Applying our process and biocontainment know-how, NNE designed a multipurpose facility that enabled Hisun to produce a range of sterile and nonsterile dosage forms under cGMP and high-containment conditions.
Chinese company Hisun decided to build a new production facility for sterile and nonsterile dosage forms under high-containment conditions. The facility had to be fully cGMP-compliant and be able to produce a range of products.
Hisun chose an international team from NNE to execute the project. The joint Indian and German team worked on the facility, from conceptual design up to extended basic design. The scope also included a GMP check of detail design, periodic site supervision to check cleanroom finishes, and validation documentation support.
International compliance and salient features
The project covers an area of 80,000 m2 on a 100,000 m2 plot, and is engineered to meet cGMP requirements from a range of regulatory authorities including the FDA in the US, MHRA in the UK, Europe’s EMEA, and the Chinese CFDA. It was essential for Hisun that the facility had salient technological features, such as high-containment barrier isolation technology using isolators and cRABs; and especially designed double door lyophilizers with vertical configuration.
A variety of product groups
With extensive knowledge of process areas and the high-containment sector, the NNE team was able to design a facility that met Hisun’s need for a range of product groups. The facility allows Hisun to produce an array of products: from cytotoxic formulations (injectables and OSD), non-cytotoxic OSD, PENEMS (sterile bulk and formulations) and anti-tuberculosis drugs (injectable formulations).
Sep. 2005 – end 2009
USD 100 million
Conceptual design, extended basic design, GMP check of detailed design, periodic site supervision related to GMP compliance, validation and documentation support