At FarmaForum Telstar addresses the new contamination control strategy governed by Annex 1 for the manufacture of sterile drugs, with both sessions taking place consecutively on the 3 of November from 10am
Left: Ana Franco, Commissioning & Qualification Team Leader at Telstar; Right: Jordi Serrat, Product & Technology Director at Azbil Telstar
Telstar will be taking part at FarmaForum 2021 (Madrid, 3-4 November 2021), the congress for the pharmaceutical, biotechnological, cosmetic and laboratory technology industries. Within the framework of this event, Ana Franco, Commissioning & Qualification Team Leader at Telstar, will be chairing a workshop titled “Contamination Control Strategy (CSS)”, where she will discuss and advise on how to implement the new strategy as a control & prevention mechanism in accordance with requirements governing European GMPs.
The development of a Contamination Control Strategy is one of the new requirements included in the draft of the new EU GMP Annex 1 for the manufacture of sterile medicinal products. Sterile product manufacturing laboratories should adapt their processes and installations to the new specifications. The purpose of the new measure is to avoid potential product contamination through a more detailed control plan and implementation of a risk management process in all phases involved in sterile manufacturing.
The new contamination management strategy embraces a broad spectrum of actions aimed at the pharmaceutical industry including the prevention and contamination control as a global view at all stages of production, from installation design, equipment and services, staff selection process, raw materials, development of maintenance and cleaning operations, etc. The CSS enables the identification of potential causes of contamination and thus the implementation of the appropriate control measures to avoid it using a correct strategy.
Although all pharmaceutical companies have some contamination control plans available, the new regulation sets out mandatory common requirements which will be addressed at FarmaForum, in addition of the necessary resources and tools aimed to implement this strategy by the most effective way.
Jordi Serrat, Corporate director of Technology at Telstar, will unveil the latest trends in intelligent predictive maintenance and digitisation applied to complex equipment and production processes for the pharmaceutical industry, in addition of the new paradigms in the field of digital transformation and the Internet of things (IoT) of the GMP 4.0 industry.
Under the heading of Pharma 4.0 IoT Data Platform for predictive maintenance, this session will address the impact of the data generated by the operations of a production line once collected and processed through an Internet of Things (IoT) platform on the improvement to the availability of assets. Once processed using analytical and big data tools, the data is compared with assets of the same type in similar production situations. This ability to generate and, at the same time, manage comparative indicators allows the industry to improve OEE (Overall Equipment Effectiveness) and move towards predictive maintenance.
The speaker will analyse the pros and cons of different models (proprietary model versus specialised partner “shared” model) as well as the platform ownership versus the SaaS model, in addition to delving into how to calculate the ROI for a 4.0 pharmaceutical investment (direct and indirect ROI).
Ana Franco, Commissioning & Qualification Team Leader at Telstar, has a degree in Biology from the University of Salamanca. With more than 20 years of experience in the pharmaceutical sector, she is specialised in Quality Control and Quality Assurance. During the last 15 years Ana has been developing her professional activity in the Telstar Consultancy area as an expert in conceptual design of new production plants and qualification of facilities, equipment, and services for the pharmaceutical and biotechnology industry.
Jordi Serrat, Product & Technology Director at Azbil Telstar (Telstar), holds an electrical engineering degree from the University of Industrial, Aerospace and Audiovisual Engineering of Terrassa (ESEIAAT). He also has a Master degree in Functional Areas Management from the Chamber of Commerce and Industry of Terrassa and a Master degree in Project Management for directors from IESE Business School. In his current position, he is in charge of R&D and industrialisation of new developments, focusing on new digital technologies to develop added value services associated to the Telstar portfolio. Previously, he has developed his professional activity as Technology Manager, performing functions of Engineering and R&D Management at Telstar; General Manager of the joint venture IMA- TELSTAR SL for Freeze Drying Equipment for the Pharmaceutical Industry, and Head of Engineering and Manufacturing of Special Projects in Telstar Industrial SL.
Telstar will also be present at FarmaForum 2021 as an exhibitor (Stand D48 – C49). Telstar is a leading global brand of aseptic process solutions. The company, part of the azbil Group, specialises in the development of engineering & construction projects, integrated process equipment and GMP consultancy solutions, including turnkey projects and critical installations, for companies associated with Life & Health Sciences (pharmaceutical & biotechnology, healthcare, cosmetic, veterinary, and food & beverage industries, hospitals, laboratories & research centres).