Pharmaceutical Microbiology Testing, Stability Testing & Raw Material Testing Services At Lancaster Laboratories

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Lancaster Laboratories - Analytical Services Lancaster Laboratories - Analytical Services

Pharmaceutical Products & Services Pharmaceutical Products & Services

 

Our Analytical Services

Lancaster Laboratories covers a wide range of contract analytical laboratory services, including microbiology testing, stability testing, raw material testing, and analytical method development and validation. With our strict adherence to cGMP requirements and our strong commitment to client service, we can operate as a capable extension of your own in-house laboratory.

Microbiology Testing Services

Microbiology Testing Services

Sterile Product Testing

  • Sterility
  • Endotoxiin
  • Particulate matter
  • Microbial immersion studies
  • Organism identification

Non-sterile product testing

  • Microbial limits
  • Antimicrobial preservative effectiveness
  • Bioburden studies
  • Organism identification

Facility validation support

  • Cleaning validation
  • Process water testing
  • Environmental monitoring
  • Consulting

Chemistry Testing Services

Chemistry Testing Services

Stability Testing and Stability Storage

  • Stability testing for national and international regulatory submissions for new products and API’s
  • Stability testing for commercial product stability programs
  • Experience in testing virtually all types of formulations, including aerosols.
  • Stability chambers accommodate all ICH conditions, including photostability

Raw Materials Testing

  • Raw materials testing to support formulation development, to support production, and for the qualification of vendors
  • Raw materials testing performed according to the following compendia: USP/NF, EP, BP, JP, ACS, or FCC, or performed according to client- or vendor-supplied methods

Analytical Method Development and Validation

  • Stability indicating assays for API’s and drug products
  • Impurity assays
  • Product release testing methods
  • Dissolution methods
  • Cleaning validation analysis (specific and non-specific methods)
  • Extractable and leachable assays

Comparator Product Testing

  • Development and validation of assay, impurity and dissolution methods
  • Stability studies
  • Clinical release
  • Clinical re-assay

Product Release Testing and Retain Program Administration

  • QA/QC release testing performed to support marketed products.
  • Services provided to store and inspect commercial product retain programs

Consulting Services

  • Analytical method validation and transfer protocols
  • Analytical method transfer final reports
  • Cleaning validation protocols with respect to analytical methods and swabbing techniques
  • Stability study protocols
  • Environmental monitoring services, including on-site sample collection

Lancaster Laboratories

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Address

Lancaster Laboratories - Address Lancaster Laboratories, Inc.
  2425 New Holland Pike
PO Box 12425
Lancaster
PA 17605-2425
USA
Tel. +1 717 656 2300
Fax +1 717 656 2681

 

 

 

 

 

 


 
 
 
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