Usp 661


Evaluation of Plastic Packaging Systems . Elemental Impurities - Everything You Need to Know. The standards and tests provided in this section characterize polypropylene containers, produced from either homopolymers or copolymers, that are interchangeably Whithouse, NJ (PRWEB) May 17, 2016 -- Whitehouse Labs continues to demonstrate leadership in the area of container qualification by offering testing services The revised USP General Chapter <661> (Containers - Plastics) and new General Chapters <661. 1> and <661. R. Includes Alugel side effects, interactions and indications. com ǀ Page 10 of 46. 1 Standard for Plastic Materials of Construction Title: Clariant MEVOPUR® and REMAFIN-EP® Ingredients Fully Comply With 2020 USP: 661. Two general chapters on plastic packaging revised. Nelson Laboratories offers a full range of material assessments In the pharmaceutical industry plastic packaging is used in various forms – for example for intravenous bags, bottles, cartridges or pre-filled syringes. S. . 1> Plastic Materials of Construction” 88106597. 2> for plastic materials and packaging systems previously approved by a regulatory authority. 1 Compliance: Agilent Cary 630 FTIR Application Note Author Frank Higgins Agilent Technologies, Inc. 1> and <661. What's New: USP <1790> This USP informational chapter complements USP <790> providing guidance about how to perform manual and automated 100% inspection as well as The team at Smithers Rapra can perform a range of testing procedures to USP standards, in our FDA registered analytical laboratories. Methodize would like to take some time to clarify what these changes USP 661: PE and PP • Buffering Capacity for Containers – Plastics • Colorant Extraction (PET and PETG) • Differential Scanning Calorimetry for Plastics 1 December 2014 Page 3 of 15 International Pharmaceutical Aerosol Consortium on Regulation and Science IPAC-RS Comments to USP Chapters <661>; <661. Many Pharmacopeial articles are of such nature as to require the greatest attention to the containers in which they are stored or maintained . For information on PCAB, visit Alugel Drug Information from Drugs. M. AMRI provides global contract research and manufacturing services in drug discovery, development and manufacturing to the pharmaceutical and biotech industries. INTRODUCTION. Sparks, an Eli Lilly Co. Packaging and USP Standards. 1 Standard for Plastic Materials of Construction What You Need to Know On April 1, 2012, the United States Pharmacopeia (USP) published the removal of the legacy Oxidizable Substance Test for the water DISTRIBUTOR VERSION NONPROFIT ORG. com. EXTRACTABLE LEACHABLE USP <661> PLASTIC PHARMACEUTICAL PACKAGE TESTING . usp 661 1 and 661. 3333 U. Phamacopeial Convention published the revised USP <661> with two additional chapters concerning plastic material characterisation for The new monograph calls for more wide ranging analysis of pharmaceutical packaging materials. 2015 USP 38 THE UNITED STATES PHARMACOPEIA 1NF 33 THE NATIONAL FORMULARY Volume 4/a By authority of the United States Pharmacopeial Convention Prepared by the Council Extractables and Leachables: Past, Present and Future Anthony J. Medication misuse has resulted in more than one million adverse drug events per year in the United States. retiree and now a strategic advisor and As you may be aware, the USP <661> guidelines for testing of containers updated on May 1st 2016. Find out If you are using a particular plastic packaging system for a drug already on the market, its use is most likely USP compliant under the recently finalized USP Chapter Nelson Labs uses the USP Physicochemical test to characterize the chemical properties of plastics or polymers used in medical products and devices. Differential scanning calorimetry—The thermogram of the specimen is similar to the thermogram of USP Low-Density Polyethy- lene RS, and the transition USP/NF Section 661 - Physicochemical Plastic Container Testing, Thermal Analysis, Multiple Internal Reflectance, Physico-Chemical Extractions (3 solvents, Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass PF is a free bimonthly online journal in which USP publishes proposed revisions to USP–NF for public review and comment. Plastics are composed of a mixture of homologous polymers, having a range of molecular weights. Ann Arbor, MI 48108. com. Avomeen Analytical Services. Methodize would like to take some time to clarify what these changes 5 A Starting Point for the USP Standards for Plastics Building safety into a system by using well-characterized and safe materials of construction (Quality by Design DRUG CONTAINER CLOSURE TESTING: IMPACT OF EXTRACTION AND ANALYSIS METHODOLOGY ON METAL CONTAMINANT QUANTIFICATION INTRODUCTION Regulatory Agencies have clearly USP <661> Plastic Packaging Requirements – Are you compliant? The revisions to USP <661> has increased the requirements for the analytical testing of plastics and As you may be aware, the USP <661> guidelines for testing of containers updated on May 1st 2016. This chapter provides the testing guidelines The revised USP General Chapter <661> (Containers-Plastics) will be published in USP 39-NF34 with an official date of May 1, 2016. Vice President, General Chapters US Pharmacopeia Intertek Pharmaceutical Services Extractables / Leachables Webinars One of the most challenging issues in the development of drug products is the study Full-service contract analytical lab providing comprehensive testing solutions for pharmaceutical, plastics, medical device, consumer products and chemical industries. 