• 5 cleanroom manufacturing suites
    • (2) ISO 8 certified rooms
    • (3) ISO 7 certified rooms
  • Filling performed in ISO 5 certified hoods
  • 25,000 liter WFI Quality tank through Reverse Osmosis based purification and automated loop sanitation cycle
  • Separate 25,000 Liter Saline tank and lines
  • Automated line capable of filling, labeling, and packaging 5,000 100 ml to 1 liter bottles per hour
  • cGMP to FDA21 CFR 820
  • ISO:9001:2015 Certified
  • FDA Registered
  • Hold 510 k’s for Medical Device Production
  • Packaging Capabilities
    • Rigid Containers 1 ml to 200 liters
    • Sterile Bioprocess bags 500 ml to 1000 liter
  • GMP warehouse and distribution
  • Onsite in-process laboratory supporting analytical and microbiology testing

Connect With Us

visit us

2714 South Miami Blvd. Durham, NC 27703

call us

Phone: 1-919-597-3500
Toll Free: 1-800-222-6921