In 2005, Chinese company Hisun decided to build a new production facility for sterile and non-sterile 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 Pharmaplan 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 clean room finishes, and validation documentation support.
International compliance and salient features
The project covers an area of 80,000 sq.m. on a 100,000 sq.m. 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 SFDA.
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 lyophilisers with vertical configuration.
A variety of product groups
With extensive knowledge of process areas and the high-containment sector, the NNE Pharmaplan team was able to design a facility that met Hisun’s need for a range of product groups. Currently in the execution phase, the facility will allow Hisun to produce an array of products: from cytotoxic formulations (injectables & OSD), non-cytotoxic OSD, PENEMS (sterile bulk & formulations) and anti-tuberculosis drugs (injectable formulations).