regulatory considerations when resin sourcing

Design Considerations for Selection of Skin

Design Considerations for Selection of Skin-Contacting Adhesives The huge array of pressure-sensitive materials available can make product selection a daunting task This article outlines some of the most basic considerations that one should TongWei into account when choosing pressure-sensitive adhesive tapes for skin-contact applications

Aftermarket New ReCon Parts Packaging Standards

Any questions regarding these Packaging Standards can be sent to our Cummins Packaging FE Leaders Paul G Ouillette Sidney Joseph Global Packaging Engineering Manager New and Recon Parts- Global Packaging Leader Ph# 812-314-1948 Ph# 901-546-5348 Email: paul ouillettecummins Email : sidney o josephcummins Cummins Packaging

Addressing Hazardous Implications of Additive

Addressing Hazardous Implications of Additive Manufacturing: Complementing Life Cycle Assessment with a Framework for Evaluating Direct Human Health and Environmental Impacts Justin Bours University of California Berkeley CA USA Search for more papers by this author Brian Adzima Corresponding Author E-mail address: brian adzimaautodesk Autodesk San Francisco CA

Water quality for device reprocessing

Water quality for device reprocessing CBSPD Expiration: April 30 2021 IAHCSMM Expiration: April 4 2019 Richard Schule Apr 8th 2019 May 2016 The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of five (5) years from the date of original publication Successful completion of the lesson and post

6 Guidelines To Follow When Developing Combination Products

6 Guidelines To Follow When Developing Combination Products 2 While the development of a combination product comes with significant patient benefits through technology and molecule innovation that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market in addition to any post-marketing activities The area of combination

south korea marketting rubber additives zmbt the

PDF Regulatory considerations for exporters of food contact materials Regulatory considerations for exporters of food contact materials This expert focus prepared by Jeffrey A Keithline and Herb Estreicher of Keller and Heckman outlines South Korea's regulatory scheme for food contact materials and guides companies through the reglatory requirements for exporting FCM's to South Korea

6 questions to ask when designing polymer components

6 questions to ask when designing polymer components for medical devices September 24 2018 By Heather Thompson [Image courtesy of PolyOne Distribution] Choosing the right polymer for the job can be a daunting task Here are the right questions to ask before you begin the process Karen Heroldt PolyOne Distribution Choosing polymers is complicated in the high-sTongWeis world of medical and

Dual Sourcing and the Single

There are numerous challenges when considering true dual sourcing and many relate to the complexity of the single-use supply chain The SUS business is highly customized and there are thousands of single-use components many of which only work with other components made by the same supplier Of course not all those components need the same scrutiny depending on their criticality and demand

Fundamental Strategies for Viral Clearance

Through international collaborations regulatory guidelines stress a holistic approach that includes appropriate sourcing of materials demonstrating the capability of a manufacturing process for viral clearance and testing in process among others Critical use of an effective viral safety program involves careful selection and testing of cell lines and original raw materials for

When will going green go mainstream?

When will going green go mainstream? Rick Dana Barlow Aug 22nd 2017 Dan Constant View Image Gallery Healthcare organizations may point to a variety of reasons that motivate them to pursue sustainable products and services either as alternatives to current products and services under contract or in lieu of more traditional offerings Motivations range from environmental awareness


MATERIAL SAFETY DATA SHEET Polypropylene (PP) 1 SUBSTANCE/PREPARATION COMPANY/UNDERTAKING IDENTIFICATION Chemical Name Synonyms : Polypropylene (PP) Copolymer Trade Name : OPALENE-PP Chemical Family : Polyolefin C A S No : 9010-79-1 Manufacturer's Name : ONGC Petro additions Limited Address : Polymer Marketing Group: 1st Floor

Design and Deployment Strategy for Single

Single-use systems (SUS) promise many benefits to the biopharmaceutical industry including reduced cross-contamination risks lower capital investment elimination of cleaning and sterilization operations reduced turnaround times and the ability to scale an operation up or down with limited additional investment [1 2] SUS are provided in a sterile readyto- use format or as non-sterile


regulatory requirements (safe and legal for your intended use) and your specifications (contribute to the functionality and quality of your process and product) Historically research and development worked alone when selecting a new raw material But now a broad team of expertise is needed due to increased access to unique and complex materials global sourcing handling methods customer

Sustainable Packaging Solutions

Materials Sourcing Development Drive Holistic Procurement Strategies that Factor for Price Supply Chain Optimization and Performance Determining the right design and packaging materials – from biodegradable fibers to a specialized polymer resin – for a particular product or


