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?

Package Design (Phase 1): 13 Weeks

  • Package System Requirements
  • Sterile Barrier Design
  • Protective Package Design
  • Prototyping
  • Verification Testing
  • Sterile Presentation Test

Sealing and Manufacturing Process Development (Phase 2 - 3): 16 Weeks

  • Thermoforming & Sealing Tooling
  • Thermoforming IQ/OQ
  • Sealing IQ/OQ
  • Device Assembly IQ/OQ
  • Label Development
  • Build OQ-Low for Transit Test

Transit Testing and Seal Testing (Phase 4 - 6): 13 Weeks

  • Expose to Worst-Case Sterilization
  • Transit Simulation
  • Accelerated Aging Testing
  • Real-Time Aging Testing
    • Seal Integrity Test
    • Seal Strength Test
    • Product Stability Test
  • Seal Testing
    • Accelerated Aging
    • Real-Time Aging
    • Seal Integrity Test
    • Seal Strength Test

Sterilization Validation: 8 Weeks

  • Manufacturing PQ
  • Single Lot Verification 1
  • Single Lot Verification 2/3 (Additional 16 Weeks)

These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.

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.

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