SpecialTeam Cleanroom Assembly and Packaging

Through our partnership with SpecialTeam, CE3S connects you with ISO 13485:2016 certified, FDA registered contract manufacturing for medical devices: cleaning, assembly, packaging, sterilization, validation, and testing under one roof.

Featured Partner

Who Is SpecialTeam?

SpecialTeam is a contract manufacturer of medical devices, formed in 1996 by a proven management team from the medical manufacturing industry. From its facility in Chino, CA, SpecialTeam provides complete turnkey services that take products from components to market-ready, finished goods.

Every project runs through a controlled and verified process built to your specification, backed by a Quality System based on ISO 13485:2016 and ISO 9001:2015.

SpecialTeam was designed to serve start-up and mid-size companies, and every client has equal access to its resources, services, and staff.

Built for Regulated Production

  • Complete product traceability on every order
  • FDA, CGMP/QSR, and ISO adherence at every step
  • Cleanrooms compliant with ISO 14644-2 and 14644-3
  • Centrally located with quick turnaround
  • Equal access to resources for clients of every size

Turnkey Services

From Components to Market-Ready Product

SpecialTeam offers quick turnaround on the full range of services needed to introduce a medical device to market, including procurement from established supplier networks all the way through drop shipping your finished product.

01

Process Development

Creative designs and processes for cost-effective production, including packaging and assembly systems for even the most complicated medical devices and kits.

02

Cleanroom Assembly

Medical device assembly, small parts assembly and sub-assembly, sterile kitting, UV cure adhesives, and ultrasonic welding with process control to ensure quality.

03

Cleanroom Packaging

Impulse heat sealing, rotary band sealing, and thermoform tray sealing for Tyvek pouches, PETG and PVC trays, with Tyvek, paper, foil, and film lidding.

04

Sterilization Coordination

Contract sterilization coordination for your device, with dose range guidance and scheduling handled as part of one verified process.

05

Validation Services

Process and packaging validation performed to your specification and documented to meet your quality standards and regulatory requirements.

06

Testing Services

Seal testing to ASTM standards including seal peel, visual, and dye testing, plus leak flow testing and ultrasonic cleaning of complex components.

5Certified ISO Class 5, 6, and 7 cleanroom suites
1996Serving medical device makers for nearly 30 years
100%Product traceability with FDA, CGMP/QSR, and ISO adherence
USAAll services performed domestically under strict US standards

Capabilities

Assembly and Packaging Capabilities

Custom packaging solutions accommodate a wide variety of requirements for sterile and non-sterile medical devices. To maximize reduction in cost and time, SpecialTeam also coordinates the purchasing, assembly, and packaging of components from various vendors. Capabilities include, but are not limited to:

Sourcing & Materials

  • Plan and procure material to your forecast
  • Select and approve suppliers
  • Inventory of raw material and sub-assemblies
  • Inventory reports on demand

Assembly & Kitting

  • Medical device assembly and sub-assembly
  • Sterile kitting, custom kitting, and multi-packing
  • Fluid fill technology (5ml to 500ml)
  • Ultrasonic welding and ultrasonic cleaning

Packaging & Labeling

  • Pouch sealing, tray sealing, and bulk packaging
  • Modified atmospheric packaging services
  • Lot number, barcode, and expiration date printing
  • Thermal transfer, product, box, and barcode labeling
  • Directions for use

Quality & Fulfillment

  • Seal testing to ASTM standards
  • Sterilization coordination
  • Finished goods management, ship to order

Have a Device or Kit That Needs a Production Partner?

Tell us about your project and a CE3S team member will personally coordinate your opportunity with SpecialTeam. One form, one point of contact, no runaround.

Submit Your Project

The CE3S Advantage

Why Work Through CE3S?

Cumberland Electronics Strategic Supply Solutions (CE3S) has been a trusted supply partner since 1962. When you submit your project below, our team handles the introduction, coordinates your information with SpecialTeam, and stays with you every step of the way.

You get a direct line of contact, consistent communication, and service far beyond the sale, the same partnership our customers count on across all of our solutions.

Tell Us About Your Project

Complete the short form below with your device and production details. It takes just a few minutes.

We Coordinate With SpecialTeam

Our team submits your opportunity directly and follows up on your behalf, so nothing falls through the cracks.

You Get Answers

A quote and next steps come back to you, with CE3S keeping the process moving every step of the way.

Tell Us About Your Project

Provide a few details about your device or kit and a CE3S team member will be in touch. We appreciate your time and look forward to connecting with you.

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