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

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2714 South Miami Blvd. Durham, NC 27703