Three layers of packaging, three different owners
Medical device packaging has three layers, and each one has a different owner. The sterile barrier system, if the device is sterile, is validated by the manufacturer, typically under ISO 11607. The protective packaging, such as the unit carton and case pack, is also part of the manufacturer's design and labeling. The shipper, meaning the outer box, void fill and pallet configuration added at fulfillment, is where your 3PL comes in.
A fulfillment provider should never open, alter or repackage the first two layers unless that activity is explicitly defined, validated and appropriate to its registration status. Its job is to protect them.
Why sterile devices need extra care
A sterile barrier that is punctured, crushed, wet or compromised at a seal is no longer a sterile barrier. Hospital receiving and clinical staff are trained to reject devices with damaged packaging, and many will reject an entire case if the outer carton looks wet or crushed.
For sterile and single-use devices, ask your 3PL how it handles cases with visible damage at receiving, whether it ever breaks case packs for each picks, and how it prevents tape guns, box cutters and strapping from contacting inner packaging. Case breaks should only happen where your packaging design and labeling support selling inner units.
Choosing the right shipper
The shipper should be chosen per order profile, not by whatever box is closest. Practical rules:
- Size the outer box so the product cannot shift, with at least modest clearance on all sides for cushioning
- Use void fill that does not shed particles or moisture onto inner packaging
- Keep labels on unit cartons visible and unobstructed when the receiver opens the box
- Never put shipping labels over device labels, UDI barcodes or lot and expiry information
- Separate fragile powered devices from heavy accessories in multi-item orders
Many brands validate standard shipper configurations against a distribution test standard such as ISTA 3A for parcel or ASTM D4169, then lock those configurations into the 3PL's packing instructions.
Parcel versus LTL for healthcare customers
DTC and small clinic orders usually move by parcel. Hospitals, health systems and distributors often require LTL or consolidated freight with specific rules: dock appointments, maximum pallet heights, labeled pallets with GS1-128 serial shipping container codes, and an advance ship notice sent before the truck arrives.
Pallet builds matter. Columns stacked straight, corner boards where needed, stretch wrap that does not crush top tiers and a clearly labeled top-of-pallet all reduce receiving rejections. If a customer's routing guide has penalties for non-compliance, your 3PL should have that guide on file and pack to it.
Temperature-sensitive shipments
Devices, reagents and diagnostic components labeled for refrigerated or controlled room temperature need packaging qualified for the transit lane and season. That usually means insulated shippers with refrigerants, packed to a documented pack-out, and shipped on service levels short enough that the qualified duration is not exceeded.
Ask how the provider adjusts pack-outs between summer and winter, whether it uses data loggers on any lanes, and how it handles shipments that will sit over a weekend. Holding temperature-sensitive orders on Thursday or Friday afternoons is a common, sensible rule.
Labels, paperwork and what travels with the box
Medical device shipments often need more than a shipping label. Depending on the customer, the order may require a packing list matched to the purchase order, lot and expiry information printed per line, a certificate of conformance supplied by you, or instructions for use when they are not inside the unit carton.
Define document requirements per customer in the 3PL's system so they print automatically. Manual inserts work until volume grows, then they get missed.
Handling damage claims and complaints
Damage in transit is a carrier claim and, potentially, a product quality event. If a customer reports a damaged device, the report may also be a complaint that your quality system must evaluate.
Your 3PL should capture photos, preserve the shipper when practical, record the lot and serial affected and route the report to your complaint process within the timeframe set by your quality agreement. Treating every damage report as only a shipping problem is how complaint records end up incomplete.
Questions to ask your 3PL about packing
Before go-live, walk the packing line with your provider and ask specific questions rather than general ones:
- Which shipper sizes are approved for each SKU or order profile, and who can change them?
- Are packing instructions displayed at the pack station by SKU, or held in a binder?
- What happens when the approved box size is out of stock?
- How are case packs opened, if they are opened at all, and with what tools?
- How are damaged or crushed inbound cases identified and held?
- Who checks that UDI, lot and expiry labels remain visible after packing?
Good answers point to system-driven instructions and documented exceptions. Answers that rely on experienced packers remembering the rules work only until volume rises or staff changes. Change control matters here too: a switch in carton supplier or void fill type is a packaging change worth reviewing against your validated configurations.
Frequently asked questions
Can a 3PL repackage medical devices into smaller units?
Only if that activity is defined and appropriate. Repackaging or relabeling devices can trigger FDA establishment registration requirements and must follow your validated packaging and labeling. Most device fulfillment is ship-as-received in the original unit and case packaging.
What is ISTA 3A?
ISTA 3A is a distribution test procedure from the International Safe Transit Association that simulates parcel delivery hazards such as drops, vibration and compression. Brands use it to check that a packed shipper protects the product through typical small-parcel networks.
Should shipping labels ever cover a UDI barcode?
No. Shipping labels, tape and stickers should never cover device labels, UDI barcodes or lot and expiry information on unit or case packaging, because receivers need to scan and read them.