QUALITY ASSURANCE GLOBAL SOLUTIONS · the industry with all-electric injection molding machines,...
Transcript of QUALITY ASSURANCE GLOBAL SOLUTIONS · the industry with all-electric injection molding machines,...
Specialists in Precision Plastic Manufacturing for Medical
• PRECISION PLASTIC BALLS AND MEDICAL COMPONENTS
• CLEAN ROOM INJECTION MOLDING • ASSEMBLY • PACKAGING
Hoover Precision Products, LLC
Hoover Precision Products, LLC.1390 Industrial Park Dr. | Sault Ste. Marie, MI 49783
P: 906-632-7310 | F: 906-632-7555 | E: [email protected]
Parent Company &Manufacturing Plant
Tsubaki Nakashima Co., Ltd.19 Shakudo Oaza Taimacho
Kita-Katsuragi-Gun, Nara 639-2163Tel: 81-74548-8072 Fax: 81-74548-8073
www.tsubaki.com
US Corporate HeadquartersManufacturing Plant and Distribution Center
Hoover Precision Products, Inc.2200 Pendley Road
Cumming, GA 30041Tel: 770-889-9223 Fax: 770-889-0828
www.hooverprecision.com [email protected]
Hoover’s plastic production plant is only an hour’s flight north of Detroit Metropolitan Airport in Michigan’s Upper Peninsula. Shipping to medical OEMs around the world, the Michigan facility services the industry with all-electric injection molding machines, secondary process equipment, advanced metrology lab and a highly skilled and experienced workforce dedicated to providing quality plastic parts while maximizing value.
TSUBAKI-HOOVER PLANTS AROUND THE WORLD, PROVIDE ACCESS TO A GLOBAL NETWORK OF MANUFACTURING SOLUTIONS.
Quality, on time delivery and trust are the key ingredients to maintaining a positive relationship with our customers. It serves as our driving force for obtaining new business, maintaining our reputation in the marketplace and is the commitment of our organization. Through our commitment to continuous improvement, we will continue to provide the highest quality at the lowest possible cost.
Certificate of RegistrationThis certifies that the Quality Management System of
Hoover Precision Products, L.L.C.1390 Industrial Park Drive
Sault Ste. Marie, Michigan, 49783, United States
has been assessed by NSF-ISR and found to be in conformance to the following standard(s):
ISO 9001:2008
Scope of Registration:Design For Manufacturing (customer design inputs) and the manufacturing of injection molded plastic components in a cleanroom environment for the medical device industry and the manufacturing of precision balls of various metals, ceramics and
thermoplastics as well as injection molded components for various industries.
Carl Blazik,Director, Technical Operations & Business Units,NSF-ISR, Ltd.
Certificate Number: 2Y331-IS5Certificate Issue Date: 22-JUL-2015Registration Date: 14-APR-2014Expiration Date *: 13-APR-2017
GLOBAL SOLUTIONS
QUALITY ASSURANCE
Certificate of RegistrationThis certifies that the Quality Management System of
Hoover Precision Products, L.L.C.1390 Industrial Park Drive
Sault Ste. Marie, Michigan, 49783, United States
has been assessed by NSF-ISR and found to be in conformance to the following standard(s):
ISO 13485:2003
Scope of Registration:Design for manufacturing (customer design inputs) and the manufacturing of injection molded
plastic components in a clean room environment for the medical device industry.
Carl Blazik,Director, Technical Operations & Business Units,NSF-ISR, Ltd.
Certificate Number: 2Y331-MD5Certificate Issue Date: 22-JUL-2015Registration Date: 14-APR-2014Expiration Date *: 13-APR-2017
Plastic Ball Grades Grade Devia�on from
Spherical Form Nominal Ball
Diameter Tolerance Surface Finish
0 .0005” +/‐.0005” Polished
I .0005” +/‐.001” Polished
IIP .001” +/‐.002” Polished
II .001” +/‐.002” Unpolished
III .005” +/‐.005” Unpolished
PRECISION INJECTION MOLDINGAs an industry leader in plas�c balls for medical applica�ons, we contract injec�on mold other (non‐spherical) disposable components in our Class 8 Compliant Cleanroom to support the medical industry. We specialize in high quality, price compe��ve, plas�c medical parts such as specialized plas�c tubes, petri dishes and other plas�c disposables. We employ modern injec�on molding and clean room technology with advanced skills where �ght tolerance, clarity, light transmi�ance and lot‐to‐lot integrity are necessary product characteris�cs. We will work with your company on developing automa�on to run your products as efficiently as possible.
Streamlined Efficiency In recent years, a 42,000 sq. �. newly built addi�on was added to the manufacturing plant with an addi�onal 8,000 sq. �. clean room with state‐of‐the‐art equipment along with a larger mold maintenance area and increased on‐site warehousing space. Our raw materials and nished goods are contained in controlled areas within our �ghtly secured warehouse. We can offer quality short run and intermi�ent produc�on to full produc�on volumes.
