Pharmaceutical
Hauser Laboratories supports
cGMP Pharmaceutical Manufacturers in fulfilling their FDA-mandated
obligations to investigate out-of-compliance and out-of-control events. We
are expert in identification of contaminants and unknowns found in process
streams, filters, and finished products. We can identify corrosion products
and degradation products and link them with their sources. We test for
materials compatibility, qualify alternate materials and processes, and
perform process equipment calibrations. We provide our pharmaceutical clients
with third-party investigation reports that are detailed and complete, but
are also strictly limited in scope to the specific situation investigated.
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- Analytical Support
- General Analytical
Testing
- Analytical Method
Development
- Method Validation
- Trace Impurities
Identification
- USP/NF-Monographs
- Degradation Studies
- Ozonolysis
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(Scanning
Electron Microscopy with Energy
Dispersive Spectroscopy is used to identify
contaminants, corrosion products, and other
abnormalities in process streams and finished
products.)
EXAMPLES OF PHARMACEUTICAL EXPERTISE
Contaminant Identification of a Pharmaceutical
A large pharmaceutical manufacturer needed help identifying the cause of tiny
black particles that were discovered during equipment maintenance. Hauser
Laboratories used FTIR and SEM analyses to identify the black particles as
small pieces of silicon based material. This identification allowed us to
trace the particles back to an O-ring that was breaking down during the
process.
Verification of Process Equipment
Hauser Laboratories was approached by a pharmaceutical manufacturer that
wanted to verify the composition of its process equipment. Hauser
Laboratories used SEM-EDS to identify the metal composition and verify that
it was stainless steel 316.
Sterility Verification
Hauser Laboratories was able to assist a pharmaceutical client in determining
the effectiveness of its sterilization process. FTIR was used to examine the
client’s glassware post sterilization to make sure no harmful residues
remained.
Verification of Raw Materials
Hauser Laboratories assisted a pharmaceutical manufacturer in verifying that
their shipments of glacial acetic acid used in their process, met USP
standards before the shipment was accepted.
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