Medical DeviceQualified Supplier Directory

 
CleanCut Technologies, LLC

CleanCut Technologies, LLC Company Profile

 

 

http://www.cleancuttek.com
E: karen.koenes@cleancuttek.com
T: 714/864-3500
F: 714/864-3595

Address
1145 N. Ocean Cir., Anaheim, California, 92806, United States
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Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers

Markets Supplied: North America, Europe

 

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CleanCut Technologies is an FDA registered and ISO 13485 certified medical device packaging company located in Anaheim, California. Its products are manufactured in Class 7 (10,000) & Class 8 (100,000) certified facilities with full traceability. CleanCut offers the following services and products: zero cost design and prototyping, 3D printing, HDPE pouch cards, patented “clipless dispenser" (hoops) for guidewires and catheters, pouches, labels, SBS shelf cartons, corrugated shipping boxes, tube flaring, ultrasonic welding, tube drilling/coring, tooling and production.

We ensure that you meet critical deadlines with:

  • Innovative designs and turnkey prototype samples, typically within five working days
  • Feasibility validation samples before production tooling
  • Cost-effective tooling and production runs certified with full QSR/ISO traceability to raw materials
  • Clipless Dispensers: Clipped dispensers for coiled guidewire and catheter retention and dispensing generate excessive waste, packaging bulk, and have the potential to break free during shipping and use in the OR. CleanCut Technologies’ award-winning patented one-piece Clipless Dispenser addresses these challenges with a sleek, slim and symmetrical design that is optimized for retention of a device during shipping, storage and ease of use during surgical procedures. The Clipless Dispenser material is pre-qualified for biocompatibility using HDPE and PP tubing following 2Xs 100% EtO and Gamma sterilization, and has passed three years of real-time aging. The tubing may be manufactured in various sizes and lengths from 15” to 217” to accommodate any guidewire or catheter size, and is thermally bonded for superior security without clips or adhesives. CCT also designs and supplies custom luer retention elements which ensure products are packaged safe and secure without damage.
  • HDPE Pouch Cards: CleanCut Technologies offers custom die-cut pouch cards to properly position and secure medical devices and procedural components inside a sterile pouch. Ultra-thin, light weight High Density Polyethylene (HDPE) pouch cards can efficiently replace bulky thermoformed trays to protect a device from damage and contamination. HDPE pouch cards meet the Packaging and Packaging Waste Directive (94/62/EC and 2004/12/EC) for limiting packaging weight and volume, while meeting green initiatives for the utilization of recyclable packaging materials. By design, once a card is no longer needed, it can be rolled up to a fraction of its size for ease of disposal and recycling.
  • Pouches & Tyvek Lids: Pouch-style packaging gives medical device manufacturers a superior flexible sterile barrier to protect their devices. CleanCut Technologies offers Tyvek® material, along with validated polymers and other materials for exceptional breathability and repeatable, reliable clean-peel pouch performance. The innovative structure of Tyvek® resists microbial penetration and has the flexible strength to guard against punctures from the device it’s retaining. CCT’s pouches are manufactured with precision and reliability to your exact specifications. Our servo-controlled machines produce a consistent repeatable seal, time after time. Our validated equipment has fully-adjustable rollers and sealing controls, eliminating the need for customer tooling. We can manufacture pouches up to 18” wide by 80” long without dual seal overlaps, which can sometimes lead to burn-through and other quality issues. CCT offers custom in-line pouch printing for a cleaner-looking pouch, finished in the same amount of time it takes to produce a plain pouch. Printing artwork up to 36” long directly on a Tyvek pouch versus a printed label improves branding and saves significant material and labor costs. We provide quick-turn printing requests and rapid design changes on pouches up to 80” long with non-overlapping seals.
  • SBS Cartons & Shippers: When it comes to the finished packaging of your medical device, sterility, safety, presentation and stability are paramount. CleanCut Technologies makes sure your packaging system meets and exceeds each of these requirements. In addition to HDPE pouch cards, pouches and clipless dispensers, CCT designs and offers precisely sized and complimentary SBS shelf cartons and corrugated sterilization master cartons for a total end-to-end packaging solution. All cartons are designed to reduce material footprints and can be ordered plain or with custom printed graphics and logos resulting in unique product branding. We specialize in the “hard to find” cartons ranging from 4” up to 80” in length with the controls and traceability expected from the medical device industry.
  • Design & Prototyping: The packaging elements of your medical device play a critical role in the safety and usability of the device. Inferior packaging could lead to device damage or contamination. Trust CleanCut Technologies to design innovative, efficient, safe and sterile protection for the device you’ve worked so hard to create. How does the process work? First, we’ll hold an initial information-gathering design input meeting to learn about your device and the packaging requirements for it. If your device is still in the concept-stage, no problem! We are able to create 3D prototype samples in-house based on your CAD drawings, which allow us to begin designing your packaging before the actual device is even realized. Once we have output initial CAM designs for your review, modifications can be made as required until the package design is exactly how you want it. Following initial approval, we can rapidly generate prototype samples for your final evaluation – usually within five working days. Once approved, you can order development samples to validate shipping, sterilization and final product realization requirements. Once these requirements are met, production tooling is built, first articles are submitted to you, and production begins.
  • 3D Printing: Even if your device is still in the CAD drawing concept-stage, CleanCut Technologies can start designing the packaging elements for it, putting you ahead of the game. CCT creates exceptionally accurate 3D product packaging models with our in-house 3D printer. 3D sampling for product fit verification is produced using materials such as ABS or Ultem, and we can reliably provide samples based on a customer’s confidential electronic files within 48 to 72 hours. If a project requires prototype tooling or sampling, we can produce 3D printed temporary tooling for small run jobs, instead of waiting weeks for a third-party vendor. Tooling for packaging may require multiple fixtures, and printing a tool or fixture in-house saves time, ultimately providing customers near-immediate product samples with a realistic look and feel for packaging design review.
  • Pad Printing: Pad printing is a process that transfers a 2D image onto a 3D object with a silicone pad and ink. Most medical devices require some form of pad printing for labeling, measurement indicators, part identification or branding information. There are many advantages to pad printing; it’s an inexpensive process and will yield consistent, high-quality results. Due to complicated sizes, shapes, or difficult surface materials like Silicone, Polypropylene or Polyethylene, some complex medical devices pose a challenge to print on accurately and cleanly. CleanCut Technologies offers superior pad printing for the most strictly-regulated class of medical devices in the industry. Printing is completed in a Class 8 cleanroom using stringent FDA and ISO controls.
  • Contract Manufacturing: Need a little help? CleanCut Technologies is experienced and equipped to handle contract manufacturing projects, big or small. CCT has over 90 years of combined medical device industry experience and is 100% focused on helping our customers successfully launch new products. Over 500 companies have approved CCT on their Approved Supplier lists, and our outsourcing services include: packaging concept generation, packaging design development, packaging design verification, process development, process validation/implementation and fulfillment.

