Medical Design Briefs.Pdf

Total Page:16

File Type:pdf, Size:1020Kb

Medical Design Briefs.Pdf Welcome to your September 2020 Digital Edition of Medical Design Briefs and Medical Manufacturing & Machining Medical Design Briefs Medical Manufacturing & Machining www.medicaldesignbriefs.com September 2020 September 2020 Maximizing Throughput, Speed, and Efficiency with Robotics Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing for COVID-19 Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders Low Latency Manufacturing in Electronics in Electronics for Medical Device Packaging COVID-19: Increasing Ventilator Display Mount Production Supplement to Medical Design Briefs From the Publishers of Click Here Click Here How to Navigate the Magazine: At the bottom of each page, you will see a navigation bar with the following buttons: Arrows: Click on the right or left facing arrow to turn the page forward or backward. Introduction: Click on this icon to quickly turn to this page. Cover: Click on this icon to quickly turn to the front cover. Table of Contents: Click on this icon to quickly turn to the table of contents. Zoom In: Click on this magnifying glass icon to zoom in on the page. Zoom Out: Click on this magnifying glass icon to zoom out on the page. Find: Click on this icon to search the document. You can also use the standard Acrobat Reader tools to navigate through each magazine. We’ve Added More Value-Added To Our Added Value! What, the best technology and best service aren’t enough for you? The recognized world leader in medical-grade foot switches (both wireless and cabled) offers you so much more: • FreeRTQFWEVUCORNGUVQSWCNKƂGFDW[GTU • Free consultation • Free customization options to avoid creating new tools • An unprecedented 2-year warranty • 30+ off-the-shelf designs that satisfy most medical requirements • 'CUKGTYKTGNGUUKPVGITCVKQPVJCPMUVQEGTVKƂECVKQPCPFVGUVTGRQTVU • Important documentation package services for wireless, for example: - Risk Management Plan/Report 2TGRCTCVKQPQHEQPHQTOKV[ƂNGUVTCEGCDKNKV[OCVTKZ(/'#TKUMCPCN[UKUGVE - Meets the requirements of software safety class C (per EN 62304) With all these advantages, why not give us a try? www.steutemeditech.com/worldclasswireless Direct Contact: Maurizio Lauria, Brand Manager 203.244.6302/[email protected] MKF 2 SW2.4LE-MED GP211 www.medicaldesignbriefs.com September 2020 Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing forYLKLÄUPUN[OLSPTP[Z COVID-19 VML_[Y\ZPVU[LJOUVSVN` Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders in Electronics in Electronics www.microspecorporation.com 327 JAFFREY RD ࠮ PETERBOROUGH, NH 03458 ࠮ USA +1 603-924-4300 ࠮ [email protected] the Publishers of YLKLÄUPUN[OL SPTP[ZVML_[Y\ZPVU [LJOUVSVN` ࠮5,>*65*,7;: ࠮:05.3, 4<3;03<4,5;<)05. ࠮)<47;<)05. ࠮*6,?;9<:065: ࠮40*96,?;9<:065: ࠮796-03,,?;9<:065: ࠮*6(;,+>09, ࠮;90,?;9<:065: ࠮4<3;03(@,9,+,?;9<:065: ࠮-<33@,5*(7:<3(;,+:;907,: ࠮6=,9,?;9<:065: ࠮)(33665;<)05. ࠮05;,940;;,5;4<3;0+<964,;,9,?;9<:065: ࠮90))65,?;9<:065: www.microspecorporation.com 1(--9,@9+ 7,;,9)696<./5/࠮<:( [email protected] 13485 Free Info at http://info.hotims.com/76507-732 www.medicaldesignbriefs.com September 2020 Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing for COVID-19 Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders in Electronics in Electronics From the Publishers of NEW GENERATION You’ve never seen a solenoid valve like this before. ® High Flow, Low Power, Low Leakage Across an Extensive Cycle Life The Lee Company is excited to announce a new generation of versatile and innovative 3-port solenoid valves. In a miniature 10mm package, the genvi® solenoid valve platform features high flow capacity, low leakage and ultra-low power consumption. Designed using innovative manufacturing techniques, this new valve offers not only unmatched reliability, but also an economical price point suitable for molecular diagnostics, respiratory therapy, compression therapy, environmental monitors, breath analyzers and other applications where performance and reliability are paramount. When designing portable or stationary instruments, OEMs are often challenged with meeting aggressive size, power, and weight limitations, all without sacrificing the remaining elements of system-level performance. Each subcomponent is therefore pushed to offer improved performance within