SUPPLIER QUALIFICATION MANAGEMENT GUIDELINE December 2009 2 Content 1 Introduction 2 Chapter 1: Supplier Selection 3 Chapter 2: Due Diligence 4 Chapter 3: Quality Assessment 5 Chapter 4: Change Control + Production Assessment 6 Chapter 5: Supply Chain Security 7 Chapter 6: Ongoing Monitoring and Evaluation 8 Appendices Appendix 1: Examples of Critical/ non Critical Raw Materials


List B is not exhaustive and will be reviewed from time to time if and when there are any issues on sourcing for the comparator/innovator product III Other Considerations LIST C 1 Nystatin Bioequivalence study can be waived for a generic product containing nystatin due to local effect and no significant systemic absorption However in-vitro

Qualification of Excipients for Use in Pharmaceuticals

Regulatory authorities who regulate medicines Suppliers Regulatory Authorities Users IPEC This document offers best practice and guidance in the establishment of an effective relationship between an excipient supplier and excipient users The excipient supplier may be a manufacturer or a distributor (or both) It concentrates on the issues that the two parties are likely to encounter and

Smart Sourcing Solutions Projects

In addition the base resin price was lowered 12% and all future resin buys were tied to the agreed upon market index So when all the tools were moved and the project finished the OEM had two dependable molders over 30% in savings two 1 000 ton presses a tighter supply chain and lots of piece of mind

REACH and Safety Data Sheets

Disposal considerations 14 Transport information 15 Regulatory information 16 Other information Guidance on how to compile a SDS is detailed in Annex II of REACH A SDS should be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market (unless the relevant Competent Authority in the Member State(s) concerned has indicated otherwise

How to Follow a Smart Flexible Material Sourcing Path

How to Follow a Smart Flexible Material Sourcing Path June 14 2017 Sponsored Content Sponsored content Material sourcing is a challenging and time-consuming exercise This is especially true in the flexible materials segment as there are a number of new materials meeting rapidly growing Internet of Things (IoT) applications There are many aspects of flexible materials sourcing that are


The architecture of the resin star like structure allows us to tune the viscosity of the alkyd resin which offers the potential to avoid the usage of volatile organic compounds The number of lactic acid molecules (n) per mainly determined the viscosity and this can be controled by the proper ratio of lactic acid over pentaerythritol The first trials investigated the technique of alkyd resin

Composite Development Services

Composite development services supporting research specification design and production including performance and property testing of composite materials Our composites development services ensure that the performance of each unique composite formulation is optimised and achieves the certification required for its intended use across all composite applications such as sandwich materials

Successful Technology Transfer Process Validation and

Successful Technology Transfer Process Validation and Partnership with a CMO The authors present lessons learned from a case study of the transfer of a cell culture biotherapeutic process to a CMO Mar 02 2011 By Sushil Abraham Howard Bland BioPharm International Volume 2011 Supplement Issue 2 ABSTRACT The use of contract manufacturing organizations (CMOs) for

Application of ICH Q12 Tools and Enablers

Application of ICH Q12 Tools and Enablers Post-Approval Lifecycle Management Protocols 1 Outline • Introduction: evolution of PACMP concept • Expanded (multi-site multi -product) change management protocols (Roche presenter: Wassim Nashabeh) • Risk-based (step-2) Variation classification in case of changes for biological products in accordance with an approved Post Approval

(MSDS) Sangre de Drago Resin

LIQUID RESIN EXTRACT MSDS 1 PRODUCT NAME AND COMPANY IDENTIFICATION Product Name: Product Use: Company Name: Company Address: Date Issued: Emergency Telephone Number: SANGRE DE DRAGO LIQUID RESIN EXTRACT Personal Care Formulations Natural Sourcing 341 Christian Street Oxford CT 06478 USA 06/29/2018 Chemtrec Tel: (800) 262-8200 2

Regulation impact statement: Proposed regulatory scheme

This option addresses Dimension 1 - Misalignment of regulatory oversight with level of risk quite well in that regulatory oversight would be aligned with the risk of the medical device as it is for all 'mass produced' medical devices The existing classification rules effectively and efficiency class devices according to risk and existing conformity assessment requirements provide oversight

Recycled Content Use in Washington

barriers to sourcing or incorporating more post-consumer recycled plastic into their products Regulatory requirements – reprocessors must obtain FDA approval before marketing their PCR for use in food-contact packaging via a letter of no objection (LNO) The limited number of reprocessors with this designation means that the supply of food-grade PCR is even more constrained than PCR

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