With annual sales exceeding $12 billion, Parker Hannifin is the world's leading diversified manufacturer of motion and control technologies and systems,. The company employs more than 57,000 people in 43 countries around the world, with over 300 manufacturing facilities throughout the world. In April 2008, Parker Hannifin acquired the Hi-Tech Group, which consisted of Hi-Tech Rubber, A. C. Hoffman Engineering, Inland Technologies, Ventrex, and Accusil, and designated it as Parker’s Medical Systems Division, headquartered in Anaheim, California.

The Medical Systems Division (MSD) is a single source solution provider dedicated to servicing the global medical device, diagnostic and pharmaceutical OEM market. MSD’s core competencies include

• Liquid Silicone Injection Molding (LIM)
• Silicone/Organic Injection & Flashless Molding
• Thermo-plastic Injection Molding
• Medical Grade Silicone Extrusions & Tubing
• Medical Device Fabrication, Assembly & Packaging
• Electro-Mechanical Instrument Design, Assembly & Packaging

Manufacturing is performed in one of our six ISO 13485 certified facilities in California, Indiana or Tijuana, Mexico. Our medical device manufacturing facilities in Ventura, California and Merrillville, Indiana are also FDA registered for finished device assembly and packaging. Depending on the OEM customer specified requirements, we can mold or assemble a majority of components in either our ISO Class 7 Class 8 clean rooms. Additional MSD capabilities include on-site Finite Element Analysis (FEA) and trace metal analysis as well as a working knowledge of FDA, cGMP, USP Class VI and ISO 10993 materials and standards. Our experience with Class 1, 2 and 3 devices allows MSD to move from prototype to production – quickly and cost effectively.

MEDICAL COMPONENT MANUFACTURING

LIQUID SILICONE INJECTION MOLDING(LIM)

With extensive in-house prototype and production tooling capabilities, we offer medical and pharmaceutical OEMs a wide range of medical grade contract-molding services by way of liquid silicone injection molding (LIM/LSR), silicone injection & flash-less-molding, organic rubber injection & flash-less molding, compression molding as well as extensive thermoplastic and TPE injection molding at its six medical contract manufacturing facilities in California and Indiana.

Parker’s Medical Systems Division uses tested and certified medical and short term (29 days or less) implantable grade silicone rubbers, thermoplastic and TPE base materials from the key material suppliers for molding its elastomeric medical components. We also offer our customers customized material formulations whenever necessary per the OEM's specific functional requirements.

All of our contract-molding is done in ISO 9001:2000 certified facilities. Depending on the OEM's specified requirements, we mold the components in either Class 7 or Class 8 clean rooms. Implantable components and devices are molded, assembled and fabricated in one of our FDA Registered, ISO 13485 facilities. Non-critical components are molded in one of our clean "white-rooms."

SILICONE/ORGANIC INJECTION & FLASHLESS MOLDING

With press sizes up to 500 tons, Parker’s Medical Systems Division provides extensive capabilities for medium to high-volume silicone and organic rubber Flashless Transfer Molding with proprietary high-cavitation tooling.

With extensive in-house prototype and production tooling capabilities, we offer medical and pharmaceutical OEMs organic rubber injection and compression its medical contract manufacturing facilities in California, Indiana and Tijuana, Mexico.

All of our contract-molding is done in ISO 9001:2000 certified facilities. Implantable components and devices are molded, assembled and fabricated in one of our FDA Registered, ISO 13485 facilities. Non-implantable and other non critical components are molded in one of our clean "white-rooms."

THERMOPLASTIC & TPE MOLDING

Our Fontana CA facility offers medical OEM customers the following thermoplastic and thermoplastic elastomer injection molding capabilities:

• High-precision, tight tolerance thermoplastic injection molding and insert molding.
• ISO-9001:2000 & ISO-13485 Certified.
• Presses ranging from 25 tons to 400 tons.
• In-house prototype & production tool design & building.
• Class 8 Clean Rooms.
• Material selection includes:
  • Polycarbonate
  • LCP
  • ABS
  • Acetal
  • Polypropylene
  • Polyethylene (LLDPE, LDPE, HDPE)
  • Nylons including Glass Filled
  • Ultem
  • PEEK
  • Teflon
  • Acrylic
  • Carbon Fiber Composites
  • EVA
  • Thermoplastic Elastomers to 5 Shore A
  • Polystyrene
  • PVC

INSERT & OVER-MOLDING

With extensive in-house prototype and production tooling capabilities, Parker’s Medical Systems Division offers medical and pharmaceutical OEMs a wide range of medical grade contract-molding services by way of liquid silicone injection molding (LIM/LSR), silicone injection & flash-less-molding, organic rubber injection & flash-less molding, compression molding as well as extensive thermoplastic and TPE injection molding at its six medical contract manufacturing facilities in California and Indiana.

We use tested and certified medical and implantable grade silicone, thermoplastic and TPE base materials from the key material suppliers for molding its elastomeric medical components. Parker Medical Systems Division also offers its customers customized material formulations whenever necessary per the OEM's specific functional requirements.

