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APPLICATION
Parenteral and combination drug products
What particles are present, which material classes dominate, and what differs between batches? Compare product, packaging, device and process-related populations with experienced specialists, moving from particle findings to reviewed investigation evidence.
Small sample sets are typically reported within 1–3 business days, including final review.
Discuss this application
CUSTOMER QUESTION
Which population changed, and which materials deserve closer investigation?
Connect the particle finding to the product
Assess particle counts and material classes across batches, container-closure systems, devices and process interfaces.
Compare findings with tubing, stopper, syringe, packaging or formulation references to focus the next investigation.
Define the population that matters
Customer-defined size ranges, for example >1, >5 or >10 µm.
Raman classifications and representative particle images linked to measurement records.
Batch and reference comparisons designed around the product and process question.
Reviewed interpretation, not only spectra, developed in close collaboration with your team.
Result: Supplier A showed a PET-dominated particulate fingerprint, while Supplier B showed a distinct PP/PE-dominated profile.
Supplier A · n = 156 Raman-analyzed particles
PET · 126 · 80.8%
Polystyrene · 17 · 10.9%
Epoxy · 7 · 4.5%
Cellulose · 4 · 2.6%
Polyethylene · 1 · 0.6%
Unknown ester · 1 · 0.6%
Supplier B · n = 129 Raman-analyzed particles
Polypropylene · 67 · 51.9%
Polyethylene · 29 · 22.5%
Cellulose · 11 · 8.5%
Polystyrene · 7 · 5.4%
Polyamide · 6 · 4.7%
Acrylic/Methacrylate · 4 · 3.1%
Unknown ester · 3 · 2.3%
Epoxy · 2 · 1.6%
A comparative material fingerprint from two Raman-analyzed populations. Percentages describe the analyzed subsets; this example does not establish statistical equivalence.
Analytical workflow
1 · Define scope and size range
Frame the product, packaging, device and process question.
2 · Prepare and count
Prepare representative particle populations for imaging and Raman targeting.
3 · Automatically target Raman
Acquire calibrated morphology and automatically direct Raman measurements to the study-defined particle population.
4 · Compare batches and references
Compare candidate reference materials where available.
5 · Interpret and review
Report class patterns, unresolved classes and practical follow-up options.
Deliverables
Defined counts, configurable size-class results and Raman material-class summaries.
Linked images, calibrated morphology, measured spectra and representative particle evidence.
Batch comparison and a reference comparison matrix where suitable references are available.
Specialist interpretation informed by application, process and device context.
Supporting raw data and technically reviewed, independently quality-reviewed reporting within the agreed scope.
Configurable size classes
Typical configurable classes include 0.5, 1, 2, 5, 10, 25, 50 and 100 µm. The approximately 0.5 µm lower working range depends on material, matrix and preparation; the suitable reporting range is established for the study.
Explore automated particle Raman analysis
QUALITY AND TRACEABILITY
Reviewed evidence for a focused investigation
Unknown particles can be compared with customer-supplied materials and relevant spectral references. A sufficiently discriminating reference set and sampling design can support identification of a probable source and focused root-cause/CAPA work.
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