a smaller footprint. Featuring high flow and low power consumption, genvi solenoid valves are the solution. An extremely tight leakage rating reduces compressor demand and further underscores the valve’s ability to provide consistent long-term operation across an extensive cycle life. Custom valve solutions, supported by The Lee Company’s Innovation in MiniatureÊ engineering experience in microfluidics, are also available ® to meet specific application requirements. The Lee Company 2 Pettipaug Rd Westbrook CT 06498-0424 860-399-6281 | 1-800-LEE-PLUG www.theleeco.com W E S T B R O O K • L O N D O N • P A R I S • F R A N K F U R T • M I L A N • S T O C K H O L M Free Info at http://info.hotims.com/76507-733 1 1/8/20 3:48 PM MADE IN THE U.S.A. Interpower® North American & International Hospital-Grade Cords With 1-Week U.S. manufacturing Lead-Times on non-stock • Quantity price breaks available with Interpower products, and Same Day Shipping on in-stock blanket or scheduled orders products, reliable power is readily available to critical medical facility patients, families and staff. Whether a city hospital or a • No minimum order or dollar country clinic, Interpower manufactures hospital-grade power requirements cords and cord sets to hospital-grade specifications and ships • Value-added options, e.g., colors, them on time! lengths, packaging and labeling When designing, building, and maintaining hospital-grade products to be used worldwide, it is important to know the medical requirements of the country of export. In addition, select Resource Links: hospitals have proprietary requirements. Special consideration is needed for products used in Australia, Canada, Denmark, Japan, Interpower Shipping __ and the United States. Product Info Questions? Interpower offers free technical support to both beginners and experts to help you find exactly what you need. Guides and Charts White Papers ® Order Online! ® www.interpower.com Business Hours: 7 a.m.–6 p.m. Central Time INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 | Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | [email protected] Free Info at http://info.hotims.com/76507-734 September 2020 Published by Tech Briefs Media Group, an SAE International Company COLUMN SPECIAL SECTION 4 From the Editor Technology Leaders in Electronics 20 Thin Film Electrodes Show Potential for Transforming FEATURES Neurosurgery 8 Medical Device Package Testing: Developing a Test Plan 25 When Every Second Counts … Important Considerations that Avoids Product Launch Delays for Respiratory Ventilator Design 12 Are You Ready for the Next UDI Deadline? 28 How Unlimited-Length Flexible Printed Circuits Are 16 Adapting Under COVID: Expansion and Implementation of Transforming Electrical Interfaces in Medical Devices PPE Testing ON THE COVER TECH BRIEFS Plasma treatments help eliminate air bubbles that can accumulate and thus interfere with the proper mixing of 36 Temporary COVID-Specific Treatment and Testing Facilities reagents. To learn about the role of plasma treatments in Require Distinct Interconnect Solutions modifying the surface of the plastic multi-well cartridges 38 Four Critical Challenges of Prehospital Infusion used in COVID-19 testing, read the article on page 44. (Credit: PVA TePla) 40 New Wearable Sensor Tracks Vitamin C Levels in Sweat 41 Spinal Stimulators Repurposed to Restore Touch in Lost MEDICAL MANUFACTURING & Limb MACHINING (Selected editions only) 42 Robotic Arm Helps Perform Delicate Surgeries 1a Low Latency Manufacturing for Biophotonics and Medical 44 Fast-Tracking Diagnostic Testing for COVID-19 and Other Device Packaging Viruses 6a An Inside Look at Maximizing Throughput, Speed, and Efficiency with Robotics in Medical Device Manufacturing DEPARTMENTS 9a Case Study: Increasing Ventilator Display Mount 34 R&D Roundup Production to Meet COVID-19 Demands 46 New Products & Services 11a New Approach to Fastener Design Prevents 49 Advertisers Index Loosening in Medical Devices 50 Global Innovations 13a Tech Briefs (Credit: Stäubli Tec-Systems GmbH Robotics) 2 Fr ee Inf o at h tt p : //inf o. h ot ims . c o m/76 50 7-7 35 Medical Design Briefs, September 2020 We invented CYROLITE® over 40 years ago – and we’ve used the time ever since to perfect its properties. The result is highly advanced acrylic polymers that boast outstanding optical properties such as superior UV trans- mittance. At the same time, CYROLITE® offers excellent fl ow properties, thus enabling them to be molded into extremely thin-walled components. It goes without saying that CYROLITE® meets all the relevant USP Class VI, ISO 10993-1, and REACH standards. For more So clear it’s like it’s not even reasons why CYROLITE® is the clear choice, here: highly transparent visit www.cyrolite.com. CYROLITE® for diagnostic applications. Free Info at http://info.hotims.com/76507-736 FROM THE EDITOR Device Companies Seek M&A Barometer,
