Elastomer Molding Capabilities
We manufacture medical grade products that meet quality requirements and customer dimensional specifications in ISO 13485 facilities in Mexico, California, and Indiana in either clean environment or ISO Class 8 cleanrooms.
Parker specializes in medium to high volume liquid silicone injection molding, conventional high consistency silicone rubber and organic rubber injection molding and compression molding.
We process commercial medical grade silicone base materials, proprietary formulations as well as custom compounded materials.
Liquid Injection Molding (LIM/LSR)
With presses ranging in size from 28 tons to 300 tons, we provide medium- to high-volume semi-automatic, automatic cold-runner and conventional runner liquid injection molding (LIM/LSR) of components and finished devices to medical and life science customers.
Injection & Compression Molding
Our competency includes complete capabilities to mold horizontal and vertical high consistency rubber silicone and organic rubber by way of injection and compression molding methods.
We also perform high volume organic rubber ‘flashless” vacuum transfer molding with proprietary high-cavitation tooling. Medical components are manufactured in either a clean environment or in ISO Class 8 cleanrooms.
Molded Materials
In addition to commercial medical silicones, we can provide custom compounds and proprietary formulations from medical grade base materials that include:
- Silicone
- Gum silicone
- High consistency rubber
- EPDM
- Nitrile
- Organics
- USP <381> compliant polyisoprene
- Standard polyisoprene
Applications
- Elastomer enclosures for drug delivery and infusion septa
- Patient care
- Respiratory and anesthesia
- Diagnostic and lab equipment
- Pharmaceutical bioprocess manifolds
- Cardiovascular treatment and intervention
- Surgical instruments ranging from simple electro-mechanical devices to highly complex multi-technology systems
Thermoplastic Injection Molding
With horizontal and vertical molding presses ranging from 28 tons to 500 tons, we offer medium-to high-volume injection and insert molding of precision components in a range of commercially available engineered thermoplastics.
Insert and Overmolding
Parker offers medium to high volume insert and over-molding capabilities including plastic inserts, metal inserts (wire, tubing, needles), organic rubber, silicone and suture thread.
As a process driven lean enterprise, we work alongside customers to thoroughly identify and and resolve issues to achieve smooth transition from concept to production, assembly, and successful launch.
Embedded RFID
For product identification, tracking, anti-counterfeiting, or where compliance with the machine-readable requirement of the U.S. FDA's Unique Device Identifier (UDI) Final Rule is needed, Parker has proven and patented techniques for embedding RFID technology into molded medical components during fabrication.
Thermoplastics Materials
Our thermoplastics offering includes:
• ABS
• Acrylic
• EVA
• Nylon
• Polycarbonate
• PE
• PPE
• PPSU
• PEEK
• PVC
• TPE/ TPU
Applications
- Medical device components
- Device enclosures and handpieces
- Vascular access connectors
- Surgical instruments and manipulators
- Respiratory equipment
- Cardiology devices
- Gastrointestinal devices
- Laparoscopy equipment
- Diagnostic equipment
Extrusions
With in-house extrusion capabilities, we offer biomedical and pharmaceutical OEMs a wide range of medical grade single and multi-lumen tubling as well as x-ray opaque extrusions and radiopaque striping.
We specialize in both medical grade silicone and non-occluding coil wire reinforced (spring encapsulated) silicone tubing used in a variety of applications.
Common Sizing and Custom Configuration
Tubing and extruded profiles are manufactured to your dimensional specifications. The most commonly used medical grade tubing sizes as well as custom-sized tubing with ID's ranging from 0.012" to 1.0" are available with desired wall thickness.
Tubing can be extruded and cut to length to your specific application needs and custom configured to include printing, striping, punching, and finished assembly.
USP Class VI Formulations
Extrusions are provided in either peroxide and platinum-cured formulations from materials that meet USP Class VI standards and ISO Class 8 cleanrooms. They are compatible with autoclave, ethylene oxide, or gamma radiation sterilization methods.
Extrudable Materials
Our materials offering includes:
- Medical grade silicone
- Radiopaque formulations
- Peroxide and platinum cured formulations
- Overmolded, non-occluding coil-wire reinforcement
Applications
- Peristaltic pumps
- Multi-lumen catheter mainshafts
- Wound drainage tubes
- Enteral feeding catheters
- Spring-reinforced catheters
- Peritoneal dialysis catheters
- Tracheostomy tubes
- Foley catheter mainshaft and cuffs
- Vascular loops
- Cannula
- Drug delivery
USP Class VI
Medical Materials
For healthcare and life science applications, we offer biomedical and pharmaceutical OEMs a wide range of medical grade materials that meet USP Class VI requirements for biocompatibility, including thermoplastics, silicone elastomers, and USP <381> compliant Polyisoprenes
Processing Methods
What mechanics are involved in the different methods of manufacture of medical silicone products?
Read the high level discussion illustrating three different methods of manufacture for silicone medical products: profile extrusion, compression molding, and injection molding.
