Medical device packaging
Sealing
Barrier
Shelf-life
Medical device packaging has its own separate set of safety and security concerns, for good reason. Packaging not only protects a product from harm or tampering during transit but can display critical product information and brand marketing.
Medical device packaging is crucial to deliver the device to market safely and securely, with the sterile barrier intact. Poor packaging can cause safety issues to the medical device and their consumers.
If a package holds a sterile medical device, it must arrive in hospitals and other medical facilities without any holes or broken seals, and it also has to survive or stand on a shelf for years without breaking.
Medical device packaging is regulated globally. The overall requirement is that the performances of the packaging must answer to what it has been designed for.
Sterile barrier systems (SBS) are intended to ensure the sterility of their contents until opened for use.
They are also designed to permit aseptic presentation of their contents. The sterile barrier system provides protection for the sterile medical device but its ability to do so depends on how it is handled and stored.
When the packaged and sterilized device undergoes repeated handling, additional protective packaging may need to be combined with the sterile barrier system to create an overall packaging system.
Applicable standards
EN ISO 11607-Packaging for terminally sterilized medical devices-specifies the requirements for sterile barrier systems:
- ISO 11607-1-Requirements for materials, sterile barrier systems and packaging- includes the validation of the packaging system design;
- ISO 11607-2- Validation requirements for forming, sealing and assembly processes- cover packaging process validation.
The scopes of these standards apply wherever medical devices are packaged and sterilized. Therefore, they can be applicable to medical device manufacturer, a health care facility, or an organization that reprocesses medical devices.
EN 868- Packaging materials and systems for medical devices which are to be sterilized
Medical packaging must meet 5 key requirements
| Requirements | Features of a sterilization package | Testing |
|---|---|---|
| Biocompatibility and toxicological characteristics | Minimize risk for patient and user | Sensitization, irritation and cytotoxicity |
| Control of conductivity and cleanliness as well as chemical properties and absence of pyrogens | ||
| Guaranteed composition of the material | ||
| Compatibility with relevant sterilization processes | Enable effective sterilization | Sterilizer penetration test, porosity control |
| Bioburden control | ||
| Post-sterilization physical and chemical performance tests, monitoring of material composition. | ||
| Physical resistance and barrier | Provide physical protection and a bacterial barrier proprieties | Testing of physical performances and barrier performance to airborne fluids and particles |
| Follow-up of his physical integrity | ||
| Bacterial tests (BFE/ Germproofness) | ||
| Demonstration of product safety shelf-life and sterility maintenance efficacy | Maintain sterility up to the specified date and point of use | Microbial aerosol challenge test |
| Event related shelf life test | ||
| Post-ageing tests of materials (accelerated and natural) | ||
| Compatibility with forming, sealing and assembly processes of the package | Allow aseptic opening | For films, drapability/ folding and adhesive life tests surface tension control |
| For pre-formed SBS, weldability, adhesive strength and permeability |
Biocompatibility & toxicological characteristics
Biocompatibility is evaluated based on a risk assessment process according to standard EN ISO 10993-1.
For a medical device in contact with the surface of a lesion-free skin for a limited period of time (less than 24 hours), these tests should be considered:
- EN ISO 10993-5:2009 - Biological evaluation of medical devices: Tests for in vitro cytotoxicity
- ISO 10993-10 - Biological evaluation of medical devices: Tests for irritation and skin sensitization
The chemicals released from device materials that contact the body may produce skin, mucosal, or eye irritation. In general terms, such irritation is a local tissue response characterized by the usual signs of inflammation—redness and swelling—and sometimes accompanied by heat and pain. Many chemicals can cause irritation, either immediate or delayed, and some of these may be present in materials as additives, processing or manufacturing aids, or inadvertent contaminants.
For example, the organotin stabilizers used in nonmedical vinyl formulations are corrosive chemicals capable of causing irritation and necrosis when applied to mucosal surfaces; residual concentrations of ethylene oxide present in gas-sterilized devices can produce an irritant response if they are not reduced to acceptable levels before the device is used; and residues of such contaminants as chemical detergents in a particular batch of materials or devices can cause unexpected irritation responses in users or patients.
Toxicological & Patient/Healthcare Professional Safety can be verified by evaluating following properties:
- Conductivity test (BS 6524) / flammability test (CFR16 Part 1610)
- Measurement of pH (ISO 6588-2), sulphate (ISO 9198) & chloride (ISO 9197) content
- Material composition:
- Absence of recycled material to guarantee traceability
- Absence of optical brighteners (EN 868-2 Annex B)
- Free of phthalates, bisphenol A, natural latex, PVC, etc.
- Complies with the REACH directive, the Heavy Metals regulation according to RoHS, etc.
Compatibility tests
- Sterilizer penetration test
- Porosity control (ISO 5636-3)
- Bioburden control (ISO 11737)
- Post-sterilisation physical & chemical performance tests (EN 868 series)
- Material composition monitoring (FTIR spectroscopy)
- Residue test EtO (ethylene oxide)
Physical resistance tests
- Tearing resistance (EN 21974)
- Bursting strength in dry (ISO 2758) or wet (ISO 3689) state
- Tensile strength in dry (ISO 1924-2) or wet (ISO 3781) state
Testing barrier performance to fluids, airborne particles or micro-organisms
- Water resistance (EN 868-2 Annex D)
- Hydrostatic load test (EN 20811)
- Mason Jar Test (EDANA 170-1-02)
- Resistance to low surface tension liquids (IST 80-8)
- Determination of the maximum pore diameter (EN 868-2 Annex E)
- Thickness regularity (ISO 534)
- BFE (Bacterial filtration efficiency) test (ASTM F2101)
- "Germproofness” tests:
- with air passage (DIN 58953-6 § 4)
- in wet condition (DIN 58953-6 § 3)
Demonstration of product shelf-life & sterility maintenance efficacy
Real-time or accelerated ageing test (ASTM F1980)
To demonstrate the shelf-life of the sterile packaging system all of the above mentioned property tests should be repeated after 5 years real-life or accelerated ageing.
Microbial aerosol challenge test
This test validates the finished packaging. The objective is to determine the effectiveness of the bacterial barrier of sterilised packs subjected to contamination illustrating maximised hospital storage conditions (Worst case scenario).
Event related shelf-life test
The objective is to determine the effectiveness of the bacterial barrier of sterilised packs subjected to typical events of maximised hospital storage conditions during real-time storage (Worst case scenario).
Compatibility with packaging forming, sealing & assembly processes
Tests for sterilization films
- Drapability / folding tests (ISO 9073-9 / ISO 2493)
- Adhesive strength tests (surface tension control)
Tests for pre-formed sterile barrier systems
- Ability to be welded or bonded (EN 868-5 Annex D / EN 868-4 Annex C )
- Peel test EN 868-5 / ASTM-F88
Contact
Mark Croes
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