Facility and Technical Services

LabelerOur FDA registered cGMP facility has over 25,000 square feet of state-of-the-art capability, with current capacity for tablet and capsule manufacturing exceeding 1 million per month. Vesta's commitment to quality is exemplified by our onsite, full service quality control lab. cGMP requirements include: complete compendia testing for RM's; analytical method validation; manufacturing process validation; cleaning validation; and annual product review. Vesta's equipment inventory includes a chemistry laboratory outfitted with a fume-hood, pH meter, two spectrophotometers, two High Performance Liquid Chromatography (HPLC) systems, and various testing, measuring, and weighing equipment competent for testing material quality. Our manufacturing capabilities are enhanced by: a Littleford plow style granulator and ribbon blender for granulation; Fitzmill and Quadro Comil sizing equipment; Double cone (10ft3 and 100ft3) and Twin Shells (16 quart and 30ft3) units for blending; Manesty Beta press, Manesty Versa press and a Fette P2000 for compression; a 24 inch Accela Cota for coating; and full packaging capabilities of 12,000-18,000 bottles/day.

Mixer

Formulation and Process Development

  • Blending, drying, granulation and coating development
  • Brand extension formulation development
  • Dosage form specification development
  • Excipient compatibility studies
  • Excipient selection and ration determination
  • Formulation of drug products: solids and semi-solids
  • Immediate release dosage form development
  • Manufacturing process optimization
  • Modified and sustained release dosage form development

Formulation Evaluation

  • Compressibility evaluation
  • Content uniformity evaluation
  • Disintegration testing
  • Dissolution testing
  • Friability testing
  • In-vitro bioequivalence determination
  • Powder flow determination
  • Stability assessment
  • Tap-density testing

Clinical and Small to Large Commercial
Manufacturing and Small Scale Phase III

  • cGMP Manufacturing
  • Dosage form preparation and blending
  • Granulation, tableting, encapsulation and coating
  • Open and blended clinical packaging and labeling
  • Semi-automated encapsulation and coating

Regulatory Support & Consulting

  • Facility & Process Validation

Analytical Method Development/Validation

Development and validation of analytical methods in support of stability testing of drug substances and drug products, residual solvent testing and cleaning validation testing.

Raw Material/Excipient Testing

Testing performed according to the USP, EP, BP, JP or FCC Compendia, or performed according to client-supplied or vendor-supplied methods.

Stability Testing and Stability Storage

Testing performed to support national and international regulatory submissions for new products.' Commercial product stability programs also supported.' Stability storage capabilities with a broad range of storage conditions including all ICH conditions for long-term or accelerated stability studies as well as photostability studies.

Comparative Product Testing

Development and validation of assay, impurity and dissolution methods for over-encapsulated and/or de-branded marketed products.
Testing performed to support clinical release, clinical re-assay and stability programs.

Marketed Product Release Testing

QA/QC release testing performed to support marketed products.

 

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