Medical Device Assembly & Packaging FAQs

Package Design

What package design services does J-Pac offer?

J-Pac offers a turnkey ISO/FDA compliant package design process that can be integrated into your technical files.

  1. We start with documenting customer requirements for packaging, which includes usability issues and aseptic transfer requirements, as well as labeling preferences.
  2. Next, we document the packaging system requirements that consider storage and transportation conditions, cleanliness, bioburden, and expected environmental stresses and constraints. Sterility methods and material compatibility are also assessed at this time.
  3. Based on these inputs, we design both the sterile barrier system that will prevent microbial contamination as well as the protective packaging that will protect both the product and the sterile barrier system during shipment.
  4. Next, we manufacture prototypes under worse-case manufacturing conditions and test the feasibility of these designs in our in-house lab to ensure a high probability they will pass simulated distribution testing.
  5. Once the customer approves the prototypes, we can test usability with our panel of surgical nurses to ensure we meet the requirements for usability.
  6. All of this design work will be conducted under an ISO 13485 quality system including requirements specifications, test protocols, validation plans, and test reports and these are provided to the customer for their technical files. We also manage all outside testing services.

Do orthopedic implants need to be double packaged?

There is no regulatory requirement for double packaging orthopedic implants but there are several factors and requirements of ISO 11607-1 that influence the decision. Section 6.2.2 requires that the package allow the product to be presented in an aseptic manner. While this does not require a double package design, some surgeons prefer to have a “belt and suspenders” approach where the inner package prevents any unnecessary contact while sitting in the sterile field. Additionally, many circulation nurses prefer the ability to transfer the device to the sterile field without waiting for someone in the field to take it out of the package. A double package design can facilitate this - often called “dumping,” “throwing,” or “dropping,” by OR nurses. Additionally, the standard section 6.1.1 requires that the package protect the safety of the user and patient. Some implants have sharp features that may make a double package design desired. Lastly, the issue may come down to surgeon preference.

Packaging & Package Validation

How long does a package design and validation take from start to finish?

Should the packaging performance qualification (distribution simulation) be done at the same time as the stability study?

No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.

Stability testing is testing the sterile barrier system. The stability test will demonstrate the shelf life of the sterile barrier irrespective of what is inside the package.

Performance testing is testing how the packaging system responds to shipping and handling stresses. The performance test must demonstrate that expected shipping stresses do not compromise the sterile barrier.

How do you validate packaging?

Packaging validation is complex. There are several processes that must be completed

  1. The manufacturing process to produce the packaging’s sterile barrier system must be validated. This requires an Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to be conducted on the manufacturing equipment.
  2. Packaging performance testing must be completed. This includes manufacturing and sterilizing under worst-case conditions and subjecting the packaging system to simulated distribution testing.
  3. A stability study must be completed and is typically done with both accelerated and real-time aging studies.
  4. Both the performance testing and stability study require tests for seal integrity and seal strength as well as an evaluation of product protection.

What testing has to be done under worst-case conditions?

ISO 11607-1 Section 6.3.4 states, “Performance testing shall be conducted on the worst-case sterile barrier system produced at the specified process limits of forming and sealing and after exposure to all the specified sterilization processes.”

The Performance Test includes the simulated distribution test and is a separate test from the sterile barrier stability study. In practice, the most typical “worst-case” manufacturing conditions are related to variables affecting seal strength. However, there is no formal definition provided by the standard. It is up to the manufacturer to define “worst-case” manufacturing conductions.

Are microbial challenges required for validation?

There is no universally accepted method of demonstrating microbial barrier properties, although there are efforts to address this that may eventually be incorporated into the standard. The part 1 standard section 5.2.2 indicates only that the microbial barrier requirement can be demonstrated by showing the material is impermeable. Annex C requires that impermeable materials for sterile barrier systems shall be tested for air permeance in accordance with ISO 5636-5. Other tests are noted in Annex B. In practice, demonstrating a sufficient microbial barrier is performed on the material itself by the raw material supplier and their test reports can be referenced in the MDM’s technical file.

Do I need to include an IFU (Instructions For Use) when testing?

The IFU is required for the package performance test because it may impact the integrity or strength of the sterile barrier during shipping and handling. For example, an IFU with sharp edges may cause tears.

