Newsletter_12-2022_EN

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www.reinraum.de NEWSLETTER www.cleanroom-online.com Edition EN 12-2022 | Page 2/42 concepts. The topic of sustainability was addressed in presentations such as „Delivering energy efficiency solutions in pharmaceutical and life science cleanrooms“ by Keith Beattie (EECO2), „Towards holistic sustainability through circular economy“ by Prof. Dr. Julia Krause (HTW Dresden) and „Sustainability and Contamination Control in Hospitals“ by MSc. Remko Noor (Maximuse B. V.). In the lecture „Personalized Medicine – Chances and Challenges“, Morten Schlothauer also spoke about the relevance of patient-specific drug manufacturing. In addition, lectures on intralogistics, diversity and the promotion of young talent in the cleanroom sector also proved to be a magnet. A total of 22 renowned experts shared their know-how with Cleanzone participants and facilitated exchange on current challenges. The number of exhibitors also increased for the anniversary edition. 82 exhibitors from 17 countries exhibited at Cleanzone. A total of 1.500 participants from 38 countries visited the trade fair (2019: 1,300 participants from 42 countries). Besides Germany, the most important visitor countries were the Netherlands, Türkiye, Switzerland, Ireland, France, Great Britain, Italy, Austria, the Czech Republic and Sweden. The degree of internationality of the visitors reached about 30 per cent. Most of the trade visitors came from the pharmaceutical industry, microelectronics and biotechnology. Cleanzone will be held every two years in future. The next edition will take place on 25 and 26 September 2024 in Frankfurt am Main. And the Cleanzone Award goes to… Out of eleven applications submitted, five prevailed for the Cleanzone Award 2022 and were ultimately nominated for the prize by the expert jury. In the end, the Cleanzone Award 2022 was awarded to Reinraum- Mieten with the innovation “Cleanroom Rental”. The project provides temporary, individually configurable cleanrooms and in the end convinced the jury and the trade fair audience. Reinraum-Mieten receives an award and 3,000 euros for its innovation from Wiley publishing house, Cleanzone partner. cleanzone Messe Frankfurt Exhibition GmbH Ludwig-Erhard-Anlage 1 D 60327 Frankfurt am Main Telefon: +49 69 7575 6290 Telefax: +49 69 7575 96290 eMail: anja.diete@messefrankfurt.com Internet: https://cleanzone.messefrankfurt.com DECEMBER 2022 Dear cleanroom professionals, A few interesting and informative days lie behind us. We were exhibitors at Cleanzone, which celebrated its 10th anniversary this year. To sum up for all those who were not there and for all quick readers: our highlight was not the yellow Aston Martin on our stand, but the new directory of REINRAUM EXPERTEN. On 240 pages we now offer a clear compilation to all those who are looking for REINRAUM EXPERTEN. You can read more about this on the following pages. If you are looking for an EXPERT but have not been to Cleanzone, you can easily request the EXPERT directory by eMail. We will send it with invoice for a flat rate of 10 Euro (DE)/ 15 Euro (INT) including packaging and shipping by post. eMail to: info@reinraum.de. Scan or kick to the movie In the meantime you can read the new newsletter with current information. > Ten years of Cleanzone: Fulminant restart for the anniversary edition in 2022 > Overall impact of new Annex 1 in pharmaceutical industry > Sensational and innovative as ever > Reliable and sustainable process for cleaning high-tech components in cleanrooms > Advanced Bio-decontamination with Vaporized Hydrogen Peroxide > Standards are here to stay > Clean Communication: SEMI Standards > . . . I wish you interesting reading. With kind regards Reinhold Schuster
www.reinraum.de NEWSLETTER www.cleanroom-online.com Edition EN 12-2022 | Page 3/42 Overall impact of new Annex 1 in pharmaceutical industry Annex 1 and sterilization process: an interview with Tim Sandle The revision of Annex 1 is requiring a major effort from the life sciences industry; from ‘setting up new processes, to training staff, to managing noncompliance, the industry needs to adapt particularly to new requirements regarding contamination control strategy and the essential elements needed to develop a robust sterility assurance system. One of the most discussed processes involves autoclaving and the risks associated with it. We talked about it with Tim Sandle, a microbiologist, author and science journalist, known as one of the leading experts in the field. Our interview opens with an assessment of the overall impact of the new Annex 1 on contamination control strategies in the pharmaceutical industry. Dr. Tim Sandle, the new Annex 1 revision is distinguished by a “holistic” view of contamination control. What are the most immediate consequences of this new approach? Many facilities have developed approaches to contamination control, but the call within the Annex is for pulling everything together to provide a holistic overview of the facility, the rationale, the gaps, the level of risk for each gap, and the remediation steps. A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (the detectability of contamination event). As a governing ethos, processes, equipment, facilities and manufacturing activities should be managed in accordance with risk management principles that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality. The strategy at each facility will vary, but common themes will include: microbial contamination, cleaning and disinfection, sterility assurance, facility design, chemical and particle contamination. Outside of the microbial, other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations. Overall, a focus will need to be with reducing contamination likelihood and cross-contamination potentials. This needs science and technical procedures and controls. The format would be as one document or series of connected documents developed to reflect the site-wide strategy for minimizing contamination control. Importantly, the strategy should be a living document and be updated in relation to change controls, process development, recurrent deviations and in relation to other quality records. Challenges in sterilization processes What are the challenges facing the pharmaceutical industry in sterilization processes with respect to the requirements of the new Annex1? Perhaps the most significant change is in relation to equipment sterilization when used for aseptic processing. The 2017 draft stated that critical surfaces with direct impact need to be sterilized (such as a filling manifold or stopper bowl); however, with the 2020 revision this now requires direct and indirect contact parts to be sterilized. This could present challenges to facilities with both isolators and RABS devices. There is a specific update for freeze-dried products in terms of freeze-dryers (or lyophilizers). This is for lyophilizers which are manually loaded or manually unloaded. Here the freeze-dryers should be sterilized before each load. Other important Annex 1 points include the requirement that the feed water to a pure steam (clean steam) generator should be appropriately purified, to achieve the required chemical and endotoxin levels, as assessed by the Water-for-Injections pharmacopeial monitoring and testing requirements. With the chemical requirement, this is because steam used as a direct sterilizing agent must not contain additives at a level which could cause contamination of product or equipment. This part of the process needs to be validated. The steam must also consistently meet the parameters for non-condensable gases, dryness value (dryness fraction) and superheat. The Annex also specifies that each item sterilized needs be inspected for damage, packaging material integrity and moisture on removal from the autoclave. Any item found not to be fit for purpose, either damaged or where there is evidence of a ‘wet load’, should be removed from the manufacturing area and an investigation performed.
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