Product/Service

Consulting Services For Pharmaceutical Solid Dose Manufacturers

Consulting Services For Pharmaceutical Solid Dose Manufacturers

At CRB, we understand that each manufacturer has unique needs. That is why we tailor our services to each client, ensuring that the solution you achieve is the best for you and not what was best for the last client. From Greenfield designs and major renovations, to troubleshooting a single piece of equipment, no issue is too big or too small. We pride ourselves in being our clients' long-term partner.
 

When designing an encapsulation process, it is important to incorporate a level of design that will fit both the needs and the budget of the project. At CRB, we begin each design with our in-depth understanding of cGMP and regulatory guidelines. We focus our goals around protecting the specific critical quality attributes of the product, and streamline the process by identifying and controlling the critical process parameters. CRB follows this approach in order to ensure both the quality of your product and the efficiency of the process designed.

Fill Material

  • Powder
  • Liquid
  • Bead
  • Paste
  • Tablet
  • Mixed

Capsule Imprinting

  • Axial
  • Radial

Processing Influenced Attributes

  • Particle Size
  • Size Distribution
  • Particle Shape
  • Density
  • Porosity
  • Compressibility

Environmentally Influenced Attributes

  • Hygroscopicity
  • Light Sensitivity
  • Oxygen Sensitivity

Safety

  • Dust Deflagration Hazard
  • Occupational Exposure Limits

Blending Techniques

  • Direct Compression
  • Diffusive
  • Convective

Tamper Proofing Process Equipment

  • Blenders (Ribbon, Cone, V, IBC, etc.)
  • Regulatory Compliance
  • Compounding
  • Solution Preparation
  • Weigh/Dispense Booths
  • High Shear Granulators
  • Fluid Bed Processors
  • Tablet Presses
  • Capsule Fillers
  • Coaters
  • Printers
  • Gel Mixers / Melters
  • Gel Transfer Tanks
  • Encapsulators
  • Tumble / Tray dryers
  • Polishers
  • Sorters
  • Potent Compound Isolators
  • Metal Detectors
  • Packaging Equipment Lines
  • Bottle
  • Fillers
  • Blister
  • Powder

Process Utilities

  • Dust Collection / Dust Mitigation
  • Explosion Prevention
  • Solvent Recovery
  • Thermal / Catalytic Oxidation
  • Dehumidification
  • Bag-in / Bag-out (BIBO) Filtration
  • Room Pressurization Control
  • Cross-Contamination Prevention
  • CIP Systems
  • Vacuum
  • Compressed Air
  • RO / DI
  • Purified Water
  • Nitrogen
  • Steam (Clean / Plant)
  • Solvent Containment
  • Class 1/Division 1 and Class 1/Division 2 (Solvents)
  • Class 2/Division 1 and Class 2/Division 2 (Dusts)
  • Uninterrupted Power Supply (UPS)
  • Emergency Power Generation

Architectural Design

  • Facility Master Planning
  • Feasibility Studies
  • Environmental Health and Safety (EH&S) Requirement Incorporation
  • Building Code Analysis and Compliance
  • Insurer Compliance
  • Lease Consultation
  • Risk Analysis
  • Material / People / Waste Flow
  • Regulatory Compliance
  • Productivity Maximization
  • Cross Contamination Minimization
  • Light Sensitive Product Space Design
  • Staging (WIP) and Circulation Space Planning
  • Ergonomics
  • Support Space Optimization
  • Controlled Substance Environment Design
  • Facility Security
  • Pest Control
  • Equipment Delivery and Access
  • High Hazard Area Design
  • Passive Fire Protection Design