Pharmaceutical Packaging Services in Raleigh, NC

Our focus is on moving pharmaceutical, animal health, and biotechnology products through the drug development pipeline faster by being agile, accountable, and transparent. 

Formulation and Analytical Development

• Technology/method transfer
• Method qualification
• Thermal characterization

Aseptic Filling

• Precise automated, gloveless filling done in a fully-enclosed isolator with no human intervention
• Vials, syringes, cartridges
• No minimum batch sizes

Testing Services

• Raw material testing – compendial and other QC release test methods for identity and CoA’s
• Release and stability testing (ICH)
• Analytical testing

Finishing Services Supporting Clinical Trials

• Labeling, re-labeling
• Kitting
• Packaging and inspection

Supply Chain Management

• Distribution and storage of API’s, finished goods, hazardous materials, CII-CV substances
• Sampling and dispensing capabilities for bulk material forms (liquids, powders, tablets)
• Clinical trial support and material distribution
• Available storage conditions include: 15-25°C, 2-8°C, -80°C

Simulated Distribution Testing

• Simulated distribution subjects the candidate formulation(s) to concurrent transport hazards of temperature, vibration, shock and pressure
• These hazards can be specified, controlled and set to the expected limits of the distribution process
• Total control is possible and samples exposed to simulated distribution may be analyzed to T0, and additional time points
• Typically, the sample results are compared to stability samples and thus demonstrate the physical stability of the protein solution 

Packaging & Material Handling Solutions

• ISO 9001:2008 certified quality management system
• Three cleanrooms (Class 100,000 / ISO 8)
• Engineering and manufacturing of medical device packaging solutions
• Design for medical devices using ISO 11607 / TIR22 guidelines
• Certified and traceable raw materials
• Full IQ/OQ/PQ validation capabilities
• Follow FMEA process control
• Statistical process control
• CNC tooling shop
• Rapid prototyping
• Quick time-to-market

Temperature Assurance Packaging & Product Cartons

PRODUCTS & DESIGN

• Folding cartons
• Mini-flute corrugated packaging
• Product authentication technologies
• Prepress and carton design services
• Insulated Shippers
• Durable & Reusable Containers
• Pre-Qualified Parcel Solutions
• Bulk Temperature Control Systems for Frozen, CRT and Refrigerated Applications

CERTIFICATIONS & COMPLIANCE

• ISO 9001:2008 Certified Quality Management System and cGMP Compliance
• G7 Master and G7 Process Control Certified
• GMI Prime Certification
• FSC/SFI/PEFC Chain of Custody Certification