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AAIPharma Grows and Strengthens Parenteral Manufacturing and Sterile Product Release Capabilities.


WILMINGTON, N.C. -- AAIPharma Inc. announced today the completion of over $2.0 million in upgrades to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina For other places with the same name, see Wilmington (disambiguation).
Wilmington is a city in New Hanover County, North Carolina, United States. The population was estimated at 100,000 as of 2006;[1]
. 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.

According to Lee Karras, AAIPharma senior vice president of North American pharmaceutical operations, "By making this investment, we have made a commitment to existing and future customers that parenteral manufacturing is important to AAIPharma. Although the facility is already fully US-FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA MHRA Medicines and Healthcare Products Regulatory Agency
MHRA Modern Humanities Research Association (United Kingdom)
MHRA Minnesota Human Rights Act
MHRA Malta Hotels and Restaurants Association
 in the UK. This is of particular importance to customers who wish to conduct clinical trials in the EU as well as export marketed product to the EU. In addition, this complements our formulation and biotech analytical development businesses where we expect to see continued growth."

The upgrade in the Charleston facility significantly improves the plant's material and people flow as well as enhances the HVAC (Heating Ventilation Air Conditioning) In the home or small office with a handful of computers, HVAC is more for human comfort than the machines. In large datacenters, a humidity-free room with a steady, cool temperature is essential for the trouble-free  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 AG ARIS ARIS American Religious Identification Survey
ARIS Architecture of Integrated Information Systems
ARIS Active Rack Isolation System
ARIS Aggregate Route-based IP Switching
ARIS Agentia Romana pentru Investitii Straine
 Isolators equipped with integrated vaporized va·por·ize  
tr. & intr.v. va·por·ized, va·por·iz·ing, va·por·iz·es
To convert or be converted into vapor.



va
 hydrogen peroxide decontamination decontamination /de·con·tam·i·na·tion/ (de?kon-tam-i-na´shun) the freeing of a person or object of some contaminating substance, e.g., war gas, radioactive material, etc.

de·con·tam·i·na·tion
n.
 technology to its microbiology laboratory in Wilmington, North Carolina.

"These facility enhancements are part of AAIPharma's strategic commitment to process improvement and innovation," said Ludo ludo
Noun

Brit & Austral a simple board game in which players move counters forward by throwing dice [Latin: I play]

Noun 1.
 Reynders, Ph.D., AAIPharma president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are continuing to make significant investments in capabilities and technologies aimed toward the evolving needs of our global customer base."

AAIPharma expects both facilities to be fully validated and granted EU approval for the Charleston facility in the second quarter of 2007. With these improvements in place, AAIPharma has become one of few service providers with the ability to move parenteral and biotech products from early pharmaceutical development and manufacturing into full global clinical development.

About AAIPharma

AAIPharma Inc. is a global provider of product development and support services to the pharmaceutical, biotechnology and medical device industries. From a single test through a range of integrated service offerings, we create value to an industry in search of productivity and innovation. For more information on the Company, please visit AAIPharma's website at www.aaipharma.com.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 3, 2007
Words:398
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