2015 Facility of the Year Awards Category Winners
Category Winner for Equipment Innovation
Astellas Pharma, Inc
Tube Labeling Project
The ability to supply a diverse global supply chain was the central theme in Astellas Ireland Co Ltd. (Kerry) Tube Labeling project. The selection of this project as winner of the Equipment Innovation category was for their tube packaging and labeling equipment innovation.
Astellas (Kerry) supplies worldwide distribution of filled ointment tubes in 72 presentations (3 sizes, 2 strengths and 26 areas in Europe alone). The plant imported unique, country specific pre-printed packaging and bulk tube products, fills and packs them into cartons and ships to European countries. This supply chain required significant raw material stores, long lead time, significant QC acceptance testing, complex changeovers and is subject to multiple sales and regulatory organization oversight.
Astellas delivered a technology innovation allowing it to fill product into common tubes which are printed with only common information for various markets, and introduced a process to add country specific label information on common tubes. The team completed development of a new tube packaging design that successfully accepts applied labels on filled tubes, which met stability and customer requirements, while meeting regulatory affairs and sales affiliate requirements of each country in Europe. Astellas, with Harro Höfliger, succeeded after significant development trials, in producing a unique packaging equipment design which applied soft transparent labels on the entire surface of both sides of pre-filled laminated tubes. They overcame significant technical challenges of applying labels to both sides of a filled tube while insuring seal integrity and correct label positioning accuracy with no bubbles or wrinkles. The system incorporated a full automation system, including carrier tube handling with RFID system, barcode checking and camera inspection system to insure overall package quality.
This innovation dramatically improved plant flexibility, simplified the supply chain (reduced presentations from 72 to 6), significantly reduced acceptance testing, product raw materials stock levels (from 6 months to 3) and overall delivery lead time. Product description on a tube is now informed to patients more quickly, including artwork changes and new products launches (by approximately 6 months).
These innovations led to the selection of this project for the winner of the Equipment Innovation award. This is an example of a project team challenging the standard and making imaginative and effective use of equipment innovation as a way to improve the way products are efficiently packaged and supplied to global markets.
Category Winner for Project Execution
Farmers’ Fields to Pharmaceuticals
AstraZeneca China won the Project Execution category for their market supply solid dose facility located in Taizhou, China. This project, consisting of over 533,000 sq. ft. of total site development represents Phase I of a planned three phase, greenfield site development in the new pharmaceutical center city of Taizhou, China. Constructed in the record time of 20 months (ground-breaking to OQ lots complete) at a total project cost of $170M, this facility is capable of producing 5B tablets in a fully integrated solid dosage site including formulation, tableting, labeling, packing and distribution operations. These operations further position AstraZeneca China, already one of the largest in-country pharmaceutical manufacturers in China to further serve, with cost effective medicines, China’s growing regional markets.
AstraZeneca China’s in-country team used a broad range of AstraZeneca China’s global engineering, operations and safety practices to complete this facility on time, and 18% under sanctioned budget while maintaining an exemplary safety record. This facility was one of the earliest large pharmaceutical facilities developed in partnership with the CFDA and local authorities, to establish the third tier city of Taizhou as a new pharmaceutical hub. Programs including a fully integrated project execution team (One Team/One Goal) including all key internal and external stakeholders, and a Plan-to-Do Review (PDR) process helped drive this project to success.
A few examples of the successes achieved on this project include best in class safety performance with 3.26M man hours worked without a recordable safety incident. Construction safety was driven from the outset in a top to bottom engagement of senior management through field workers program involving training, incentives and constant oversight and audit. Safety reporting was audited on an ongoing basis by AstraZeneca China corporate and in-country Global Engineering specialists to ensure reporting compliance and response to leading safety indicators.
