Sterile and single-use device fulfillment protects the sterile barrier and the expiration date above everything else. We handle syringes, catheters, surgical disposables, procedure kits and wound care with strict FEFO and lot-level traceability.
Protecting the sterile barrier
A sterile device is only sterile while its packaging system is intact. Crushed cartons, punctured pouches, moisture and compressed seals can compromise the sterile barrier, and a compromised unit cannot be used. Manufacturers validate their packaging to standards such as ISO 11607, but that validation assumes the product is handled and stored within reasonable limits.
We store sterile product off the floor in clean, dry locations, respect stacking limits printed on shippers, and pick by full inner pack where possible to avoid unnecessary handling. Units with any visible packaging damage are moved to quarantine rather than shipped, and we never open sterile packaging, remove inner packs from sealed sterile units or apply labels that obscure required information.
Expiry and shelf-life discipline
Sterile disposables carry expiration dates tied to sterilization and packaging stability, and hospital buyers watch them closely. Many health system contracts and distributor agreements specify a minimum remaining shelf life at delivery, and short-dated product is refused at the dock.
Our allocation is strictly first-expired, first-out, with minimum remaining shelf-life rules configured by customer or channel. Lots approaching your thresholds are reported in advance so you can sell them into channels that accept shorter dating, use them for samples or training where appropriate, or plan disposition. That discipline protects both patient safety and margin.
Procedure kits and convenience kits
Procedure and convenience kits combine several devices into one package for a specific clinical task. Assembling devices into a kit is often a manufacturing activity in FDA's view, which can bring establishment registration, labeling and quality system obligations to whoever performs it, and kits containing sterile components may require sterilization of the finished kit.
We handle fulfillment of finished kits with lot traceability to the kit and, where your records require it, to the components. For programs that involve kit assembly or relabeling, we can discuss FDA-registered facilities in select markets, and your regulatory team should confirm the requirements for your specific kit before any assembly takes place.
Frequently asked questions
How do you store sterile medical devices?
Sterile devices are stored off the floor in clean, dry locations within printed stacking limits. Sterile packaging is never opened, and any unit with visible packaging damage is quarantined.
Can you enforce minimum shelf life for hospital contracts?
Yes. We configure minimum remaining shelf-life rules per customer, so lots below a customer's threshold are never allocated to that customer's orders.
Can you assemble medical procedure kits?
Kit assembly is often treated as manufacturing by FDA. We can discuss FDA-registered facilities in select markets for kit programs, and your regulatory team should confirm requirements before assembly begins.