The facility includes an automation layer for process sequencing, automated transport systems and a manufacturing execution system (MES) layer for electronic batch records (EBR) and data archiving.
Transporting of goods and materials is carried out automatically by Automated (laser-) Guided Vehicles without any operator control. The batch data are collected automatically into the MES. Raw material NIR identification and evaluation, online NIR blend monitoring, online NIR core testing and NIR testing of film coated tablets are in place to support the vision of adaptive process control and/or to replace conventional release testing.
Looking back it’s apparent that Pfizer knew they had an award winning facility on their hands.
By just reviewing the information they provided in their submission material you get a sense of the pride and accomplishment that they have in their new facility.
The judges have conferred and cast their ballots - Pfizer’s NEWCON (New Containment Facility for Oral Solid Dosage) facility in Illertissen, Germany has been named the 2008 Facility of the Year award winner.
The annual Facility of the Year Awards (FOYA) competition, sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, and Pharmaceutical Processing magazine is designed to recognize and reward the facilities and people behind the industry’s most advanced manufacturing plants.
The plant currently uses a production area of 1,600 m2 and has a production capacity of 1 billion tablets per year.“What we have accomplished in terms of automation, process integration and process analytical technology (PAT) is groundbreaking - these are the features that really stand out,” says Holger Weyhers, Head of Production.He also points out that all unit operations at the Illertissen facility are within a single containment module, supported by automated systems without any manual handling.Upon completion, the US .8 million (US million with soft costs), single floor, single containment module facility features a total production floor area of 7,800 m2 that consists of 3,000 m2 of production space, including the currently idle areas for potential expansion.Construction ended in September 2007 and production began in October 2007, when the German inspection license (PIC) was granted to the facility.NIR water content is filed; filing of online NIR core testing is foreseen. Safety No operator attendance is required, substantially enhancing health and safety aspects for the employees.When the Pfizer team first conceptualized the NEWCON facility in April 2004, the main, practical purpose was to create a manufacturing plant for oral solid dosage forms including high potency compounds with a high degree of integrated automation to produce the smoking cessation drug varenicline (Chantix®, Champix®).