White Paper: Microorganism and Biotechnology Regulation In Canada and The United States

Please fill out the form below to download our Microorganism and Biotechnology Regulation In Canada and The United States white paper.

White Paper: EU Food Contact Regulations - Highlights of (EU) 2023/1442 & (EU) 2023/1627

Learn more about the 16th and 17th amendments of Commission Regulation (EU) No 10/2011 for plastic food contact materials ((EU) 2023/1442 and (EU) 2023/1627).

White Paper: European Union Carbon Border Adjustment Mechanism (CBAM)

EU Regulation 2023/956 introduces the Carbon Border Adjustment Mechanism, mandating importers to report emissions of goods into the EU from Oct 1, 2023.

Unmasking Cyber Threats to Critical Infrastructure

Get insights into critical infrastructure vulnerabilities in the digital age. Explore energy, healthcare, and transportation sectors, and understand the growing threat of cyberattacks via the supply chain.

Download: Payne Cell Gravimetric Measurements in Polymer-solvent Systems for Diffusion Coefficients and Isotherm Data

This paper explores using Payne cells to measure diffusion and solubility coefficients in polymer/solvent systems, focusing on toluene-silicone rubber.

Download The Road to ‘Net Zero’ White Paper

In the urgent fight against climate change, the focus is on halting and not just reducing carbon emissions. With the Paris Agreement's 1.5°C target and 'net zero' goals, businesses and governments face mounting pressure to take action and be accountable for their carbon footprint.

White Paper: The Importance of Aligning a Pharmaceutical Audit Scope with the Correct Standard

Maintaining compliance and transparency in pharma supply chains is crucial. Quality audits of suppliers are vital to ensure high production standards. Choosing the right industry standard mitigates risk.

The Benefits of Lab-Scale Compounding

The polymer industry innovates for lightweight, durable materials with low VOC emissions. Compounding enhances properties, often via lab-scale extrusion for quicker testing and development, meeting diverse industry needs like aerospace, automotive, and medical devices.

Recent Amendments to Regulation (EU) No 10/2011

Commission Regulation (EU) No 10/2011 outlines requirements for plastic food contact materials (FCMs). This paper by Hilde Raemen emphasizes staying updated on amendments to ensure product compliance.

White Paper: Taking Control of Restricted Substances in your Products

Manufacturers must furnish requested information to enforcement agencies to demonstrate compliance with Restricted Substance Regulations. Failure risks sanctions, including blocked shipments and damage to brand reputation.

The Process Approach: Adding Business Value and Minimising Risks

Embrace the Process Approach as more than just compliance. It's a philosophy for efficient results. This whitepaper introduces tools like the Turtle Diagram and SWOT Analysis to support strategic objectives and foster an improvement mindset.

The ISO 45001:2018 Migration

Stay updated on OHSAS 18001 to ISO 45001 migration. Our whitepaper highlights key changes and explains the transition process for maintaining certified Occupational Health and Safety Management System Certification.

The European Food Contact Regulations

This whitepaper discusses recent changes in European food contact material regulations, focusing on amendments to Commission Regulation (EU) No 10/2011 for plastic FCMs. It covers key elements of the amendments and summarizes regulations for non-harmonized materials. Additionally, it outlines compliance steps and supply chain responsibilities.

White Paper Download: Understanding and Attaining Compliance to the EU Detergent Regulation

Cleaning products, predominantly detergents, are defined as substances containing surfactants for washing and cleaning. They come in various forms and serve household, institutional, or industrial purposes, catering to diverse cleaning needs and preferences.

Compatibility Testing and Life Estimation of Non-Metallic Materials White Paper

This paper examines the utilization of Non-Metallic Materials in oilfield applications, highlighting their desirable attributes and potential vulnerabilities. It emphasizes the importance of understanding material interactions with the environment to mitigate failure risks. Various testing approaches, including accelerated testing, are explored, supported by recent test program examples.

White Paper: Technologies to Measure Immunogenicity

This White Paper provides an introduction to Surface Plasmon Resonance (SPR) as a immunogenicity technology and a case study that compares both SPR and a bridging ECL format to detect anti-infliximab antibodies.