Recommended publications
  • The Dupont Tyvek® Medical Packaging Transition Project – Collaboration with the Radiation Processing Industry
    THE DUPONT TYVEK® MEDICAL PACKAGING TRANSITION PROJECT – COLLABORATION WITH THE RADIATION PROCESSING INDUSTRY Selena Qin Nov 7 2013 IRRADIATION FOR LIFE: Safe, Green and Growing Medical Packaging Transition Project (“MPTP”) Objective – To Ensure Continuity and Flexibility of Future Supply • Goal of the Transition Project is to demonstrate functional equivalence of Styles 1073B and 1059B • Functional equivalence means that the attribute you are measuring may be different, even statistically, but it still meets functional and performance requirements, so that it will perform similarly to current Tyvek® in your process and applications • More than $30 Million investment by DuPont covering: – Global regulatory and industry support – Raw materials for multiple line and polymer testing – Developmental package creation and testing – Transition Protocol package creation and testing – Third-party laboratory testing – Phantom Protocol – Product Stewardship IRRADIATION FOR LIFE: Safe, Green and Growing MPTP Progress Possible Through Industry Collaboration • Amcor Flexibles • NAMSA • ATMI LifeSciences • Nelson Laboratories • Barger, a division of Placon • Nordion • Beacon Converters, Inc. • Oliver-Tolas® Healthcare Packaging • Bischof + Klein GmbH & Co. • PeelMaster Packaging Corporation • E-BEAM Services, Inc. • Perfecseal, Inc. • Encaplast srl • Printpack Inc., Medical Packaging • Faxcim Corporation Division • Ferric, Inc. • Rollprint Packaging Products, Inc. • Mangar Medical Packaging • Sealed Air Nelipak • MEDIPACK AG • SteriPack Asia Sdn. Bhd
    [Show full text]
  • Packaging Testing Laboratory Rutgers Packaging Engineering Program
    Packaging Testing Laboratory Rutgers Packaging Engineering Program Rutgers The first and only university to offer packaging engineering with- in the School of Engineering, Founded in 1965, Rutgers holds title as the sec- ond oldest packaging program nationally. Students from Packaging Engineering Program have a strong background in mathematics, chemistry, physics, and computers and interdisciplinary skill in materials, chemical, industrial, and mechanical engineering. Packaging Laboratory As an integral part of the Rutgers Packaging Engineering Program for more than 20 years, our testing laboratory is ap- proximately 3000 square feet of laboratory space and is decocted to package testing in the Center for Packaging Engineering and the School of Engineer- ing A-building. Over the years through procurement and donation, a great variety of general and specialized equipment has been accumulated to measure package di- The Package mensions, functionality and product compatibility. Much equipment is devot- Testing ed to measuring conformance to industry or regulatory dictated perfor- mance including UPS, National Institute of Standards and Technology (NIST) Laboratory is and American Society of Testing and Materials (ASTM) standards. Tradition- ally, University laboratories are devoted to supporting the instructional pro- uniquely suited to gram and serve as a resource for research at the undergraduate, graduate and faculty level. The Package Testing Laboratory is uniquely suited to sup- support the port the academic program, university research projects and in addition pro- academic program, vide a service for fee to local industry. university research Testing Program In line with the University’s strategy to form partner- ships with local businesses, a Package Testing Commercial Service Program projects and has been initiated to allow clients to sponsor packaging research projects in addition and request fee based package testing procedures be conducted on their products.
