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Contamination Analysis

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Contamination Analysis

Contamination analysis is the practice of detecting, identifying, and determining the source of foreign material in or on a given material sample through the application of materials and surface science techniques.

Lucideon’s expertise and experience, coupled with our extensive state-of-the-art range of analytical capabilities, ensures that we can offer a rapid and accurate service across pharmaceuticals and medical devices.

Contamination Analysis

 

Rapid processing

When you have production on hold, or product in quarantine, time is critical. Lucideon can save you time with immediate priority access to world-class expertise and analysis that will help you to solve the issue.

Our focus on analysis & evaluation suits a consultative approach, allowing us to go the extra mile for our clients. Contaminant analysis provides valuable insights into the sources and causes of impurities.

Using this information, problems can be resolved at their cause thus reducing costs and risk of product recall.

 

Flexible analysis

We investigate foreign material and contaminants in pharmaceutical raw materials, intermediaries, and finished products with capabilities including but not limited to powders, tablets, capsules, creams, injectables, and packaging.

Investigations in medical devices include foreign material, stains, discolouration, and defects on orthopaedic and vascular implants, delivery devices, coatings, and packaging. We also quantify and characterise particulates (number, sizes, morphologies, compositions) released from medical devices.

Foreign materials we have identified include material fibres, dust, hair, skin, biological material from plants and insects, coating particles, packaging particles, wear debris including metals, glass and polymers, machining oils and lubricants, and polymer additives.

 

Certified experience

We have extensive experience working with pharmaceutical manufacturers, medical device manufacturers, contract research organisations (CROs), and quality control and regulatory compliance laboratories.

In the UK Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our Pharmaceutical/GMP Laboratories hold an MHRA Certificate of GMP Compliance (No. UK GMP 43644 Insp GMP/IMP 43644/10698843-0005, Dated:28/07/2020) for contract QC Testing of Human and Veterinary Medicines. The Lucideon Pharmaceutical/GMP Laboratories also hold a current FDA Certificate of Registration and were successfully inspected by FDA in September 2019.

» View more information on our accreditations here

 

Analytical techniques include:

  • Light Microscopy
  • SEM (Scanning Electron Microscopy)
  • FEG-SEM (Field Emission Gun SEM)
  • EDS (Energy Dispersive X-ray Microanalysis)
  • FT-IR (Fourier-Transform Infrared Analysis)
  • ToF-SIMS (Time-of-Flight Secondary Ion Mass Spectrometry)
  • GC-MS (Gas chromatography-mass spectrometry)
  • LC-MS (Liquid chromatography-mass spectrometry
  • ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy)
  • ICP-MS (Inductively Coupled Plasma Mass Spectrometry
  • AAS (Atomic Absorption Spectroscopy)
  • DLS (Dynamic Light Scattering)
  • EPMA (Electron Probe Microanalysis)