Hiring and training focused upon developing locally available employees as part of AstraZeneca China’s “Farmers to Pharmaceuticals” aspiration for this project. 89% of final staff was hired and trained locally. Training included the use of early mockup training areas and temporary assignments to other AstraZeneca China facilities. Attrition rates to this day remain low: 6% vs. much higher rates routinely experienced in China.
To achieve cost targets, while maintaining AstraZeneca China’s required global operating quality standards, AstraZeneca China focused significant effort on in-country sourcing. 32 of 37 major equipment packages, and numerous key building components such as clean room wall systems, were successfully sourced in-country. Quality was maintained through an aggressive program of vendor support, including in-factory engineering monitoring and training.
Category Winner for Facility Integration
Multipurpose Biologics and Vaccines Production Facility (Isolator Vaccine Filling Unit)
IDT Biologika is an innovative privately‐held company with more than 90 years of experience in research, development, manufacture and distribution of biologics for the global protection of human and animal health. A major manufacturer of human vaccines designed to address some of the world’s most dangerous infectious diseases; IDT Biologika completed and certified the construction of a large‐scale production facility dedicated to filling and lyophilization of biologics and vaccine products. The €40.5MM Multipurpose Biologics and Vaccines Production Facility, incorporating a €12MM isolator for vaccine filling, expands IDT Biologika’s site in Dessau, Germany.
The facility has been designed and commissioned for use in a range of advanced biomedical technologies required in medium to large clinical stage and commercial stage volumes. Included is a sterile liquid filling line engineered to handle up to 24,000 vials per hour within a 1,600m2 cleanroom area. This facility is certified to biosafety levels (BSL) 1 and 2 for live vaccines. Inspected for GMP certification in July 2014, qualified (for IQ, QQ and PQ) in September 2014 and authorized for manufacturing in October 2014, the facility is now fully operational.
The highly automated manufacturing facility for filling and freeze‐drying is designed to be modular, efficient and expandable. The purposed concept behind the multipurpose facility consists of strict horizontal division of the service areas. The production area is located at the building’s center with a maintenance level and air conditioning systems located above and the media supply for the productions area below. The layout was devised to guarantee the shortest supply and disposal routes. Design of the integrated equipment suite represents significant contributions in operational excellence, including 3 isolator segments for high flexibility and fast product changes, resulting in efficient product change over and increased efficiency. Key to the efficiency of the new facility is a fully automated loading and unloading freezedryer at shelf capacity of 40m2 each, equal to at maximum 178,000 vials per batch that is fully integrated into the isolator.
Pharmalucence, a Sun Pharma Company
Aseptic Fill-Finish Facility
Pharmalucence, a Sun Pharma Company receives honorable mention for their execution and the entrepreneurial spirit demonstrated by the construction of their new aseptic filling facility in Billerica, Massachusetts.
Pharmalucence aseptically fills and finishes a portfolio of legacy and generic radio-pharmaceutical products, many of which are in market shortage. Their existing operations, housed in four separate rental facilities, were in critical need of modernization to address operational inefficiencies and dated facilities. They recognized that a significant change was needed to ensure the long term availability of their product supply and the viability of their business. Given limited financial resources their challenge was to effectively plan, prioritize and implement the upgrades needed for full regulatory compliance and product supply integrity all within a competitive business model.
Pharmalucence partnered with a full service engineering company, to develop a strategic business model and execution plan. Weighing options, they took the bold financial and technical step to consolidate their four existing operations into a single modern facility. They identified an existing facility large enough for their objectives and near enough to retain existing staff. Utilizing QbD principles they started the facility design with the project deliverables well defined in order to minimize costly delays and changes. RABS and isolators were fully compared and for their particular aseptic processing needs isolators proved the most cost effective solution.
Their project implementation plan took into account their existing lease obligations, product supply obligations and construction timelines. New areas were prepared and equipment transferred to correspond with the expiration of leases for economic efficiency. The completed facility is fitted with high quality finishes and an installed equipment base consistent with industry best practices. Their uses of risked based CQV help ensure a quick and effective operational start up.