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Medical

Device

Medical Device

Not every medical device component requires sterile processing. Many parts, from downstream hardware to delivery system components, simply need to be precision cleaned, packaged, and kitted in a certified controlled environment. For manufacturers, routing these parts through a full aseptic facility means paying for capabilities the parts don’t require.

Astro Pak fills that gap. Our ISO 14644-1 Class 5, 6, and 7 cleanrooms in Florida and California provide precision cleaning, cleanroom packaging, and kitting for non-patient-contact medical device components, supported by documented quality systems and process control at every step.

Our proprietary high purity cleaning and passivation chemistry addresses cleanliness considerations for medical device components, including remediation of bio-burden, rouge, and other contaminants to support FDA requirements, while delivering an optimal passive layer for corrosion resistance and maintaining the integrity of laser mark etchings.

We work to your specifications and at your pace, supporting high-volume production runs and compressed delivery schedules as your products scale. Upon completion, we provide cGMP documentation with every job we perform.

CLEANING, PACKAGING & KITTING

Our cleanroom teams process medical device components through validated batch workflows designed to remove manufacturing debris and deliver parts that are clean, dry, and ready for use:

Ultrasonic Cleaning in Deionized Water
Deionized Water Rinse
High Purity Nitrogen Drying
Cleanroom Packaging
Kitting & Labeling to Demand
Cleanliness Verification & Documentation

SUPPLY CHAIN INTEGRATION

Astro Pak does more than clean parts. Your raw material suppliers ship directly to our facility, where we receive, inventory, process, package, and kit components to your demand, then ship finished goods straight to you.

The result: no warehousing raw material, no shipping parts out for processing and receiving them back, and no managing the logistics in between. Manufacturers reduce warehouse footprint, simplify vendor management, and gain a processing partner that scales with production.

Whether you're an OEM scaling a new product launch, a contract manufacturer managing complex component flows, or a device company seeking a cost-effective alternative to aseptic processing for non-sterile parts, Astro Pak delivers certified cleanliness, process control, and supply chain support from coast to coast.