Turnkey validation for sterile label claims

Regulators define validation as documented evidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. It's the foundation for any sterile label claim in healthcare.

The protocol outlines objectives, process and equipment details, device description, testing numbers with rationale, loading configuration, bioburden estimation, resistance studies, sub-lethal cycles, three cycles below nominal conditions, two full cycles at nominal and upper tolerances, acceptance criteria, and ongoing maintenance requirements.

Yes. We generate the protocol, run all cycles, coordinate third-party testing, and deliver a comprehensive report. Everything is included in the quoted price—you provide the devices and your signature.

A single-lot release is a streamlined study for devices in early development stages heading into clinical trials. It allows your lot to carry a sterile label without full validation, typically conducted under an Investigational Device Exemption (IDE).

Device quantities vary by test type. Bioburden testing requires three units, sterility testing eight to twenty units, EO residual one to two units, and LAL three units if applicable.

Usually no. We evaluate your new device against the existing validated process by comparing design, materials, sterile barrier, and load configuration. If the change is minor, a paper review may suffice.

Yes. Most teams have already validated their sealer at manufacturing or a contract facility. We establish expiration dates by testing your product in its actual packaging system under real-world conditions—sterilization, shipping, and handling included.

A study that exposes your packaged product to anticipated shipping hazards—vibration, impact, drops, and environmental stress. After exposure, we examine sterile barrier integrity and strength. ASTM D4169 is the standard we follow.