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Infrastructure

Rubicon Research has a built in laboratory infrastructure incorporating state-of-the-art equipment and its facilities include the following

Formulation Development Laboratory» Analytical Development Laboratory »

Solid Dosage Forms

  • Rapid mixer granulator
  • Fluid bed processor with multiple attachments (including table top Glatt model)
  • Conventional coating pan, Perforated coating pan
  • Compression machines (including three layered tablet press)
  • Roller Compactor, Extruder, Spheronizer

Disperse Systems

  • Mixers
  • Homogenizers

Packaging

  • Unit dose Blister packing machine

These equipment help strengthen Rubicon’s resolve to achieve world class capabilities in processing solid dosage forms including coating of multi-particulate systems, dispersible tablets, OROS systems and liquid and semi-solid dosage forms and other disperse systems.

Development Facility for handling High Potency Compounds

The design of this formulation laboratory incorporates pressure gradients facilitating containment of particles, one pass air system in the area, reverse laminar airflow for protection of personnel, decontamination area of material and garments.

Analytical Method Development and Validations

Rubicon’s analytical wing is also geared to continue and consolidate its commitment to meet and surpass international standards. The embodiment of this attitude is reflected in its laboratory, which houses:

  • HPLC’s (with UV and DAD detectors) Automated systems with sample cooling arrangement and with column oven attachment from Agilent Technologies, Shimadzu Corporation, Waters, Dionex Corporation
  • Gas Chromatograph
  • UV Spectrophotometer
  • FTIR
  • Dissolution apparatus (USP I and II)
  • D.T Apparatus, Bulk Density Apparatus, Friabilator
  • Pall water purification system
  • Viscometer, pH meter etc
  • Shakers, sonicators, cyclomixer

Rubicon’s total analytical team supports system includes method development for dosage forms, validation of methods, drug release rate feedback, and evaluation of stability samples.

Stability Testing Facility

Rubicon has a stability facility for storage testing according to the ICH guideline and GLP norms.

Storage stations at –

  • 2 – 8 deg C
  • 25 deg C / 60% RH
  • 30 deg C / 65% RH
  • 30 deg C / 75% RH
  • 40 deg C / 75% RH
  • Photo stability chamber
  • Dry heat Oven (50/60 deg C in addition to above )

Microbiology Laboratory

Rubicon has started a Microbiology wing to estimate

  • Number of viable aerobic microorganisms present and freedom from designated microbial species in all pharmaceutical products
  • Detect the microbial load in Processed water
  • Preservative efficacy testing (PET) of pharmaceutical products and
  • Environmental monitoring

Quality Assurance

Rubicon’s QA team is competent to handle all documentation on

  • All Regulatory submissions
  • Out of specification results and atypical results
  • Change controls
  • Internal Audits
  • Training
  • Cleaning verification
  • Quality Manual and Water Manual
  • Destruction of material
  • Licenses and
  • Handling of Deviations

Documentation

All documents sent to clients are checked and approved by Quality Assurance and records (hard copies & soft copies) of all the documents are archived