K. Zacharias Oliver Medical, Grand Rapids, Michigan, USA
Start at the beginning
Packaging engineers and purchasers of packaging materials are well aware of the mounting pressure to reduce costs. When developing a sterile barrier system for a device, the right balance between cost and protection should be incorporated into the package at the start of the project. Taking this approach will ensure the medical device is adequately protected and not over packaged. A less desirable approach is to use excessive amounts of materials in an effort to mitigate all risks. Designing in more materials than are necessary results in a medical device package that costs too much, adds to the waste stream and frustrates the end user because additional storage space and disposal costs are required.
If medical device manufacturers are not taking adequate measures to reduce costs, they will not be competitive in the future. This article provides ideas for reducing the cost of existing packaging and considerations on validation and qualification when changes are made. The process begins with a complete analysis of the sterile barrier system. However, this analysis should not be limited to the unit packaging, but should also include a thorough review of the secondary and tertiary packaging and the manufacturing process. Areas that should be explored and ideas for potential cost reductions are discussed below.
In general, the sterile barrier system comes in the form of premade pouches, thermal form-fill-seal (TFFS) packages, trays with lids and bags with breathable vents. In each case, there is potential to lower cost by down gauging, changing materials or changing the configuration altogether.
Down gauging. Here, it is necessary to look into the history of the sterile barrier system and the original validation that qualified it. Was the lower end of material thickness explored? In many cases, because of timing constraints and other internal pressures, the least risky option is chosen to ensure the greatest chance of success during the first validation attempt. A package developed in this way is an ideal candidate for cost reduction through film down gauging.
Alternative materials. In many cases, the film has already been down gauged to the limit. In this situation, it may be viable to look at alternative materials. For TFFS packages, nylon or metallocene based films can be used instead of the traditional ionomer based forming webs For rigid tray applications, conversion from glycol modified polyethylene terephthalate to high impact polystyrene could be employed if it is acceptable for the product to be in an opaque versus clear package. These are just two examples of ways to reduce cost by using alternative films. Device manufacturers need to work with their packaging suppliers to identify the best materials for making cost improvements. Alternative materials for use with TFFS top web, tray lids and pouches should be reviewed. If a breathable top web or lid is being used and the product is sterilised via irradiation, conversion to a nonbreathable film can give cost savings.
Furthermore, there are many grades of medical papers that are available such as papers that are reinforced with synthetic polymers and/or synthetic latex. These papers, although not attaining the equivalent strength characteristics of Tyvek (DuPont Medical Packaging), are more than appropriate for many applications. Papers provide a porous structure that is suitable for gas sterilisation and they have microbial barrier capabilities.
If a secondary package such as a dispenser carton is being used, question whether it is necessary. Is the product robust enough to be placed directly in the master corrugated shipping carton? Medical device manufacturers perceive secondary packaging as a benefit to the customer because it may allow for ease of handling and distribution within a hospital. This may be the case; however, the customer may see this extra packaging as difficult to dispose of and thus an inconvenience. As an alternative, it may be possible to use a thin gauge polythene bag as secondary packaging, which will result in far less cost and waste compared with a carton.
Medical device manufacturers often overlook tertiary packaging. This is understandable considering the emphasis placed on the sterile barrier system. However, significant savings can be derived from using less corrugated packaging. Consolidating corrugated carton sizes can result in better pricing by the supplier, achieved through volume discounts. This will result in increased efficiencies with respect to ordering patterns and inventory control. Optimising the size of existing cartons and/or increasing the number of units per carton can deliver savings in sterilisation and transportation costs.
Some of the greatest cost savings can be gained by changing processes or implementing new ones. However, these savings entail capital costs and implementation time. In looking at options for reducing costs, an assessment of pouch versus TFFS versus tray packaging systems needs to be made.
Typically, premade pouches and trays are used for lower volume products and TFFS for larger volume products. The financial analysis to determine which to employ is straightforward. Products that have grown in sales over time make good candidates for conversion from pouch to TFFS. The annual savings provided by converting to a TFFS package is easy to calculate and can be used to justify the capital expenditure to purchase a TFFS machine.
Table I. (click to enlarge) Factors to consider when making a cost comparison of packaging systems.
An important area to focus on is processing speed. Ensuring TFFS, pouch band sealer and tray sealer machines are fully utilised is essential, because maximising the number of packages produced per minute has a significant impact on cost.
Specific to TFFS processes, an important consideration is maximising the tooling array so that the entire index of the machine is utilised. Additional cost savings techniques that need to be evaluated for any TFFS process include automated placement of the device into the package and automated off-loading of packages into the shipping carton.
Inline printing is also a valuable area for review. Ordering unprinted top web from the packaging supplier together with the associated volume discounts will yield significant price reductions. Additional savings can be derived because there are fewer part numbers to manage with regard to specification maintenance, inspection and billing. The efficiency with which artwork can be changed is also increased. When art is changed, there is no existing inventory to scrap at a loss. Common types of printing are
- flexographic: this is suitable for nonvariable information and has a low cost per package
- thermal transfer: this is used for variable information and has a high cost per package
- ink jet: this is suitable for variable information and is low cost per package.
Another technique to achieve process efficiency is to minimise downtime with the use of automatic splicing and roll changes and optimise tooling change over.
To determine what is required to validate a new or changed packaging system, an understanding of ISO 116071 must be achieved. Though it may be intimidating, the prospects of validation or revalidation should not deter medical device manufacturers from making changes that improve material cost or process efficiencies. Issues that need to be reviewed as part of any medical device packaging material or process change include:
- Validation/revalidation: ISO 11607 provides guidance in this area, specifically on installation qualification, operational qualification and performance qualification. Testing must also be performed to verify that the sterile integrity of the package has been maintained from manufacture to point of use.
- Stability: ageing studies must be conducted to support expiry date claims.
- Biocompatibility and toxicological attributes are required using ISO 10993, Biological Evaluation of Medical Devices.2
- Sterilisation: Materials must be compatible with the sterilisation process and changes evaluated to ensure no negative impact to sterilisation efficacy.
- Microbial barrier: New porous structures must be evaluated to ensure they provide an effective microbial barrier.
Pressure to reduce waste, process inefficiencies and ultimately cost are real issues for medical device manufacturers. Ideas for cost savings can come from many sources including the operators that handle the process everyday, manufacturing engineers, packaging engineers, purchasing representatives and suppliers. Often the best format for generating cost saving projects is in a brainstorming session that includes representatives from these areas.
A good supplier will seek to partner with the medical device manufacturer and offer cost saving ideas. In addition, packaging suppliers should be able to provide data to make it easier for their customers to qualify new materials and processes. Utilising supplier data in the areas of stability, biocompatibility, waste regulations and bacterial barrier testing should be considered. Ultimately, the packaging supplier should be able to help identify the best packaging materials and processes for the medical device.
1. ISO 11607, Packaging For Terminally Sterilised Medical Devices, Parts 1 and 2, International Organisation for Standardisation, Geneva, Switzerland (2006).
2. ISO 10993, Biological Evaluation of Medical Devices, International Organisation for Standardisation, Geneva, Switzerland (2005).
Kevin Zacharias is an Engineering Programme Manager at Oliver Medical, 445 Sixth St., NW, Grand Rapids, Michigan 49504, USA, tel. +1 616 456 7711, e-mail: firstname.lastname@example.org, www.olivermedical.com.