover the issues such as no. of batches of materials to be used, sterilization stresses to be placed on packaging, etc.
- Testing packaging and product with the maximum stress exposure
- It may be useful to test the product in the package, even though testing just the packaging is a simpler, less costly process.
Sterility assurance and packaging professionals need to work together to make sure that the testing performed will provide a safe and effective package.
Sterile packaging shelf life
Commercial introduction of new products carries with it the challenge of assigning to them an effective shelf life, as well as ensuring that the packaging chosen for them is appropriate for the intended sterilization, transportation, storage and end use.
Accelerated ageing protocols
Understanding the impact of time on the efficacy of a sterile medical device often relies on accelerated ageing protocols. Such protocols are generally accepted as valid for testing new product introductions, provided real-time ageing is in place to confirm accelerated ageing test results. Devices are generally regarded as sterile as long as package integrity has not been compromised.
Typically, during ageing studies, a series of tests are carried out to assess package integrity and the physical properties of the packaging materials. Packages that have been sterilised and aged in this manner are then sometimes subjected to shipping studies.
It is helpful to divide these different approaches into two categories: accelerated ageing, where the effects of time on packaging and its contents are being studied, and environmental challenging, where extremes of temperature and/or humidity are simulated to determine the impact of difficult environments on packaging systems.
Making material selections
Different materials have different sensitivity to moisture, so conclusions regarding a given material’s suitability as a packaging component may not be valid if humidity is not controlled. For example, paper is particularly sensitive to humidity. Excessive drying negatively impacts its strength properties, and excessive humidity can lead to mould growth. Some laminates commonly employed in medical packaging may fail under conditions of extreme humidity.
Ultimately, the medical device manufacturer must make the final decision regarding the suitability of a packaging material to ensure the efficacy of a sterilized medical device.
For selecting the right material for packaging, several factors such as temperature, adhesives, moisture resistance, package porosity, thermal capacity, cling resistance, pressure, device size and shape, device composition, etc. must have been considered.
National and international packaging standards, regulatory compliance, accelerated aging, package failure analysis are amongst the issues important for the medical device industry to understand. Packaging has to help reduce hospital-acquired infections, which requires packaging that maintains its integrity, withstands sterilization, and protects against damage to expensive devices. The main objective is that the device package should protect the device during handling and shipping and from the environment and microorganisms until the package is opened.
The key essentials :
- Packaging design requirements
- The packaging design should highlight a clear expectation of the function, limitations, special features, aesthetics, product/company branding, cost limitations, size limitations, sterilization method, labeling requirements, storage requirements, and possible adverse conditions of use and/or distribution and storage.
- Packaging system hazard analysis
- Goal of a packaging system hazard analysis is to eliminate all high-severity hazards and reduce as many medium- and low-severity hazards as possible. Two prime high-severity hazards are breaching the sterile barrier and damage to the medical device that may impact its safe and effective use.
- Evaluation of similar or competing devices
- Try to obtain a similar device or competing products for packaging design review.
- Clinical application of sterile medical device
- One should gather information on the direct use of their sterile medical device on the patient so that the specific role their packaging system plays in the device will be safe and effective use.
- Distribution, storage and handling of medical device
- Today's increasingly complex supply chains require the package designer to perform a thorough investigation of the anticipated distribution, storage, and handling conditions of their medical device. Discussing these issues with supply chain representative, and flowcharting the distribution channel(s) of their medical device can be adopted.
Prototype
Prototyping packages will give the opportunity to evaluate the performance of different sterile barrier system designs. Parallel path development of multiple design options will help ensure project and timeline success if an unanticipated packaging design flaw presents itself.
The sterile barrier system, including simulated or real devices, for these top issues:
The package can be effectively sterilized via the designated method.
The package does not damage the device or present a risk to patient safety (sterility breach).
The package/device can be assembled with a time standard acceptable to your manufacturing team.
Medical device packaging will become easier to use, less costly to produce, and provide much better protection. Some of the advances in medical packaging will include: Over the coming decade, medical packaging will become more interactive which will require use of different materials. In USA, the FDA is encouraging that each primary package produced should carry an RFID tag with a unique code. In the future, it is projected that such tags will activate packaging line operations such as labeling, provide data for pedigree records, and help track and trace product through the supply chain to prevent counterfeiting and diversion. Intelligent shelves and storage cabinets will communicate with the tag permitting automated inventory tracking in hospital and retail settings. RFID tags along with printed electronics, nanotechnology and related nano materials will provide on-package tools to alert customers/ consumers if a product is out of date.
(The author is CEO of Medical Plastics Data Service)