QUALITY ASSURANCE Quality, on �me delivery and trust are the key ingredients to maintaining a posi�ve rela�onship with our customers. It serves as our driving force for obtaining new business, maintaining our reputa�on in the
GENERAL ASTM Method AcetalAcrylic
(Polyoxymethylene) Nylon (Polyamide) Polyamide-imide Polycarbonate HD PolyethyleneLD
Polyethylene Polypropylene Polystyrene Polycarbonate Polytetrafluoroethylene
Specific Gravity D792 1.42 1.19 1.14 1.38 1.2 0.96 0.91 0.9 1.05 1.2 2.14 - 2.24
Water Absorption(method A, 24hr)% D570 0.25 0.3 1.2 0.15 0.2 0.15 0.01
Tensile Strength 11.2
at Yield, 1000 psi D638 10 10.5 12 27.8 9 4.2 1.35 5.07 7.5 8-9.5 2.5-6
Compressive Strengthat Yield, 1000 psi D695 5.2 17 32.1 12.5 11
Rockwell Hardness M94 R121 M70 M70
(Method A) D785 R120 M96 R108 E86 R118 99 M75 R118 D50-D65
THERMAL & ELECTRICAL
Deflection
Temperature, °F D648 212
At 66 psi
Fiber Stress 342 201 455 280 200
At 264 psi
Fiber Stress 277 199 194 532 270
Max. Recommended
Service Temp., °F 180 185 450 240 550*(288)
Coeff. of Linear
Thermal Expansion, °F D696 5.8E-5 3.5E-5 4.9E-9 17E-6 3.8E-5 5.5 x 105
CHARACTERISTICS
Abbreviation POM PMMA PA PAI PC HDPE LDPE PP PS PC PTFE
Trademarked Materials Celcon®, Delrin® Plexiglas™ Zytel® Torlon® Lexan® Pro-Fax® Lexan® Teflon®
Trademarked Manufacturers Ticona, Dupont Altuglas Dupont Solvay SABIC Chevron Phillips Dow Lyondellbasell Ineos Nova SABIC Dupont
YES YES YES YES (Virgin)
*Equivalents may be used unless specific trademarked material is specified by customer
FDA Compliant YES YES
Natural Color:
Polished White Clear Off White Green Clear Off White Off White White Clear Clear White
Unpolished White-Frosted Frosted Off White Green Frosted Off White Off White Frosted Frosted Frosted White
Process Injection Injection Injection Injection Injection Injection Injection Injection Injection Extruded Extruded
Molded Molded Molded Molded Molded Molded Molded Molded Molded Rod Rod
Common Applications CastersCheck Balls
Drawer glidesMarine Hardware
Seat TracksSeatbelt RetractionSoap Dispensers
Spray PumpsTrigger Sprayers
CosmeticJewelry
ToysBeads
Drawer glides CastersCheck Balls
Drawer glidesMarine HardwareSailboat blocksSailboat pulleys
Seat TracksSeatbelt Retraction
Bearing Medical Devices Check ValvesGames
Plug BallsMedical Device
Beads
Enzyme Immunoassay (EIA)
Radioimmunoassay (RIA) Medical Diagnostic
Medical Device
Bearing Check BallsMedical Devices
Disclaimer: Information is provided for comparison purposes only and not to be used as a recommendation for any engineered product.
Plastic Data
BEADS TAILORED FOR RESULTSSolid plastic beads can be manufactured to OEM specifications, with typical size range between 1/16” and 5/16” diameter. Bead selection for enzyme immunoassay and radioimmunoassay applications, starts by determining the optimal surface roughness for the specific test being designed. Small quantity product samples can be provided for testing to help determine the characteristics that work best for the application. Other finishes can also be customized. Beads can be molded from polystyrene or other specified plastic per customer requirements. Beads can also be irradiated for sterilization upon request. Customers typically develop a washing protocol prior to coating the beads.
BALLS FOR MEDICAL DEVICE APPLICATIONSPlastic balls from 1/16” up to 1” and larger are employed in a wide variety of medical device applications for plugs, mixing, check valves, and bearings to mention a few. Our team will work with your design engineers to assist in determining the best material, size and grade for your application. Special colors, engineered plastics and grades can be tailored to suit your requirements. FDA compliant and 100% virgin materials can be used on request. In addition to plastics, we also offer stainless, metal alloy, and ceramic balls to ABMA/ISO Standards and special grades for use in medical devices.
FLEXIBLE LOT SIZE CAPABILITY AND TRACEABILITYRecognizing the critical importance of lot traceability and product verification for the medical and diagnostic industries, complete documentation and certification for all materials and manufacturing lots is assured. With flexible production capabilities, we can provide balls in lots from 1,000 to 2,300,000 piece batches depending on particular size and material.
SURFACE ANALYSISPRECISION INJECTION MOLDING As an industry leader in plastic balls for medical applications, we contract injection mold other (non-spherical) disposable components in our Class 8 Compliant Cleanroom to support the medical industry. We specialize in high quality, price competitive, plastic medical parts such as specialized plastic tubes, petri dishes and other plastic disposables. We employ modern injection molding and clean room technology with advanced skills where tight tolerance, clarity, light transmittance and lot-to-lot integrity are necessary product characteristics. We will work with your company on developing automation to run your products as efficiently as possible.
STREAMLINED EFFICIENCYIn recent years, a 22,000 sq. ft. newly built addition was added to the manufacturing plant with an additional 8,000 sq. ft. clean room with state-of-the-art equipment along with a larger mold maintenance area and increased on-site warehousing space. Our raw materials and finished goods are contained in controlled areas within our tightly secured warehouse. We can offer quality short run and intermittent production to full production volumes.
Hoover Precision Products is committed to serving medical diagnostic and biotechnology firms worldwide. Manufacturing precision made, custom produced beads for use in diagnostic, protein purification, research and development, and medical device applications with capability to provide supported injection molded components in our state of the art class 8 Compliant clean room.