Epoxy Cure by Near Infrared Spectroscopy

In this white paper, you will gain insights into the epoxy cure process using near infrared spectroscopy. ​ The document explores the different chemical reactions involved in epoxy curing and how they impact the properties and performance of the cured resin. 

Polymer Rheology Testing Case Study: Supporting Formulation & Product Development

Polymer rheology testing aids in optimizing product formulations and process conditions. Case study highlights HA gel development benefits.

White Paper Download: Evaluation of Toothbrush Performance

In vitro methods enhance oral care product development, assessing toothbrush design for cleaning performance through the pellicle cleaning ratio test (PCR). Download the whitepaper to explore this testing approach's potential in comparing toothbrushes of varying designs.

White Paper: Requirements for Elemental Impurities Testing

This paper highlights the significance of testing for elemental impurities in the drug development process to ensure product safety. It discusses the importance of conducting risk assessments and adhering to applicable standards, particularly the USP <232> and USP <233> standards aligned with ICH guidelines.

Fitness-for-Service Evaluation of the Off-Gas Scrubber Chemical Plant

This project aimed to evaluate the fitness-for-service of the off-gas scrubber at the Choctaw Plant. Discover the findings from the Tolerable Flaw Analysis in our report.

White Paper: The EU Biocides Product Regulation 528/2012

In 2012, the EU Parliament adopted the Biocidal Products Regulation (BPR to enhance the evaluation and authorization process for biocidal products. This regulation harmonizes rules for biocide availability and use, establishing criteria for active substances, product authorization, mutual recognition, and simplified procedures. By replacing directives with directly transposable and binding regulations, the BPR ensures uniform risk controls across the EU.

Trace Analytical Methods and Techniques for Testing Extractables and Leachables

Explore trace level analysis in pharma: critical for E&L testing. This white paper navigates standards, challenges, solutions, and case studies.

Extractables and Leachables Testing: An Introduction and Strategies in Current Practice

Our white paper explores E&L testing's importance in safeguarding drug product integrity. Gain insights, strategies, and benefits for seamless testing and market acceleration.

Patent Litigation and Product Liability: The Benefits of Partnering with a CRO

In cases of patent litigation or product liability, attorneys and consultants seek optimal outcomes for their clients by leveraging comprehensive resources, data, and expertise, as detailed in our white paper which outlines how engagement with a contract research organization (CRO) can deliver the necessary testing, analysis, and expert witness services for a successful resolution.

Glass Containers for Pharmaceuticals: Delamination and Interaction Studies

Glass delamination jeopardizes product quality; early evaluation via USP<1660>, predictive studies, and microscopy mitigates risks.

Polymer Rheology Case Study: Characterisation of the Physical Properties of Hyaluronic Acid Dermal Fillers

Polymer rheology testing links stress to material flow, crucial for product performance and optimization, saving costs, and minimizing waste.

Top-8 FAQs of Failure Analysis

Failure analysis investigates the root cause of product, component, or asset failures. It offers insights to solve issues, take corrective measures, and prevent recurrence. Explore the top 8 FAQs for a better understanding of the process, including what it includes, why something broke, and its ability to pinpoint the exact cause.

Using ISO 9001 or ISO 14001 to Gain a Competitive Advantage

Join over 1.1 million certified organizations and leverage QMS/EMS for business growth, market-entry, and supplier relationships through ISO 9001 or ISO 14001 certification.

White Paper: REACH Registration of Gases – Applications in Raman Spectroscopy

The REACH Regulation mandates comprehensive analysis of chemicals for import or production in Europe. While various techniques exist for characterizing solids and liquids, gas analysis options are limited. Raman spectroscopy emerges as a valuable tool for gas analysis, providing effective substance identification data for REACH compliance.

Understanding EN 71-3 New Chemical Migration Limits in Toys and Childcare Items

The European Toy Safety Directive (2009/48/EC) underwent a major revision in 2009, with chemical aspects applying from 2013. The revised EN 71-3 Standard has implications for toys and related articles in the EU market. This paper discusses compliance implications for manufacturers, importers, and retailers.