RQM+ Medical Device and In Vitro Diagnostic Blog

on 24 April 2020 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Dynamic mechanical analysis, sometimes abbreviated to DMA, is a workhorse technique used to investigate the various mechanical properties of materials as a function of frequency, temperature, and time. The goal is to ultimately get an in-depth assessment of the stress and strain...

on 17 February 2020 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Scanning electron microscopy (SEM) is an advanced analytical tool that vastly outstrips the capabilities of traditional light microscopy. The standard array of magnifying lenses in a compound microscope enables sample magnification by up to 1000x, using visible wavelengths of...

on 11 September 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

The acronym GMP refers to the good manufacturing practices promoted by the U.S. Food and Drug Administration (FDA) under the remit of the FD&C Act; which mandates strict levels of quality assurance at every stage of the pharmaceutical manufacturing chain. Although GMP principles...

on 20 August 2019 | By Kevin Rowland, RQM+ Director of R&D

The molecular weight of proteins, natural and synthetic polymers is a clear indicator of product performance and activity. To control product performance across a broad range of applications, the understanding of molecular weight determination is key.

on 21 June 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Polymer molecular weight (MW) is the molecular mass of a polymer chain. While small molecules of the same elemental composition all exhibit the same molecular weight, polymer chains exhibit different characteristics. These chains are compounded from multiple small molecules that...

on 22 May 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Elemental analysis is a process in analytical chemistry in which a sample of material such as water, minerals and bodily fluid is analyzed to ascertain its elemental composition. Elemental analysis can be qualitative, determining which elements are present or quantitative,...

on 27 February 2019 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting

Gel Permeation Chromatography (GPC) is a powerful technique that provides a direct measurement of molecular weight, a critical property in characterizing natural and synthetic polymers. There is no universal GPC system with the capability to separate every polymer-based...

on 1 February 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

X-ray diffraction is a powerful method of characterizing crystalline materials in a non-destructive manner. It is often used to identify and quantify crystalline phases by illuminating samples with a beam of X-rays and analyzing the distinctive diffraction patterns emitted from...

on 25 January 2019 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Protein characterization is an incredibly broad field of study that encompasses a wide range of analytical methods and techniques. Although biochemists have made enormous strides in protein analysis, the process of identifying and purifying novel proteins remains a daunting...

on 19 December 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Gel permeation chromatography (GPC) is a powerful analytical technique used to separate dissolved molecules by size, based on their elution from a column filled with a porous gel. I t can be described as a type of molecular sieving chromatography, where samples are separated...

on 26 October 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Polyethylene is the most pervasive synthetic polymer used worldwide, comprising over a third of the world’s annual plastic manufacturing output. Production of plastics has come under significant environmental scrutiny in recent years with estimates suggesting that as much as...

on 10 October 2018 | By Kevin Rowland, RQM+ Director of R&D

Transmission electron microscopes (TEMs) are the big guns of the microscope world, capable of peering far beyond the diffraction limit of conventional optical microscopes to resolve sub-nanometer details and probe the atomic structure of materials. [1] The most sophisticated...

on 8 October 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Thermogravimetric analysis, or thermal gravimetric analysis (TGA), is a method of determining the overall mass of a sample as a temperature-dependent property. Mass change as a function of temperature is a fundamental property of many materials as they degrade and lose volatile...

on 18 April 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

No two polymers are the same. They exhibit different properties depending on key characteristics, such as their molecular weight. Polymer molecular weight (MW) describes the molar mass distribution of a polymer chain, which determines the weight of the macromolecule itself. This...

on 13 April 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Transmission electron microscopy (TEM) is a form of microscopic analysis that transmits a high-energy beam of electrons through an ultrathin sample specimen. This provides imagery based on the transmission/attenuation of electrons, which is then magnified for direct observation...

on 30 March 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Failure analysis is used to detect chemical and mechanical defects and deficiencies in polymer products, which have contributed to or directly resulted in failure. It is a critical analytical field that can improve the efficiency and profitability of polymeric products,...

on 14 February 2018 | By By Kevin Rowland, RQM+ Director of R&D

Dynamic Mechanical Analysis (DMA) describes a procedure in which the mechanical properties of materials are measured as a function of time, temperature, and frequency. In basic terms, dynamic mechanical analysis involves the application of a stressor on a target such as the...

on 15 January 2018 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

The US Environmental Protection Agency (EPA) was established to protect human health by providing regulatory oversight and implementing decisive action where required. Changes in manufacturing protocol and emergent materials mean that the powers of the EPA are routinely subject...

