PAT SUPPLEMENT


the characteristics of the method and can be a potential opportunity for innovation.


“Interfacing of measurement techniques with pharmaceutical manufacturing equipment is often where most technical problems are encountered. Are vendors aware of the implications of failure to deal with these issues adequately, and what active steps are being considered to help their customers in this important area?”


Frédéric Despagne: In process analytics, proper sampling is often the main success criterion. Preliminary technical information exchange with end-users represent a significant part of project definition phase. When third- party sampling accessories are needed, we deal with a limited number of properly qualified suppliers. There are procedures in place to pre-test and document accessories at factory. We also draw customers’ attention to the importance of preventive maintenance that is sometimes less considered in the pharma - ceutical than in the petrochemicals industry. Our Quality and Service departments established protocols to follow-up and document failures that may occur. For that aspect, standards were clearly set by our aerospace and pharmaceutical activities.


John Richmond: Many challenges do arise when a PAT analyser is interfaced to a piece of manufacturing equipment. Bruker has a consultative approach whereby we will understand the issue, investigate the problem and work with a team of technical specialists either in-house or outsourced to design and manufacture a technical solution that will be fit for purpose. Bruker has had many years experience in this area, successfully interfacing to fluid bed dryers, high shear mixers, bin blenders, compression and encapsulation machines. You need to have the expertise, knowledge and experience to understand processes such as powder flow or flow characteristics of a vessel to enable you to make a valid judgement as to the best design for a particular interface.


Mario Becker: Interfacing needs be disting - uished between mechanical and data interfacing. Regarding mechanical adaption of


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probes or bypass loops properties like minimised or eliminated dead volumes, cleaning and sterilisation options as well as the use of standard ports are the key success factors. Data integration as another critical area is first the data acquisition of the generated analytical data, subsequent data evaluation (e.g. by statistical or chemometrics means) and the interfacing to PLC, MES or ERP systems. Providing pharmaceutical manufacturing equipment, process analytics and sensors as well as SCADA systems, Sartorius offers synchronised and pre- configured solutions that can easily be adapted to existing infrastructures.


James Brenner: Due to the flexible nature of a mass spectrometer and our involvement in many different markets and applications, Extrel has experienced nearly 50 years of providing unique analytical solutions for a variety of different processes. We pride ourselves in our ability to engineer, develop and support customer specific interfaces that many larger companies would not address. For example, a recent development in our inlet technology now allows us to sample a dynamic pressure range from +760 torr down to 2 torr, an excellent solution for pharmaceutical drying vessels. We welcome the challenges set forth by our customers in hopes of driving our understanding to new levels.


“Customers in the pharmaceutical industry may be reluctant to adopt a technology which is unfamiliar to regulators due to the increased risk of a delayed or unsuccessful approval of the proposed medicinal product. How are vendors actively promoting and explaining their technologies to worldwide Regulatory Agencies?”


John Richmond: Education of the Regulatory Authorities with respect to technology is an area that Bruker is very active in. We regularly participate at international conferences such as QbD/PAT conference in Heidelberg or the IFPAC meetings in the USA and Puerto Rico. This gives us an opportunity to present our latest studies and implementations to audiences that normally include regulators. We have also worked closely with organisations such as the ASTM through the E55 committee and the PQRI.


In addition, we work directly with key early adaptors in the pharmaceutical industry and support their efforts to get regulatory approval.


Mario Becker: Sartorius and its experts are engaged in different industrial organisations like ISPE, GAMP or PDA to gain and shape current thinking and contribute to new or revised guidelines. We also approach regulatory bodies to discuss current issues, technological challenges and get interpretation guidance. As Sartorius is applying and adopting technology solutions to customer and process needs, we are also actively cooperating with partners to demonstrate our solutions and applications on international conferences in Asia, America and Europe, to share and reflect progress and innovations with the industrial community.


James Brenner: Mass spectrometers are already a widely accepted technology; recognised by regulators for its specificity / selectivity and sensitivity. Along with our process mass spectrometers, Extrel provides research mass spectrometers and components to numerous government agencies across the globe. This gives Extrel a unique opportunity to discuss our products and techniques within the regulatory communities themselves. We also continually present papers at international events and tradeshows such as IFPAC and PITTCON, in which we detail the advantages and uses of mass spectrometers in the pharmaceutical industry.


Frédéric Despagne: We participate in workgroups with some regulatory bodies. However, NIR has been one of the most documented techniques in guidelines; its breadth of applicability is becoming recognised in the industry. We see more need for training in the biopharmaceutical industry where PAT/QbD concepts were more recently introduced. FDA’s Office of Biotechnology Products highlighted the need for collaboration with industry and vendors to assist with PAT implementation. We have a partnership with the Biomanufacturing Training and Education Center (North Carolina) which is equipped with some of our process equipments including analysers, control systems and data management tools. One of its mandates is to train the industry professionals and FDA inspectors on use of process analytics for biomanufacturing.


European Pharmaceutical Review 17 Volume 16 | Issue 6 | 2011


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