    [Show full text]
  • Variables Affecting Film Permeability Requirements for Modified-Atmosphere Storage of Apples
    11111 2.8 2 5 :; 1111/2.8 11111 2.5 l.:.i 11111 . 1.0 .~ = I.iA I~ ~"I~ 2.2 ~.OOI~ I ~ ... I~ ... I~ I:.l I.l.: ~ I~ L:: I~ .0 '"L:. u I ....'"' ~~u t.:~"'" --1.1 --1.1 -- -- --. -- ii 4 11111 L25 111111. 111111.6 111111.25111111.4111111_6 MICROCOPY RESOLUTION TEST CHART MICROCOPY RESOLUTION TEST CHART NATIONAL BUREAU OF STANDARDS-1963·A NATIONAL BUREAU OF STANDARDS-1963-A Variables Affecting Film Permeability Requirements for Modified-Atmosphere Storage of Apples Technical Bulletin No. 1422 Agricultural Research Service U.S. DEPARTMENT OF AGRICULTURE Washington, D.C. ~ued May 1971 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402 • Price 60 cents CONTENTS SUInInary _________________________________________________________Page 1 Introduction ______________________________________________________ 1 General Inaterials and Inethods __ __ __ __ ___ ___ ___ _ __ __ ___ _ _ _ __ _ __ _ 2 Liners ________________________________________________________ 2 Tp.st fruits _____________________________________________________ 2 Modified atInOllpheres in liners _____ __ ___ __ __ ___ __ ___ ___ _ _ __ _ _ __ __ __ .(. Alnnospheres produced ____________ .----__________________________ 4 Pro~osed definition of liner atInosphere _____ .. ______________ .. ___ . _ _ 6 Effects of boxes on perIneability of liners _ _ _ __ _ ________ _ __ _ _ __ ____ _ 7 Ethylene in liner atInospheres _________________ .__________________ 8 VoluIne shrinkage in liners ____________________________________ • __ 9 General condition of apples stored in test liners _ _ __ _ _ __ _ __ __ _ _ _ _ 9 Storage conditions ________________________________________________ 13 Tenlperature in storage roo.ns ___________________________ .
    [Show full text]
  • Damping Package Design Using Structural Corrugated Board
    RESEARCH ARTICLE Damping Package Design Using Structural Corrugated Board PREFACE API 2015 Qi Zhang Katsuhiko Saito Kobe University Kobe University [email protected] [email protected] Katsushige Nagaoka TSK Coporation [email protected] ABSTRACT Packaging is designed to protect products from shock and vibration during transport. In recent years, paper cushioning materials, such as corrugated board and pulp molded packaging, are being increasingly used because they are environmentally friendly and easy to recycle. However, because no efficient packaging-design method yet exists for paper cushioning material, packaging engineers must rely on previous experience and the so-called trial-and-error method to design packaging. One reason for this situation is that, for most cases, the paper cushioning material used for protective packaging has a complicated structure and deforms after being subjected to repetitive shock and vibration. To address this shortcoming, we propose a damping design method for corrugated-board packaging that includes shock-absorbing and vibration damping elements. To verify that the resultant packaging functions as intended, we test three types of packaging in the following way: First, we use an existing design method to create cushioned packages and examine them via free-fall drop tests. Next, to test the robustness of packaging against vibration (i.e., for packaging destined for various modes of transport), we study the three packaging types by subjecting them to (i) vibration-only tests and (ii) drop-plus-vibration tests. For vibration-only tests, the packaging with highest static stress gives the best result, its “vibration fatigue” accounts for approximately 52% of the worst result given by packaging with the lowest static stress.