on 27 November 2017 | By Kevin Rowland, RQM+ Director of R&D

E&L testing is carried out on plastic products to understand which molecules, such as antioxidants, slip agents, surfactants lubricants, etc. are released from a polymer system. Undertaking E&L testing is a critical step of the medical device and pharmaceutical safety...

on 18 October 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

New generation Resolve Columns (7.8 mm x 300 mm) are produced to allow separation over the molecular weight range from 500 to 12,000,000 g/mol (PS equivalent) for 13 µm particle size packing materials. Polyolefins often have broad molecular weight ranges characterized by high...

on 14 July 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

E&L testing is a critical process in pharmaceutical packaging development and medical device manufacturing. Unlike many other forms of laboratory analyses, it cannot be broken down into a series of simple methods. This is primarily due to the complex and infinitely variable...

on 19 April 2017 | By Kevin Rowland, RQM+ Director of R&D

Titrimetry is an important analytical process used to determine the quantity of specific constituents in a mobile phase. It is a type of volumetric analysis where the analyte is quantified as a function of equivalence, which is expressed as a titration curve with an end point...

on 10 April 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Extractables and leachables testing – E&L testing for short – is the process of identifying and quantifying the molecules which can be released from plastic-containing products. This blog post discusses the many different analytical techniques which are used to analyze sample...

on 4 April 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Polymers are ubiquitous materials used in construction, engineering, and countless commercial products. These applications can be as varied as the polymeric materials used in medical devices, pharmaceuticals, food and beverage packaging, and personal care cosmetics. They are...

on 31 March 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Process and quality control in the pharmaceutical industry requires highly-discerning contaminant detection, including particulates and residue analysis. These elements are among the primary forms of contamination in the pharmacological industry, and can arise from a broad range...

on 29 March 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

ISO 10993 comprises a series of international standards for the evaluation of biomedical devices and associated biological risk. ISO 10993 includes specific standards for certain material classes, such as ceramics or metals, as well as evaluation and testing within a...

on 20 March 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

There are various well-established methods of carrying out particle analysis including dynamic image analysis (DIS), static light scattering (SLS), and sieve analysis—sometimes called gradation testing. These methodologies can often be complementary, each providing information...

on 16 February 2017 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

One of the most common methods for analyzing protein characteristics and measuring protein purity in solution is to observe the sample’s absorption of ultraviolet (UV) wavelengths of light. Proteins that contain the appropriate amino acids are absorbent to light on the...

on 25 January 2017 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting

What is a Toxicological Risk? Toxicological risk measures the probability of an adverse effect being caused by a given compound. This covers effects such as skin irritation from topical treatments to more serious risks such as a material being carcinogenetic or fatal if ingested.

on 17 November 2016 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting

A biological evaluation plan is developed to systematically assess whether a device intended for use in humans poses an unacceptable biological safety risk.

on 14 October 2016 | By Kevin Rowland, RQM+ Director of R&D

Gel permeation chromatography (GPC) is a well-known method which is used for characterizing polymers according to their molecular weight distribution. The gel permeation chromatography analysis of engineering plastics at high temperatures needs specialized instruments and...

on 1 August 2016 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Drug and dietary supplement manufacturers face an increasingly complex set of elemental impurity standards, which we will detail here.

on 6 July 2016 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

At RQM+ Lab Services , our team of expert lab technicians utilize a range of testing methods to deliver precise results for specific customer requirements. Where water determination is the primary ob j ective, we often deploy the Karl Fischer titration method; the...

on 14 April 2016 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Just one mammalian cell is made up of a combination of many distinct proteins, often to the degree of thousands in varying concentrations. The variety and magnitude of protein types within just micro volumes of a single sample micro present substantial challenges for...

on 1 February 2016 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting

Biological safety evaluations are designed to assess whether a product is safe for its intended use depending on its composition. For example, an evaluation of a cardiovascular implantable device would need to assess potential risks associated with long term contact with blood...

on 4 January 2016 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting

The Food and Drug Administration (FDA) partially recognized the ISO 10993 guidance making it one of the most important for the chemical characterization testing of medical devices.1 ISO 10993 outlines all of the necessary steps for regulatory compliance to use new or existing...

on 2 November 2015 | By Kevin Rowland, RQM+ Director of R&D

An important step in determining the biological compatibility and safety of a medical device as required by ISO 10993 is chemical characterization. Extractables and leachables testing is a vital but complex part of this. There is no one-size-fits-all approach that can be...