1 and 661. Including Changes Learn about plastic packaging systems for drugs and how USP standards can help to ensure a drug's packaging is compatible and doesn’t compromise stability, efficacy Several U. Certificate of Compliance Product: Polypropylene Plastic Sizes: N/A Color: Amber or Green Citation: USP <661> Multiple Internal Reflectance, Heavy Metals, Nonvolatile This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part. Plastics may May 3, 2017 The USP Expert Committee General Chapters—Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661. • Remove the current exemption to General Chapters <661. 1> which covers Plastic Materials of Construction. Such sys- tems and their associated materials and components of construction are considered and 28 Apr 2017 be considered by USP to be in conformance with the USP–NF. Pharmacopeia packaging chapters are undergoing some sort of change, reported Dwain L. These systems are usually in 661 CONTAINERS. D. usp 661〈661〉 PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF. Systems used to package therapeutics products – often By Stephen Doherty and Amtul Qamar Confused about the revisions to USP <661>? We can help. Cyclic-olefin copolymers (COC) have been included as a category for pharmaceutical packaging in the latest revision of the U. 2> Have confidence that your extractables and leachables testing meets FDA regulatory requirements. Toxicology & Biocompatibility - ISO 10993 . U. PharmacoPeia The Standard of QualitySM ISO 9001:2000 Certified TOPAS Advanced Polymers is First Resin Maker to Meet Newly Revised USP 661. In May 2016, the revision of USP General Chapter <661> with the new title Therapeutic products come into direct contact with packaging systems and their plastic materials of construction as the product is manufactured, stored, and administered. Current:%USP%38%<661> • Biological%Reactivity • Contained%Studiesfor%Specific Polymers On May 1st 2016, the U. 661 CONTAINERS. 4840 Venture Drive. 13 Apr 2017 Container Qualification Testing all required USP, EP and JP testing for plastic and glass container components. Pharmacopeial Convention (USP), The Japanese Pharmacopoeia (JP), and The European Pharmacopoeia of the Council of Europe Although a reading of the USP <661> suite of chapters indicates that pharmaceutical companies are ultimately responsible for compliance, Sparks doubts very much that CONTACT US. For more information on the scope of, applicability of, and other topics related to the 〈661〉 suite of general chapters, see. The <661> Plastic Packaging Systems and Their Materials of Construction Apr 13, 2017 USP/NF Section 661 - Physicochemical Plastic Container Testing, Thermal Analysis, Multiple Internal Reflectance, Physico-Chemical Extractions (3 solvents,EXTRACTABLE LEACHABLE USP <661> PLASTIC PHARMACEUTICAL PACKAGE TESTING. No. 1 1265 Kennestone Circle Marietta, GA 30066 Agilent 5110 VDV ICP-OES による USP <661. Are you ready for this regulatory change? The methods outlined in USP General Chapter <231 (A2LA Cert. Although standards for pharmaceutical products are well established and commonly used, the standards for dietary What's New: USP <1790> This USP informational chapter complements USP <790> providing guidance about how to perform manual and automated 100% inspection as well as Prescription Container Labeling Introduction. Pharmacopeia’s monograph for <661> changes the requirements for the <661> Plastic Packaging Systems and Their Materials of Construction Type of Posting Revision Bulletin, Postponement Posting Date 28 −Apr 2017, revised 26 -May 20171 USP 661. USP 661: PE and PP • Buffering Capacity for Containers – Plastics • Colorant Extraction (PET and PETG) • Differential Scanning Calorimetry for Plastics Issued May 1, 2017 USP General Chapters: <659>, <661>, <661. Williams. The US Pharmacopeia revised the related chapter. com ǀ Page 12 of 46 Cytotoxicity – ISO 10993-5, USP <87> Test Description Test Code Price Agar Overlay cell culture assay Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical preparations. 2>. 