SYDNEY, Australia, Aug. 31 /PRNewswire/ -- Sanbe Farma has grown to be Indonesia’s largest ethical pharmaceutical manufacturer. Their medicinal products include over 150 different preparations ranging from antibiotics to vitamins. Currently Sanbe Farma is focused on the local Indonesian market but plans to commence exporting from their new sterile facility in Cimareme, which is located in Bandung, a regional center on the island of Java.
(Photo: http://www.newscom.com/cgi-bin/prnh/20050831/SFW065 )
Sanbe’s brief was for an international quality facility meeting (PICs) standards for Large and Small volume Injectables. Now in its final validation stages the Cimareme facility has been inspected by international experts and has been declared as "...one of the best plants we have ever seen.” It certainly sets a new standard for the manufacture of sterile eye preparations and injectable drugs in the Asia region and gives Sanbe an opportunity to export to western countries as well as satisfy a growing local market.
Kinetics biopharm has lead the design and construction of the new facility, utilizing its resources from around Asia to provide a cost effective and international quality program. Kinetics biopharm head office in Sydney completed the designs for the Large Volume Parenteral (LVP) and Small Volume Parenteral (SVP) manufacturing Suites. They also designed the clean and general utilities and provided the automation and controls for the complete facility. Kinetics’ Melbourne fabrication facility manufactured the LVP and SVP process modules and piping detailing were completed in Kinetics’ Shanghai office. Sanbe installed the modules and Kinetics’ Singapore completed the high purity piping installation, including over 4000m of SS316L EP tube. Kinetics Sydney Engineers commissioned and tested the control systems to confirm compliance with GAMP4 and USFDA CFR21 part 11 requirements.
One of the features of the Cimareme plant is the very high standard of Automation. Three separate GAMP4 SCADA/PLC systems provide supervision of the Utilities and Process Systems. The LVP system has been designed for high throughputs and is fully automated. The SVP system operates semi automatically and was designed to provide a high level of flexibility to manufacture a wide range of products. Kinetics designed and managed the control system implementation and supervised the final site acceptance testing.
The new Sanbe Cimareme facility sets a new benchmark for injectable drug manufacture in Asia. It is also a clear demonstration of the ideals of Kinetics Asia biopharm strategy of providing cost effective international standard pharmaceutical facilities.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20050831/SFW065AP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comKinetic Systems, Inc.
CONTACT: Michael Lynch, Senior Vice President, Sales & Marketing,mlynch@kineticsgroup.com, or Peter Horn, Operations Director, Australia,Vice President, biopharm, phorn@kineticsgroup.com, both of Kineticsbiopharm
Web site: http://www.kineticsgroup.com/