    [Show full text]
  • Guidelines on Stability Testing of Cosmetics
    COSMETICS EUROPE: GUIDELINES ON STABILITY TESTING OF COSMETIC PRODUCTS ALL RIGHTS RESERVED TO CTFA AND COSMETICS EUROPE MARCH 2004 03/094 - MC GUIDELINES ON STABILITY TESTING OF COSMETIC PRODUCTS March 2004 I. GENERAL CONSIDERATIONS 1. INTRODUCTION General The purpose of stability testing cosmetic products is to ensure that a new or modified product meets the intended physical, chemical and microbiological quality standards as well as functionality and aesthetics when stored under appropriate conditions. Because the development cycle of cosmetic products is relatively short, and also, in order that the testing activity does not become economically disproportionate in view of the multitude of product launches each year, each manufacturer must have at their disposal tests that are adapted to their activity. Each manufacturer should design their stability testing program such that it is reasonable and efficiently addresses the testing required. This document aims to set out guidelines in order to predict and assure the stability of products in the market place. Its purpose is to aid manufacturers of cosmetic products in the selection and the refinement of the appropriate stability tests. Although this guideline can provide a helpful starting point, it is important that manufacturers carefully evaluate new products and technologies and, where appropriate, adapt their testing to reflect differences between product types and formulations. However, all methods assuring the final stability of a cosmetic product against the categories cited in paragraph below, if it is at least equivalent to the recommendations of the following chapters, are considered as valid. Procedures must be put in place and documented within the manufacturer’s internal system.
    [Show full text]
  • Permeation and Its Impact on Packaging
    Room Environment Barrier or Package Product Wall FIGURE 1. Permeation diagram. Permeation and its impact on Packaging Permeation: The migration of a gas or vapor through a packaging material (FIGURE 1.) Michelle Stevens MOCON, Inc. Minneapolis, MN USA IMPACT OF PERMEATION: Shelf life is the length of time that foods, beverages, cases can be avoided with a proper testing protocol. pharmaceutical drugs, chemicals, and many other Under-packaging (inadequate barriers, improper gauges, perishable items are given before they are considered wrong material choices, etc.) allows the transmission unsuitable for sale, use, or consumption. Permeation of some compound(s) at a rate that causes product greatly influences the shelf life of these products as the degradation faster than the desired shelf-life. Repercussions loss or gain of oxygen, water vapor, carbon dioxide and from under-packaging can range from product complaints odors and aromas can rob the product of flavor, color, and returns all the way potentially to voided warranties, law texture, taste, and nutrition. Oxygen, for example, causes suits and legal action. adverse reactions in many foods such as potato chips. By measuring the rate at which O2 permeates through the Over-packaging probably will not result in legal action but package material, one can begin to determine the shelf-life can be a significant waste of money and material resources. or amount of time the unopened package will still provide Often times, a lack of product knowledge will lead a ‘good’ chips. manufacturer to use the best package available within a given budget in order to prevent under-packaging.
    [Show full text]
  • Food Laboratory Services Guide
    Food Laboratory Services Guide FDA Import Detention Services Food Adulteration, GMO & Quality Control Food Allergens Food Chemistry Food Microbiology Natural Toxins Nutritional Analysis Packaging Analysis Shelf Life Studies Specialty Chemistry Analysis Vitamins & Minerals The EMSL Diamond Standard EMSL Analytical, Inc., (EMSL) is a national network of laboratories located in key cities and regions nationwide and Canada. Established in 1981, the company has expanded its analytical services and ca- pabilities and now operates more than thirty-one locations all striving for excellence in providing quality laboratory services in a timely and cost competitive manner. Our diverse staff of over 585 employees includes a wide range of expertise, educational background and capabilities. These dedicated and capable employees follow the lead and standard of care demon- strated by the owner and founder of the company, Dr. Peter Frasca, who, as a hands on owner maintains daily involvement in our laboratory operations, and dictates that our work is consistent with his EMSL Diamond Standard. This “Diamond Standard” includes the following: u Quality Data - Strict Adherence to our Quality programs and regulatory requirements which comply with the ISO 17025 guidelines so that our data is tracked, managed, reported, and verified to be accurate and reliable. u Customer Dedication - We strive to create lasting, mutually beneficial relationships with all clients. We solicit feedback from our clients and we are committed to responding quickly to any questions or concerns that may arise before, during, or after an assignment. u Analytical Expertise - We employ highly qualified and experienced chemists, geologists, physicists, mycologists, microbiologists, biologists, materials scientists and industrial hygienists to enhance our analytical abilities and expertise.