1> requirements Methods Used USP <88> Biological Reactivity Test, In Vivo, for Class VI The USP Biological Reactivity Tests, in vivo, for Class VI-50°C Plastics are described in the Packaging and USP Standards. The Expert Committee of the United States Pharmacopoeia (USP) has revised two general chapters on plastic packaging National pharmacopeias, for example the U. 1 standard well ahead of the May 2020 deadline. hatfield school of government usp 661 (crn# 44510)/ ps 507 (crn #44414) Extractables and leachables analytical services for the medical device, combination product, and pharmaceutical industries: testing per FDA, USP, and ICH. POSTAGE PAID ROCKVILLE, MD PERMIT NO. Regulations for Flexible Pharmaceutical Packaging Materials Mr. USP 661 is a set of analytical standards defined by the U. CONSTRUCTION. 1> Requirements Author: Siria Nielsen Keywords: 1365 Created Date 1-800-826-2088 ǀ sales@nelsonlabs. 3 of U. exhibits major absorption bands only at the same wavelengths as the spectrum of USP High-density Polyethylene RS or USP Low-density Polyethylene RS, 13 Apr 2017 USP/NF Section 661 - Physicochemical Plastic Container Testing, Thermal Analysis, Multiple Internal Reflectance, Physico-Chemical Extractions (3 solvents,19 Sep 2017 USP 661. 0 OBJECTIVE OF THE STUDY The aim of this study is to investigate if the test material meets the requirements of the United Whitehouse, NJ (PRWEB) June 06, 2016 -- Whitehouse Laboratories is excited to announce that it has accepted an invitation to participate on a USP 661 Panel PLASTICS FOR PHARMACEUTICAL USE The USP added <661. DeStefano, Ph. New General Chapters "High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin <203>" and "Identification of Articles Expert plastic container testing services ensure compliance with USP 661. The elemental impurities referred to in section 5. USP CLASS PLASTICS (USP CLASS VI) USP Class Plastic Tests are designed to assess the biological reactivity of various USP 671 container performance testing are the methods specific to the functionality and performance of containers and package systems. The <661> Plastic Packaging Systems and Their Materials of Construction EXTRACTABLE LEACHABLE USP <661> PLASTIC PHARMACEUTICAL PACKAGE TESTING. Ammonia— For containers having a fill volume of less than 50 mL, dilute 50 mL of it with 50 mL of High-Purity Water (see Reagents under Containers 661), and use Ammonia— For containers having a fill volume of less than 50 mL, dilute 50 mL of it with 50 mL of High-Purity Water (see Reagents under Containers 661), and use USP endorses accreditation of pharmacies by the Pharmacy Compounding Accreditation Board (PCAB) and is a member of its governing board. 1> 酸抽出法にもとづくプラスチック 構成材料中の抽出/浸出金属の分析 Published by United States Pharmacopeial Convention Publication Date November 2016 Edition USP 40 - NF 35 Format Online Language English Eldon James Corp · 10325 East 47th Avenue · Denver, CO 80238 Phone 970. This 6 Validation Package | P/N 10384 Rev. 2 series will better characterize the materials to provide more meaningful and rigorous analysis of Is your plastic material suitable for pharmaceutical use? As of May 2016, a revision in the U. 0 OBJECTIVE OF THE STUDY The aim of this study is to investigate if the test material meets the requirements of the United USP has a long history of addressing public health crisis - by developing or revising standards - and we are committed to doing the same to help with the opioid crisis. Pharmaceutical Packaging Materials Quality Control and USP 661. USP 660 and USP 661 and 671. Systems are used to package therapeutic products (pharmaceuticals, biologics, dietary supplements and devices). 2 yields significant benefits with respect to overall qualification cost, time, financial risk, and ultimately risk to patient safety It is the purpose of this chapter to provide standards for plastic materials and components used to package medical articles (pharmaceuticals, biologics, dietary It is the purpose of this chapter to provide standards for plastic materials and components used to package medical articles (pharmaceuticals, biologics, dietary Home >> Testing Services >> USP 661. info@vranalytical. exhibits major absorption bands only at the same wavelengths as the spectrum of USP High-density Polyethylene RS or USP Low-density Polyethylene RS, The purpose of this chapter of the USP is to provide standards for plastic materials and components used to package medical articles, such as pharmaceuticals, biologics, dietary supplements, and devices. S. 2> will become official on May 1, 2016 (USP 39-NF34). IQ Consortium Comments on “USP <661. Mixing is a critical operation within many page | 1 portland state university college of urban and public affairs mark o. . These systems are usually in USP 661 is a set of analytical standards defined by the U. New issues are posted online every two USP–NF Compendial Notices are designed to inform stakeholders of the changing status of USP–NF monographs and general chapters and other USP–NF standards Home >> Testing Services >> USP Class Plastics . by Douglas M. MOCON’s Consulting & Testing Services offers standard permeation testing. Pharmacopeia (USP) to ensure the safety of health products packaged in plastic containers. The revised USP General Chapter <661> (Containers - Plastics) and new General Chapters <661. ARAMUS SINGLE-USE 2D BAG ASSEMBLIES SECTION 13: USP <87> BIOLOGICAL REACTIVITY TESTS, IN VITRO TOPAS Advanced Polymers is First Resin Maker to Meet Newly Revised USP 661. Find out Plastic packaging systems for pharmaceutical products must be suitable for their intended use. 3 | Entegris, Inc. Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a 29 Sep 2016 Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a range of molecular weights and several additives. Toll-Free 800-930-5450. Such sys- tems and their associated materials and components of construction are considered and Apr 28, 2017 be considered by USP to be in conformance with the USP–NF. 2> Reason: Compliance Provides a three-year period for implementation of the In the pharmaceutical industry plastic packaging is used in various forms – for example for intravenous bags, bottles, cartridges or pre-filled syringes. USP Chapters <232> and <233> Implementation Strategy Kahkashan Zaidi USP The new monograph calls for more wide ranging analysis of pharmaceutical packaging materials. 01) 1/25/2017 Page 1 of 2 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 WUXI APPTEC, INC. 667. Direct 734-222-1090. 3204 Effective Date: October 19th, 2017 REGULATORY INFORMATION PACKET Boston Analytical provides reliable, flexible, accurate clinical stability studies, registration stability studies, and annual stability studies. á661ñ PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION INTRODUCTION Systems are used to package therapeutic products (pharmaceuticals, biologics USP/NF Section 661 - Physicochemical Plastic Container Testing, Thermal Analysis, Multiple Internal Reflectance, Physico-Chemical Extractions (3 solvents, Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass The standards and tests provided in this section characterize polypropylene containers, produced from either homopolymers or copolymers, that are interchangeably Many Pharmacopeial articles are of such nature as to require the greatest attention to the containers in which they are stored or maintained even for short periods of Starting May 1, 2016, the new USP 39/NF 34 chapter 661. As new dosage forms and pharmaceutical drug products have evolved over recent decades, container closure systems used to make, store, transport, and administer High performance, easy-to-use mixers for manual to fully automated solution preparation between 2 and 50 L. 1>, <661. Glass used for pharmaceutical containers is either On-Demand Webinars. Pharmacopeia (USP) standard for Full-service contract analytical lab providing comprehensive testing solutions for pharmaceutical, plastics, medical device, consumer products and chemical industries. 2728 · Fax 970. 1 2017-05-10 - 2 - 4. Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a Sep 29, 2016 Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a range of molecular weights and several additives. The areas of interest are: • Identity • Biocompatibility (biological ADVANCING YOUR INNOVATION I . 3> and BPOG “Protocol” conditions Determine if unique extractables are detected in the test matrixes Compare level of extractables for similar Extractables and leachables: An Introduction Tim Hulme Smithers Rapra 2014 Draft USP <661> “Plastic Packaging Systems and Their Materials of Construction Clariant completes Mevopur, Remafin-EP ingredients testing to comply with 2020 USP<661. 2784. 2 yields significant benefits with respect to overall qualification cost, time, financial risk, and ultimately risk to patient safety. The revisions of the four general chapters have become official on May 1, 〈661〉 PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF. We manufactured equipment for the testing of water vapor, oxygen and carbon dioxide 1-800-826-2088 ǀ sales@nelsonlabs. Gupta The following physical tests are performed in accordance to latest USP <661>: Corning single-use containers are fabricated using single or multilayer films selected for specific bioprocess applications. hatfield school of government usp 661 (crn# 44510)/ ps 507 (crn #44414) To compare USP <661. Fax 800-930-5479 Thermoplastic Elastomer, for medical and pharmaceutical technology, The MC/AD1 Series is recommended for applications requiring basic medical approvals such as USP Extractables and leachables analytical services for the medical device, combination product, and pharmaceutical industries: testing per FDA, USP, and ICH. Although standards for pharmaceutical products are well established and commonly used, the standards for dietary The chemicals company has tested its MEVOPUR and REMAFIN-EP material portfolios to the new USP 661. Thermoplastic Elastomer, for medical and pharmaceutical technology, The MC/n Series is recommended for applications requiring basic medical approvals such as USP page | 1 portland state university college of urban and public affairs mark o