Packaging & Package Marking Requirements
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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 -
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 -
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. -
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 ___________________________ . -
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. -
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. -
Economics of Food Labeling
Economics of Food Labeling. By Elise Golan, Fred Kuchler, and Lorraine Mitchell with contributions from Cathy Greene and Amber Jessup. Economic Research Service, U.S. Department of Agriculture. Agricultural Economic Report No. 793. Abstract Federal intervention in food labeling is often proposed with the aim of achieving a social goal such as improving human health and safety, mitigating environmental hazards, averting international trade disputes, or supporting domestic agricultural and food manufacturing industries. Economic theory suggests, however, that mandatory food-labeling requirements are best suited to alleviating problems of asymmetric information and are rarely effective in redressing environmental or other spillovers associated with food production and consumption. Theory also suggests that the appropriate role for government in labeling depends on the type of information involved and the level and distribution of the costs and benefits of providing that information. This report traces the economic theory behind food labeling and presents three case studies in which the government has intervened in labeling and two examples in which government intervention has been proposed. Keywords: labeling, information policy, Nutrition Labeling and Education Act, dolphin-safe tuna, national organic standards, country-of-origin labels, biotech food labeling Acknowledgments We wish to thank Lorna Aldrich, Pauline Ippolito, Clark Nardinelli, Donna Roberts, and Laurian Unnevehr for their comments on earlier drafts of this paper. We appreciate the guidance provided by Nicole Ballenger, Mary Bohman, Margriet Caswell, Steve Crutchfield, Carol Jones, Kitty Smith, and John Snyder. We thank Tom McDonald for providing his editorial expertise. Elise Golan and Fred Kuchler are economists in the Food and Rural Economics Division, ERS. -
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. -
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. -
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. -
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 ................................................................................................................................ -
Federal Labeling Requirements for Herbal Dietary Supplements
GUIDANCE: Federal Labeling Requirements for Herbal Dietary Supplements September 2019 (Revised) Prepared by the American Herbal Products Association This document was originally published in August 1999 under the title “Labeling of dietary supplements: Saying it right the first time.” It has been updated to reflect interim changes in law, including those from the May 2016 Final Rule revising FDA’s nutrition labeling regulations. This document is the property of the American Herbal Products Association (AHPA) and is for AHPA purposes only. Unless given prior approval from AHPA, it shall not be reproduced, circulated, or quoted, in whole or in part, outside of AHPA, its Committees, and its members. Cite as: American Herbal Products Association. September 2019. GUIDANCE: Federal Labeling Requirements for Herbal Dietary Supplements. AHPA: Silver Spring, MD. GUIDANCE: Federal Labeling Requirements for Herbal Dietary Supplements Disclaimer The information contained herein is not and should not be considered legal advice. This AHPA publication is not a substitute for the actual statutes, regulations, and agency guidance that apply to the products and activities that are discussed herein. The information contained herein is not intended to replace or supersede federal or any state statutes, regulations or guidance. This document is specifically relevant to federal labeling requirements for dietary supplement products. No other issues related to the manufacture, marketing, or sale of food, dietary ingredients, dietary supplements, cosmetics, or any other class of consumer goods are addressed herein. While AHPA believes the information herein is accurate, AHPA advises all individuals and entities using this information to discuss all aspects of their application of this information with an attorney or qualified consultant, or with personnel at relevant regulatory agencies.