All of our contract-molding is done in ISO 9001:2000 certified facilities. Depending on the OEM's specified requirements, we mold the components in either Class 7 or Class 8 clean rooms. Components and devices are molded, assembled and fabricated in one of our FDA Registered, ISO 13485 facilities. Non-critical components are molded in one of our clean "white-rooms."

MEDICAL GRADE SILICONE EXTRUSIONS

With in-house tooling capabilities, we offer OEMs a wide range of medical grade single and multi-lumen tubing and extruded profiles.

Single & Multilane tubing

X-ray striped & X-ray opaque tubing

Wire-reinforced tubing

Profiled tubing & rods

Color coded tubing & rods

On-line cutting to length & 50 ft. coils

Continuous laser monitoring of tubing size during extrusion

Medical grade silicones from all major suppliers

Custom and standard sizes

MEDICAL DEVICE FABRICATION, ASSEMBLY & PACKAGING

Parker’s Medical Systems Division can do extensive silicone device assembly, fabrication, and packaging at our FDA Registered ISO 13485 certified manufacturing facilities. We contract manufacture the following types of silicone devices in either Class 7 or 8 certified Clean Rooms:

• Cardiovascular Catheters
• Endotracheal Catheters
• Feeding Catheters & Devices
• Multi-port Urological Catheters
• Nasal Airways with single & dual balloons
• Orthopedic devices
• Pediatric Catheters
• Peritoneal Dialysis Catheters
• Surgical Wound Drainage tubes
• Trachestomy Catheters Wire-reinforced Diagnostic catheters

ELECTRO-MECHANICALINSTRUMENT DESIGN, ASSEMBLY & PACKAGING

The Medical Systems Division Ventura, CA facility http://ventrexinc.com/ is a single source FDA registered and ISO 13485 certified finished medical device engineering & manufacturing firm, offering single use devices, non-sterile reusable devices and in-vitro diagnostic assembly, testing, packaging, sterilization and distribution.

Class I, II and III medical devices:

• Critical Care
• Cardiology
• Operating Room
• Cardiac Cath Lab
• Respiratory Therapy
• Emergency Room
• Neurology
• Oncology
• Labor and Delivery
• Chronic Care
• Clinical Laboratory
• Sleep Labs
• Audiology

Assembly processes include:

• Ultra-precision, precision & standard assembly
• Electro-mechanical assembly
• Catheter assembly
• Nitinol wire forming
• Thermal tip forming
• Solvent & cyanoacrylate bonding
• UV adhesive, epoxy & polymer adhesive bonding
• P.C. board assembly
• Precision & standard soldering
• Fiber optic processing including lens forming & polishing, bonding, gapping, cladding, polishing & fiber pyrolizing
• Flow, leak & tensile testing
• Glass forming
• Controlled siliconizing & silicone dispersion coating
• Gold wire bonding
• Hermetic seam welding
• Electro-static bonding
• Ultra-sonic welding
• Thermal welding & staking
• Micro riveting
• Micro arc welding
• Ultra-sonic cleaning
• Automatic & semi-automatic software controlled testing
• Electro-mechanical testing
• Packaging including pouch, pre-formed trays & form-fill-seal
• Sterilization including ethylene oxide & irradiation

Front End Design Assistance

• Design for manufacturability analysis
• Plastic part design
• Material selection
• Rapid prototyping
• Prototype injection molds for low cost design verification
• Sterile package design
• Shelf and shipping box design and configuration

Process Development and Validation

• Assembly process definition and design
• Test procedure definition and design
• Tooling and fixture design and fabrication
• Equipment validations including I/Q, O/Q and P/Q
• Design of Experiment
• Validation protocol development, testing and reports
• Sterile package seal strength characterization
• Sterilization validation
• Accelerated age studies
• Transit testing

Material Procurement and Control

• Vendor identification
• MRP inventory management
• Component purchasing
• Receiving inspection
• Component and sub-assembly warehousing
• Full lot control

Product Manufacturing

• Full lot control and/or serialization
• In-process and final quality assurance
• Sterile packaging in all standard formats
• Sterilization coordination including QDA's and annual EO revalidations
• Final packaging

Device History Record/Master Record

• Complete device manufacturing documentation
• Complete work order history
• Full lot control

MEDICAL INSTRUMENTATION

Parker’s Medical Systems Division offers highly responsive assembly and testing of medical instrumentation ranging from relatively simple electro-mechanical devices to highly complex multi-technology integrated systems.

Core assembly and test competencies include:

• Sensors
• Pneumatics
• Hydraulics
• Controls and control circuitry
• Actuators
• Steppers
• Servos
• Mother boards and displays
• Hard drives
• Power supplies and special purpose PCB's
• Harnesses
• Lead screws
• Drive gears
• Sheet and machined metal
• Plastic and metal enclosures

Core assembly and test competencies include:

• Sensors
• Pneumatics
• Hydraulics
• Controls and control circuitry
• Actuators
• Steppers
• Servos
• Mother boards and displays
• Hard drives
• Power supplies and special purpose PCB's
• Harnesses
• Lead screws
• Drive gears
• Sheet and machined metal
• Plastic and metal enclosures

Please click n the following PARKER link for additional information:

Click here for copies of PARKER MSD’s Technical bulletins

E-mail: msdtechsales@parker.com