    [Show full text]
  • 49 CFR Ch. I (10–1–14 Edition) § 172.102
    § 172.102 49 CFR Ch. I (10–1–14 Edition) LIST OF MARINE POLLUTANTS—Continued LIST OF MARINE POLLUTANTS—Continued S.M.P. Marine pollutant S.M.P. Marine pollutant (1) (2) (1) (2) Silver cyanide PP White phosphorus, wet Silver orthoarsenite White spirit, low (15-20%) aromatic PP Sodium copper cyanide, solid PP Yellow phosphorus, dry PP Sodium copper cyanide solution PP Yellow phosphorus, wet PP Sodium cuprocyanide, solid PP Sodium cuprocyanide, solution Zinc bromide Sodium cyanide, solid Zinc cyanide Sodium cyanide, solution Sodium dinitro-o-cresolate, dry or wetted with less than 15 per cent water, by mass [Amdt. 172–173, 55 FR 52474, Dec. 21, 1990] Sodium dinitro-ortho-cresolate, wetted with not less than 15 per cent water, by mass EDITORIAL NOTE: For FEDERAL REGISTER ci- PP Sodium pentachlorophenate tations affecting § 172.101, see the List of CFR Strychnine or Strychnine salts Sections Affected, which appears in the Sulfotep Finding Aids section of the printed volume PP Sulprophos and at www.fdsys.gov. Tallow nitrile Temephos TEPP § 172.102 Special provisions. PP Terbufos Tetrabromoethane (a) General. When column 7 of the Tetrabromomethane § 172.101 table refers to a special provi- 1,1,2,2-Tetrachloroethane sion for a hazardous material, the Tetrachloroethylene Tetrachloromethane meaning and requirements of that pro- Tetraethyl dithiopyrophosphate vision are as set forth in this section. PP Tetraethyl lead, liquid When a special provision specifies Tetramethrin Tetramethyllead packaging or packaging require- Thallium chlorate ments— Thallium compounds, n.o.s. Thallium compounds (pesticides) (1) The special provision is in addi- Thallium nitrate tion to the standard requirements for Thallium sulfate all packagings prescribed in § 173.24 of Thallous chlorate Thiocarbonyl tetrachloride this subchapter and any other applica- Triaryl phosphates, isopropylated ble packaging requirements in subparts PP Triaryl phosphates, n.o.s.
    [Show full text]
  • Premium Ventilation Package Testing
    Premium Ventilation Package Testing Pre-Installation Report – Task 5 Final Submittal August 29, 2008 Prepared by: Reid Hart, PE Delivered via electronic copy to BPA and partners. Contract No. 00038702 RTU AirCarePlus & Premium Ventilation Program COTR - Jack Callahan (503) 230-4496 / [email protected] COR - Rachel Kulak (503) 230-5091 / [email protected] PORTLAND ENERGY CONSERVATION, INC Table of Contents PROJECT OVERVIEW..................................................................................................................................... 3 COST EFFECTIVENESS ........................................................................................................................................ 3 TESTING PROJECT SCOPE & SCHEDULE ............................................................................................................. 4 Project Graphic Schedule............................................................................................................................. 5 RECRUITMENT GUIDANCE .......................................................................................................................... 6 TELE-CONFERENCE: AUGUST 12, 2007..................................................................................................... 7 MONITORING PLAN........................................................................................................................................ 8 PURPOSE OF MONITORING ................................................................................................................................
    [Show full text]
  • Variability in Compression Strength and Deflection of Corrugated Containers As a Function of Positioning, Operators, and Climatic Conditions
    CORE Metadata, citation and similar papers at core.ac.uk Provided by DigitalCommons@CalPoly Variability in Compression Strength and Deflection of Corrugated Containers as a Function of Positioning, Operators, and Climatic Conditions 2 J. SINGHl .*, P. BAINBRIDGE , S. P. SINGH3 and E. OLSEN4 lAssociate Professor, Industrial Technology, Cal Poly State University, San Luis Obispo, CA. 2Research Assistant, Industrial Technology, Cal Poly State University, San Luis Obispo, CA. 3Professor, School ofPackaging, Michigan State University, East Lansing, MI 4Assistant Professor, Industrial Technology, Cal Poly State University, San Luis Obispo, CA. ABSTRACT: ASTM D642 is a commonly used standard for measuring the ability of containers to resist external compressive loads applied to its faces, to diagonally opposite edges, or to corners. The procedure recommends testing by centering the specimen on the lower platen of the testing machine in the desired orientation, so as not to incur ec­ centric loading. It is also recommended by the standard that the load be applied with a continuous motion of the movable platen of the test­ ing machine at a speed of 0.5 ± 0,1 in. (12.7 ± .25 cm)/min until failure or a specified load, has been reached. It is recommended that the tests be conducted at "standard environmental" conditions of 23°C and 50% relative humidity. However, the vast majority of compression testers are not placed in rooms where humidity is controlled and multi­ ple operators may perform the tests thereby increasing the possibility of variation of reported data. No recent studies involving the effect of variation in the container location or the test speed on the compres­ sion strength values, however, are available.
