Contract Manufacturing

FACILITIES

Our manufacturing facility in Columbia, SC

• ~120,000 sq. ft. manufacturing and packaging facility
• Over 900 million unit dose vial capacity
• US-FDA approved
• Fill volume range from 0.25 mL – 15 mL
• On-site compounding
• From development to full scale commercial batches
• Batch size 250L – 1800L
• USP grade WFI processing facility

• Sterile product transfer and holding
• Filling space class 100
• Real time environmental monitoring and control.
• Automated online integrity testing
• Automated packaging
• Automated material handling
• Packaging speed range 20 – 400 parts per minute


QUALITY UNIT

In order to provide a full service experience to its customers, TRC has invested in and maintains all required Quality Control and Assurance full analytical and QA functions providing services in development, transfer, and validation of analytical methods in support of product formulation, stability studies, validation studies, and commercial manufacturing.


Analytical Chemistry

• Wet Chemistry
• Chromatography
• Compendial Testing
• Stability Testing
• Instrumental Analysis
Raw material and finished product release



Microbiology

• Bio-burden testing
• Sterility testing
• Compendial Testing
• Viable environmental monitoring
• Organisms identification
• Media fills
• Stability testing


Quality assurance

• Integrated real-time process monitoring and control
• Document Management
• Batch record review and release
• Supplier Management
• Change control



Validation

TRC recognizes validation as an integral part of a product’s life cycle and quality assurance and so, it maintains an in-house validation team dedicated to supporting qualification activities at TRC in the following areas:

• Design Qualification
• Equipment Qualification
• Automation Qualification
• Computer Validation
• Cleaning Validation
• Equipment Sterilization Validation
• Process and Product Validation