Medical Device Manufacturing

Capabilities and Processes

Life Science Outsourcing’s medical device manufacturing expertise is rooted in its comprehensive set of capabilities and proven processes.

Capabilities and Expertise

Our expertise establishes a level of trust with clients that enables continuous process improvement, continuous cost savings, and continuously building higher quality products. Life Science Outsourcing implements continuous needs assessment programs with our customers and potential clients, allowing our capabilities and competencies to continue to expand.

Our current core capabilities – including supply chain management – can be used across multiple product types and medical device industry segments.

Bonding Processes and Agents

Life Science Outsourcing uses several types of medical grade adhesives including:

• UV light curable adhesives
• Epoxy resins
• Cyanoacrylates

We also have curing systems to optimize the speed of automated assembly, which allows for 100% in-line inspection, and increased throughput:

• UV curing spot lamps
• Flood lamps

Mixing and Filling

Mixing and filling is a core service offered by Life Science Outsourcing. Typically, we provide our mixing and filling service as part of the full production processes for combination and biopharm products. Our mixing and filling operations are performed in a Class 100 Cleanroom.

All manufacturing and warehousing is cGMP compliant. Our ability to track a component lot code from receipt, into inventory, and then into a specific product combination, while maintaining the detailed history of each component’s movement, truly sets us apart.

 

Our featured services also include the low-cost and rapid scale-up manufacturing of Phase I pharmaceuticals and combination devices.

Packaging

Clean room packaging requires strict adherence to procedures, attention to detail, and a complete focus on quality. Life Science Outsourcing offers 10,000 square feet of Class 10,000/ISO 7 rated clean room operating space. Along with our state-of-the-art facilities, we continually invest in the newest and most advanced packaging equipment and maintain an unwavering focus on processes enhancements. Medical device manufacturers come to Life Science Outsourcing because we continually exceed expectations and strive to set the standard for excellence in the industry.

The advantages of outsourcing clean room functions include the ability to manage exceptional growth, reduced infrastructure costs, faster turnaround times, and greater workforce flexibility.

We offer a wide range of sterile packaging services as well as comprehensive packaging validation and contract sterilization and sterilization validation.

Soldering

Medical Device Soldering is a process by which two or more metal items are joined together by melting one metal (solder) into a joint of the other metal. This works due to the solder having a lower melting point then the metal used within the joint.

Soldering differs from welding in that soldering does not involve melting the work pieces. As medical devices become more complex, and electronic components play a larger role, soldering is becoming a key process used in the medical device industry.

Life Science Outsourcing has a proven proficiency with micro-soldering, with several production employees trained and certified in the process. From electronic boards to complex catheter assembly, our medical device soldering operators work with the highest quality standards to ensure your device is assembled properly every time.

Life Science Outsourcing uses several types of medical grade adhesives including:

  • UV light curable adhesives
  • Epoxy resins
  • Cyanoacrylates

We also have curing systems to optimize the speed of automated assembly, which allows for 100% in-line inspection, and increased throughput:

  • UV curing spot lamps
  • Flood lamps
Solvent Bonding

Solvent bonding is a common technique used for joining parts molded of thermoplastic resins. During this bonding process, the solvent dissolves the surface of the two mating parts and allows the material to flow together. Once the solvent evaporates, the result is material-to-material bond. Many medical device plastic-based materials can be solvent bonded in an application where ultrasonic welding won’t work.

Cyanoacrylate Adhesives

We inventory different viscosities of cyanoacrylate formulas at our facility.

Medical-grade cyanoacrylate adhesives offer exceptional product stability and faster cure speeds compared to other medical cyanoacrylate instant adhesives. This type of medical device instant adhesive can replace many different grades of both methyl and ethyl cyanoacrylates due to its ability to adhere to a wide selection of substrates.

These types of agents are:

  • Solvent Free
  • ISO 10993 approved
  • Excellent for bonding opaque and difficult-to-bond-to substrates
  • Low odor, low bloom
  • Instant adhesive bonds
  • Wide range of viscosities
UV Cure Bonding

Light-curable adhesives cure in seconds upon exposure to longwave ultraviolet light and/or visible light, heat, or with an activator. Light-curable adhesives optimize the speed of automated assembly, enable 100% in-line inspection, and increase product throughput. Industrial adhesives are available for plastic sealing, metal bonding, and glass assembly, as well as for joining dissimilar substrates.

Epoxy Resins

Epoxy resins are made of tightly linked adhesive polymer structures that are often used in surface adhesives and coatings. Epoxy resins can form tight cross-linked polymer structures characterized by toughness, strong adhesion, and low shrinkage. Epoxy adhesives are nearly unmatched in heat and chemical resistance.

Ultrasonic Welding

Ultrasonic welding (UW) is the process by which high-frequency ultrasonic acoustic vibrations are applied to two components being held together under pressure to create a solid-state weld. UW is commonly used for plastics and especially for joining dissimilar materials. In this process, there are no connective bolts, nails, soldering materials, or adhesives necessary to bind the materials together.

Life Science Outsourcing has ultrasonic welding equipment on site and is adept at developing the custom sonotrode or “horn” specific to the two components that will be bonded together.

All UW systems possess these same components:

  • Press – Applies pressure to the two components being welded
  • Nest – Where the components are placed prior to the welding process
  • Ultrasonic Stack – Consists of a converter or piezoelectric transducer, optional booster, and a horn
  • Converter – Converts the electric signal into mechanical vibration
  • Booster – Modifies the amplitude of the converter
  • Sonotrode or Horn – Applies the mechanical vibration to the parts
  • Electronic Ultrasonic Generator – a US power supply delivering a high AC frequency (Typically 20, 30, 35 or 40 kHz)
  • Controller – Controls the movement of the press.

The use of Ultrasonic welding in the medical device industry is prevalent. This equipment is usually placed in a clean room so that contaminants are not introduced. Life Science Outsourcing has produced a variety of components utilizing UW in our Class 10,000 Cleanroom, including:

  • Textile type material for implant
  • Transdermal patches
  • Mesh based material for implant
  • Plastic casing housing electronics
  • Respiratory filters

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