Drug Development Solutions
Foreign Particulate Matter
The presence of Foreign Particulate
Matter (FPM) in pharmaceutical and
biopharmaceutical products affects their
quality and safety, leading to loss of
batches, plant shutdowns, product recalls
or regulatory action. FPM contamination
still remains as one of the leading causes
for product recalls1.
Manufacturers of pharmaceutical and biopharmaceutical
products are required to demonstrate a thorough understanding
of their processes which includes carrying out appropriate
investigations to determine the identity and origin of any
contamination that may occur.
The size and count of particulate matter are critical factors when
considering the potential risk to patients. Therefore, Particulate
Matter Testing forms a part of the regulatory requirement to
ensure that unintended and non-therapeutic particulates in
products do not exceed established limits.
Particulate matter can be classed as being visible (>100µm) or
sub-visible (1-100µm). We support the following routine tests for
both visible and sub-visible particles:
• USP Sub-visible Particulate Matter in Therapeutic
• USP Particulate Matter in Injections
• USP Particulate Matter in Ophthalmic Solutions
• USP Visible particulates in Injection
• USP Methods for the Determination of Particulate
Matter in Injections and Ophthalmic Solutions
All sample preparation is performed in Class 5 laminar flow
cabinets and our staff are trained in aseptic and sterile handling
techniques to minimise contamination.
Identification of particulate matter contamination and
determination of the source of origin is essential for root cause
analysis investigations. With many years experience in both
pharmaceutical and forensic analysis, our staff have in-depth
knowledge and expertise in a wide range of foreign particulate
types and their likely origins.
We are, therefore, able to design and carry out such
investigations in the most timely and cost effective manner thus
minimising disruptions and delays to the manufacturing process.
Science for a safer world
LGC, Queens Road, Teddington,
Middlesex, TW11 0LY
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recording or any retrieval system, without the written permission of the copyright holder. LGC Limited, 2018. All rights reserved. HSI/0148/CS/1018
For further information on how LGC can
assist with Foreign Particulate Matter,
please contact us:
Our technical capabilities and expertise include:
• Isolation of FPM (as small as 25 µm) from a variety
of matrices (API, raw materials, tablets, solutions,
suspensions, creams) using appropriate techniques
e.g. filtration, micro-extraction, pipetting and
• Microscopy for information on particle appearance,
size, morphology, crystallinity, homogeneity and
• Fourier Transform Infra-Red (FT-IR) Spectroscopy
and Microscopy for determination of chemical
composition. FT-IR mapping can identify
components of a heterogeneous mixture without
having to isolate each component. Our extensive
spectral libraries (with over 260,000 spectra) allows
for identification of the component.
• Scanning Electron Microscopy/Energy Dispersive
X-ray (SEM/EDX) analysis for elemental composition
e.g. determination of the alloy type or grade of
stainless steel for metallic contamination.
• Powder X-ray Diffraction (PXRD) for identification
of crystalline particulates (e.g. minerals, organic
powders). PXRD can also be used to determine
crystallinity and differentiate between polymorphs.
• Mass spectrometry (GC-MS, LC-MS) for structural
• Inorganic trace analysis using ICP-OES and ICP-MS.
We routinely analyse reference materials (i.e. suspected
sources of contamination) and compare them with the
FPM in order to determine its origin. We can also build
a searchable reference library consisting of typical
materials your product might come into contact with for
quick comparison and identification.
Depending on the nature of the particulate matter and
the process or product matrix we will tailor our work
package to provide the most efficient and cost-effective
solution for you.
Aerial photo of LGC’s Fordham, UK site
(SEM / EDX)
(PXRD, MS, ICP)
Figure 1. Typical approach taken for Foreign Particulate