    [Show full text]
  • Sterilization and Post-‐Sterilization Industry Summary Report
    DuPont™ Pre-Sterilization and Tyvek® Post-Sterilization Medical Industry Summary Packaging Report (Corrected) Transition November 2014 Project (April 2015) Bruce A. Yost, PhD Global MPTP Technical Director Michael H. Scholla, PhD Global MP Regulatory Director Jennifer H. Van Mullekom, PhD Senior Consulting Statistician Report Contents • Executive Summary • Medical Packaging Transition Project (“MPTP”) Overview • Testing and Results Overview o Seal Strength (ASTM F88) o Microbial Barrier (ASTM F2638) o Package Integrity Testing (ASTM F1929) o Visual Inspection (ASTM F1886M) • Conclusions • Appendix A: Category Results o Coated 1073B Pouches/Bags o Coated 1073B Form-Fill-Seal o Coated 1073B Lids/Rigid Trays o Uncoated 1073B Pouches/Bags o Coated 1059B Form-Fill-Seal o Uncoated 1059B Pouches/Bags o Uncoated 1059B Form-Fill-Seal EXECUTIVE SUMMARY Pre-sterilization and Post-sterilization package testing results for the 78 cells in the Medical Packaging Transition Project (“MPTP”) by third-party Nelson Laboratories indicate Functional Equivalence between current Tyvek® styles 1073B and 1059B and Transition Protocol material styles 1073B and 1059B. Specific test data to support this conclusion includes: • Seal Strength (ASTM F88): 479 out of 480 instances of Functional Equivalence • Microbial Barrier (ASTM F2638): 156 out of 156 instances of Non-Inferiority • Package Integrity (ASTM F1929): 8,424 out of 8,424 instances of No Dye Penetration • Visual Inspection (ASTM F1886M): 114,726 out of 114,729 instances of No Material Defects Additional details are provided in the Tables and Figures that follow, including those in AppendiX A, where results are presented by category. MEDICAL PACKAGING TRANSITION PROJECT (“MPTP”) OVERVIEW MPTP is a plan to transition production of DuPont™ Tyvek® styles 1073B and 1059B to the latest flash-spinning technology and equipment.
    [Show full text]
  • Veripac 400 Series NOV.2013 Edit Low
    Package Integrity Testing Inspection Systems a PTI technology Evaluate and analyze package integrity with precision and repeatability VeriPac systems can be easily integrated into the packaging process to improve quality, reduce waste, and provide operators with a clear understanding of package quality. VeriPac test systems are non-destructive, non-subjective and require no sample preparation. Test fixtures are designed to inspect flexible, rigid and semi-rigid packaging. Tests can be performed in any sequence and even repeatedly on a single sample. VeriPac’s inspection method is more reliable, cost effective and efficient than destructive methods, plus it eliminates subjective, misleading results that vary from operator to operator. VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method F2338 recognized by the FDA as a consensus standard for package integrity testing. This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines. Applications for VeriPac technology include stability studies, clinical trials, quality assurance testing and production statistical process control (SPC). VeriPac testers feature a patented single or dual vacuum transducer technology, PERMA-Vac, that has increased test sensitivity resulting in very consistent, reliable results. The VeriPac 400 Series also features a secondary Altitude Test Mode in accordance with ASTM Test Method D6653-13. Switching from vacuum decay mode to altitude mode in less than one minute,
    [Show full text]