How do I determine sample size?

There is no single standard for sample size selection. When determining the right sample size for your product, the most important factor to consider is risk. ISO 11607-1 section 4.3 indicates that sample sizes must be based on some statistical rationale and references sampling plans in ISO 2859-1 and ISO 186.

Is cleaning validation required for orthopedic implants?

If the orthopedic implant is cleaned prior to packaging, the cleaning process must be validated to ensure a high probability that the cleaning specifications are met (FDA CGMP). There have been numerous recalls in orthopedics caused by cleaning processed getting out of control, which left patient harming contaminants on the product. A cleaning validation should be evaluated starting with a product and process FMEA that shows possible sources of contamination and their impact and severity.

What tests are used for a cleaning validation?

Typically, testing covers three areas:

  1. Cytotoxicity: a test for overall safety, measuring if the device material or residuals are cytotoxic.
  2. Bacterial Endotoxin: a test of harmful endotoxin contamination, which is typically introduced by water and can be very dangerous to patients.
  3. Bioburden: a test of fungal or bacterial contamination.

ISO 11607

What is ISO 11607?

ISO 11607 is the standard for packaging terminally sterilized medical devices and is comprised of two parts.

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

ISO 11607-2:2006 specifies requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems and packaging systems.

Part 1 addresses Materials and Design while Part 2 addresses Packaging Process Validation. These are both required to satisfy the Essential Requirements of the European Directives to achieve CE Marking. Additionally, this guidance document is recognized by the FDA and used for premarket review submissions.

Shelf Life Testing

What is the determining factor in determining shelf life?

The FDA defines shelf life as, “the term or period during which a device remains suitable for its intended use.” Fitness for use can be impacted by both maintaining sterility of the package and ensuring the device performs as specified after aging. A risk-based approach should be used to determine the potential impact of using a device that may no longer be fit for use. Some devices will experience degradation over time and the risk of that degradation to the device’s fitness for use must be assessed when determining specifications and tolerances for manufacturing and components.

A stability study must be conducted on the sterile barrier system. Samples (without product) typically undergo both accelerated and real-time testing to establish the shelf life of the seal. Accelerated testing is allowed for market launch but must be followed up by real-time data. Accelerated aging should follow ASTM F1980, which details the Arrhenius equation that is commonly used. This equation is based on the principle that every 10°C increase in temperature doubles the reaction rate. Both accelerated and real-time aging should be done on packages that have undergone worst-case sterilization.

Product testing can take many avenues including material strength testing as well as visual inspection and functional testing. The product stability tests should be conducted on a packaged product that underwent worst-case sterilization and simulated distribution.

Can the product shelf life testing be done at the same time as the stability study for the sterile barrier?

The product shelf life testing and the stability study should be done separately. The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the post-aging performance characteristics of the device. These are two separate items and should be tested separately. The temperatures that are appropriate for SBS materials may not be applicable to device materials. This may jeopardize the otherwise successful stability study on the SBS. When devices are included with the SBS during stability studies, they often interfere with many of the tests that are conducted on the SBS at each aging interval. Devices often have a functional shelf life, which is much less than that of the SBS. These device limitations would unnecessarily shorten the dating claims for future products using the same SBS materials.

MDMs that include devices in their SBS stability studies often end up linking that particular device with the specific SBS used. They then feel it is necessary to repeat the stability study on the same SBS materials if a different device is packaged in it. This is not true. It is much better to keep SBS stability studies independent from any specific device.

How does J-Pac perform a cleaning validation?

J-Pac uses approved protocols for all validations, including cleaning. The validation is designed to show that contaminants that come in contact with the product during manufacturing and packaging are safely removed. These contaminants include organic residues (such as oil), inorganic residues (such as leftover particulates from processing), and microbiological contaminants (such as bioburden from inadequate operator hygiene controls).

The key components of the validation are:

  1. Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
  2. Benchmarking non-cleaned parts
  3. Establishing acceptance criteria
  4. Grouping of samples by material type/family, cleaning process
  5. Identification of worst-case conditions to test
  6. Establishing a statistically rationale sample size
  7. Establishing the cleaning process steps and parameters
  8. Post cleaning testing
  9. Establishing Alert and Action Levels
  10. Establishing post validation sampling plan and change control plan

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