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Parker Hannifin Corp., Medical Systems Div.

3191 E. La Palma Ave.
Anaheim, CA 92806 USA
Tel: 714/632-7710
Fax: 714/632-5647

Web: http://www.hi-tech-group.com
E-mail: techsales@parker.com


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With annual sales exceeding $10 billion, Parker Hannifin is the world's leading diversified manufacturer of motion and control technologies and systems, providing precision-engineered solutions for a wide variety of commercial, mobile, industrial and aerospace markets. The company employs more than 57,000 people in 43 countries around 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 its Medical Systems Division, headquartered in Anaheim, California. www.hi-tech-group.com

Capabilities

Parker's Medical Systems Division is a single source solution provider to medical and pharmaceutical OEMs.

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 also offer medical grade silicone tubing, medical devices and electrosurgical instruments.

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 10,000 or Class 100,000 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."

Lean System

At Parker's Medical Systems Division, we are dedicated to the pursuit of activities and results that embrace the ideals of lean thinking. Our production and enterprise processes are based upon the Parker Lean System, which embodies the tools of Lean Fundamentals to create and standardize flow, Jidoka to drive problem solving initiatives, and Just-in-time structures that minimize material and motion waste. Furthermore, our implementation of lean thinking is driven through the most important element for assuring success, our Empowered Employees.

We utilize value stream mapping for our production lines and administrative processes to determine how products and services are received, processed, and delivered to our internal and external customers. With this knowledge we perform kaizen based improvement events to seek and eliminate wasteful practices, and to add value as it is seen in the customer's eyes. We believe in utilizing standard work and problem solving methodologies to create baseline processes and continually improve upon the quality and productivity of our products and services. Through the continual practice of lean, we are driven to engineer your success.

Quality System

Parkers Medical Systems Division manufactures class III medical devices and as such, our quality system has been rigorously inspected by the FDA.

MSD's system is designed to allow easy integration into or in conjunction with our customer's systems. We have assisted many of our start-up clients put together a quality system which is right for their business.

Design Control & Clinical Trial Builds

Parker's Medical Systems Division frequently produces product for our customers' clinical trials. Depending on the size and scope of the trial, we can manufacture a single lot of less than one hundred units up to multiple lots of several thousand pieces. As we have design control as one of the elements of our quality system, we can provide significant guidance and assistance in helping you work through this element of the development process.

Parker Medical Systems Division can assist in writing marketing specifications, product specifications, validation protocols, assembly procedures and packaging specifications. We can also prepare component drawings, design labeling, design tooling and fixtures, perform risk analysis, facilitate failure modes effect analysis, conduct first article inspections, carry out product validations, coordinate sterilization validation and structure and compile the design dossier.

MEDICAL DEVICE & INSTRUMENT ASSEMBLY

SILICONE MEDICAL DEVICE ASSEMBLY

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 10,000 or Class 100,000 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

GENERAL MEDICAL DEVICES

Parker's Medical Systems Division 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

MEDICAL COMPONENT MANUFACTURING

LIQUID SILICONE MOLDING

http://www.hi-tech-group.com/liquid_silicone_molding.html

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 implantable grade silicone, 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 10,000 or Class 100,000 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."

THERMOPLASTIC & TPE MOLDING

We offer medical OEM's 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 100,000 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 10,000 or Class 100,000 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."

FLASHLESS ORGANIC AND SILICONE 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.

ORGANIC RUBBER INJECTION MOLDING

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 and Indiana.

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."

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

LOCATIONS

Parker's Medical Systems Division has manufacturing facilities s located in California and Indiana. Parker also has medical manufacturing facilities in Singapore and China.

CONTACT INFORMATION

Parker Hannifin Corporation
Seal Group
Medical Systems Division
3191 E. La Palma Avenue
Anaheim, CA 92806 USA
phone 714-632-7710
fax 714-632-5647
Techsales@parker.com
www.parker.com | www.hi-tech-group.com | 800-924-4832


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