EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS

503B HUMAN DRUG OUTSOURCING

Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.

Meeting the Sterile Product Needs of Drug Discovery

The typical compounding pharmacy does not have adequate resources or skill to handle medication preparation for clinical research. JCB and Fagron Sterile Services have the knowledge, experience and high-tech facilities to serve your needs as a research professional.

Pharmaceutical Research Services

Sterile Product Development
  • Aseptic filling
  • Sterilization
  • Batch Compounding
    • Multiple Vial Sizes
    • Syringes
    • Bags
    • Your Custom Delivery Device
  • Drug Master Formulas
    • Detailed Procedure of Entire Compounding Process
    • Detailed Lot Specific Records
    • Product name/ID
    • Medication strength
    • Medication form
    • Medication volume
    • Detailed Tracking of all API
Custom Labeling
  • JCB has the capabilities to tailor multiple labels to suit your needs
    • Primary labeling
    • Secondary labeling
Custom Packaging
  • Kitting
  • Variety of closure formats
  • Tamper evident packaging available
Analytical Services
  • State-of-the-Art Instrumentation
  • HPLC, GC, GC-FID, GC-MS, LC-MS/MS, FTIR, UV-Vis, Polarimeters, ELISA, Genetic Analyzer, Thermal Cyclers, Luminometers
  • Quality Control Data for Documentation and Validation
  • Analytical Method Development and Validation
  • Stability and Degradation Studies
  • Wet Chemistry/Compendial Testing
  • GLP/cGMP Compliant Testing
  • Dissolution
  • Particulate Matter
Microbiology
  • Sterility Testing and Bacterial Identification
  • Endotoxin Testing
  • Bioburden/Microbial Limits
  • Sterilization Validation Testing
  • Bacteriostasis/Fungistasis
  • Preservative Effectiveness Testing
  • Microbial Assays (Antibiotics)