on 7 August 2015 | By Kevin Rowland, RQM+ Director of R&D

Determining the structural, chemical and functional properties of proteins is of vital importance to an increasing range of biopharmaceutical and life science markets. This is conducted repeatedly throughout the research and development (R&D) process for initial characterization...

on 15 April 2015 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Making the choice between a real or ‘fake’ Christmas tree can be a tough family decision. While there are many reasons to choose artificial (no needles, doesn’t dry out, cheaper over time), possibly the best reason is safety.

on 27 March 2015 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Extractables and leachables are chemicals that can be extracted from a product such as a syringe and deposited into the product it is housing. This can be either in the presence of a solvent or through direct contact over an extended period of time. An extractable and leachable...

on 11 March 2015 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Product deformulation is a complex analytical process designed to uncover the specific chemical identity of finished goods. Chemists take the product of interest, break it down into its constituent parts, separate those into distinct entities, then analyze both the major and...

on 10 March 2015 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Thermo gravimetric analysis (TGA) is a thermal analysis technique used to quantify the overall mass of a sample as a temperature dependent property. The change in mass as a function of temperature is a key property in a range of materials because they lose volatile components as...

on 6 March 2015 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Bis(2,4-di-tert-butylphenyl)-phosphate (bDtBPP) has been the subject of much discussion in the area of Extractables and Leachables testing for single use bioprocess systems.

on 10 December 2014 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Chemical reverse engineering is an extremely valuable process for those looking to protect their intellectual property from manufacturing issues or patent infringements. It is also deployed to help manufacturers maintain a competitive edge through targeted product analysis. Each...

on 1 December 2014 | By Kevin Rowland, RQM+ Director of R&D

Understanding how and why materials degrade and ultimately fail is a critical step in the research and development (R&D) process. Compared to the lifespan of traditional engineering materials, polymers tend to fail in comparatively short timeframes. It is one of the reasons that...

on 7 October 2014 | By Kevin Rowland, RQM+ Director of R&D

Particulate contamination analysis using microscopy and spectroscopy methods can identify and mitigate contamination in chemical, consumer products, industry or processes. Particulate analysis is the first stage in resolving contamination issues that could be potentially...

on 17 September 2014 | By Kevin Rowland, RQM+ Director of R&D

The world of liquid chromatography has come a long way since the first online detectors for HPLC systems became available. At that time sixty some years ago, refractive index and conductivity detectors were all that was available, but neither provided the sensitivity that would...

on 12 May 2014 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Given the level to which plastics, rubbers, and other materials have impacted modern life, it is easy to see the importance of in-depth polymer analysis. By exploring critical parameters like molecular weight (MW), structure, morphology, and thermal characteristics, chemists can...

on 6 December 2013 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Risks assessments are a key element in extractables and leachables testing. There are many factors involved in ascertaining the specific risks and how this ultimately impacts the biocompatibility of a medical device.

on 22 November 2013 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Analyzing the molecular weight of both natural and synthetic polymers is extremely complex, and almost impossible to carry out with exactness. Unlike elemental analysis – which focuses on the chemical composition of samples under test – molecular weight analysis considers the...

on 11 September 2013 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Chemical analysis for leachables is one of the the primary methods used to assess the risk to patients and consumers from substances which leach from pharmaceutical packaging, medical devices and food packaging. A number of high-profile incidents have demonstrated that...

on 3 July 2013 | By Mark Jordi, Ph.D., RQM+ Principal Advisor

Container systems for drug products should not release any chemicals which can build up in quantities that could create a risk of toxicity or impact the stability or efficacy of the drug. Extractables and leachables refer to compounds which can be either extracted or leached...

on 23 April 2013 | By Kevin Rowland, RQM+ Director of R&D

The goal of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard covers testing for genotoxicity, carcinogenicity, cytotoxicity and a variety of other areas of concern. While the standard covers specific areas of testing to...

on 20 January 2012 | By Kevin Rowland, RQM+ Director of R&D

At RQM+ Lab Services, we pride ourselves on our scope of expertise. We rely on a fully grounded comprehension of long-standing and cutting-edge chemical testing methods. This enables us to deliver results via a limitless range of finely tailored analytical workflows. Our PhD...

on 4 January 2012 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Dynamic light scattering is a fundamental technique in particle measurement and characterization. It is widely used to illuminate the dimensions of particles in samples as well as their biomechanical and chemical characteristics under distinct conditions.