AAIPharma strengthens sterile product release capabilities
US-based AAIPharma has completed upgrades of more than US$2m to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina.
Improvements were made to increase capacity and to ensure compliance with European Union (EU) aseptic processing and testing guidelines, positioning the facilities to be approved for aseptic filling and release of products exported to the EU.
The upgrade in the Charleston facility significantly improves the plant's material and people flow as well as enhances the HVAC capacity for greater control of the plant environment. To support sterile product release for material to be supplied in the European Union, the company has also added two Skan ARIS isolators equipped with integrated vaporised hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington, North Carolina.
AAIPharma expects both facilities to be fully validated and EU approval granted for the Charleston facility in the second quarter of 2007.
“Although the facility is already fully US FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA in the UK,” said Lee Karras, AAIPharma senior vice president of North American pharmaceutical operations. “This is of particular importance to customers who wish to conduct clinical trials in the EU as well as export marketed product to Europe.”
