Element Materials Technology
W: www.element.com
LinkedIn: Element Materials Technology
Twitter: @ElementTesting

Toronto, Canada
2395 Speakman Drive
Mississauga, ON L5K 1B3, Canada
T: +1 905-822-4111
F: +1 905-823-1446
info.toronto.pharma@element.com
Santa Fe Springs, California
9240 Santa Fe Springs Road
Santa Fe Springs, CA 90670
T: +1 562-329-4390
F: +1 562-948-5850
info.santafesprings@element.com

 

ALG Minneapolis
1285 Corporate Center Drive
Suite 110
Eagan, MN 55121
T: (877) 287-8378
info@analyticallabgroup.com
ALG Boston
33 Nagog Park
Acton, MA 01720
T: (877) 287-8378
info@analyticallabgroup.com
ALG San Francisco
2341 Stanwell Drive
Concord, CA 94520
T: (877) 287-8378
info@analyticallabgroup.com

 

Element is your partner of choice. Through our global network of laboratories we offer a broad spectrum of pharmaceutical development and testing services. Our core services include analytical method development; batch release; API and raw material analysis; organic and elemental impurities determination; plastics and polymer testing; analytical testing in support of clinical trials; microbiology product testing; environmental monitoring; USP sterility and rapid sterility testing; molecular cell biology & virology testing; and stability studies. Element is a leader in providing risk-based extractables and leachables programs and USP <797> compliance solutions.


UPCOMING WEBINARS

Physical Characterization of Solids in the Pharma Industry

December 10, 2020

Join Ben Vanasse, Chemistry, Manufacturing and Control (CMC) Specialist for a live webinar on the physical characterization of pharmaceutical products. He will provide detailed examples to help you understand how the physical nature of a drug or drug product can impact its behavior in the body.

ON-DEMAND WEBINARS

The Future Role of ICPMS-QQQ in the Pharmaceutical Industry

Bassem (Sam) Ebaid, Senior Chemist and Element’s ICPMS-QQQ subject matter expert, guides you through the history of ICPMS-QQQ as well as its future role in the pharmaceutical industry.

 

Raw Materials Testing and CGMP Stability Services
What is raw materials testing? How does it work? What information does the testing provide? When should I use it?

Ben Vanasse, Chemistry, Manufacturing and Control (CMC) subject matter expert at Element, provides an overview of raw materials testing and CGMP stability services.

USP <761> Qualitative & Quantitative NMR Analysis
What is Magnetic Resonance and how does it work? What information does the NMR spectrum provide? Element’s on-demand webinar on qualitative and quantitative NMR analysis provides you with information on when to use NMR and how to characterize molecules qualitatively and quantitatively.

 


WHITE PAPERS

Case Study: Detecting Contamination in Pharmaceutical Products
Particulate identification and analysis are crucial steps towards resolving suspected contamination of products. The article provides an understanding of contaminant analysis techniques, such as light microscopy, FTIR spectroscopy, SEM coupled with EDS, along with a case study.

Article: USP <660> – Testing Glass Containers for Their Chemical Stability
The USP enforces rigorous testing requirements for containers and their closure system as they must not interact physically or chemically with the substance in any way that would alter its quality. This article explores the requirements and regulations for pharmaceutical glass containers as well as the testing involved.

 


NEWS


Element Scales its Health Sciences Business With ALG Acquisition

Element Materials Technology (Element) has acquired industry leading pharmaceutical testing business, Analytical Lab Group (ALG) from Thompson Street Capital Partners, significantly strengthening Element’s market position in pharmaceutical testing in North America and another important step in growing its Life & Health Sciences segment.

SERVICES

Preclinical

  • Toxicology test design
  • Toxicological evaluation
  • Formulation development
  • Pre-formulation analysis
  • Microbiological testing

Analytical Testing

  • Solid-state characterization (polymorphism, XRD, DSC, microscopy)
  • Medical device physical deployment testing (syringe actuation force, implant deployment, mechanical properties of biomaterials, etc.)
  • Medical device 510 K
  • Raw Material Excipient and API testing following USP, NF, & EP
  • Trace Metals Impurities
  • Heavy Metals Testing <232> ICHQ3D
  • Development and validation methods for assays and impurities/degradants
  • Analytical testing to support stability
  • Forced degradation
  • Compendia testing (USP, NF, FCC, EP, BP, JP, ACS, etc.)
  • Identification analysis for active pharmaceutical ingredient
  • Microbiological testing
  • Extractables from container closure systems, SUS, manufacturing bioprocessing equipment, and medical devices
  • Leachables from container closure system into drug product
  • Drug product release testing
  • Complementary analysis of dosage forms
  • Stability indicating assay development, validation
  • Stability storage (ICH)
  • Pharmaceutical packaging compatibility
  • NMR (GMP Compliant) and Q-TOF
  • Particle sizing and characterization
  • Contaminant Investigation
  • Polymer testing and prototype development

Microbiology Testing

  • USP <797> <800> compliance solutions
  • Environmental Monitoring
    • Includes cleanroom validation (IQ/OQ/PQ)
  • USP <71> sterility testing
  • Rapid sterility testing using BacT/ALERT®
  • USP <51> antimicrobial effectiveness testing
  • USP <61> <62> microbiological examination of nonsterile products
  • USP <81> antibiotic potency testing
  • USP <85> bacterial endotoxins
  • USP <1072> disinfection qualification
  • USP/EU water testing
  • Air/gas analysis
  • Molecular cell biology & virology testing
    • Mycoplasma
    • Cytotoxicity
    • Cell banking