Local Accessibility

CleanCut Technologies has obtained three different patents, is ISO 13485 Certified, FDA registered, and is on the ASL for over 500 medical device customers worldwide. CCT’s Clipless Dispenser was part of a Global “Best of Show Award” presented by Medtronic as part of a Packaging Waste Reduction Initiative.  

Your company deserves packaging as cutting edge as your product. We are a prompt, responsive company with on-site design and process engineers that are able to turn prototypes in a day. Green and sustainable, we not only employ the use of recyclable materials, but have met the EU Standard for Reduction in Packaging Materials by decreasing overall materials by 20 – 30%.

Come see our innovations in packaging manufacturing and how it will enhance your product’s success. We invite you to tour our Southern California facility.

CleanCut Technologies

1145 N. Ocean Circle

Anaheim Ca 92806

P:714.864.3500          F: 714.864.3595

 

Link to CleanCut Technologies MPMN Article: How a Packaging Design Firm Is Reinventing Catheter and Guidewire Dispensing

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CleanCut Technologies, LLC

http://www.cleancuttek.com
E: karen.koenes@cleancuttek.com
T: 714/864-3500
F: 714/864-3595

Address
1145 N. Ocean Cir., Anaheim, California, 92806, United States
View map

Follow  
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CleanCut Technologies, LLC

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