Quick Answer (for busy buyers)
Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.
- For SEA’s humid climate, component selection is critical.
- We specify pumps with internal mechanisms made from polypropylene (PP) or acetal, which resist moisture absorption and swelling.
- Spring materials are stainless steel to prevent rust, which is a common failure point that leads to clogging or inconsistent dispensing.
- The sealing gasket material is also chosen for its resistance to mold and degradation in constant 80%+ RH environments.
- During sampling, we run salt spray tests on metal components and function-tests units after exposure to high humidity chambers.
- For production, we implement inline checks on every batch, including a torque test to ensure the actuator hasn’t become stiff or stuck due to material expansion.
- We can support documentation like MSDS for all components and a Declaration of Conformity for the assembled packaging.
- Lead time for tooling new components is 45-60 days, with a standard MOQ of 10,000 units per component.
- Final packaging includes silica gel in master cartons to control moisture during ocean freight.
Buyer outcome
A launch-ready compliance plan: inputs collected, roles assigned, and update cadence defined.
Most common blocker
Missing facility information + inconsistent ingredient/label snapshots across SKUs.
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This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.