Jointly hosted by the pharmaceutical microbiology society Pharmig and the pharmacy experts and distributors Sanolaor, the theme of the conference was around best practices in sterile products manufacture and microbiology. The conference was run in both Zagreb (Croatia) and Ljubljana (Slovenia) on March 27 and 28, 2019.
The conference was hosted by David Keen, chair of Pharmig and a senior global microbiology consultant with the healthcare company Ecolab. The first presentation was delivered by Tim Sandle, focusing on the forthcoming changes to sterile products manufacturing guidance as contained in Annex 1 of the European Union Good Manufacturing Practice (GMP) guidance. The broad themes of the revisions were discussed, including the importance of a keeping up-to-date with new technology and processes (such as using barrier systems to separate human operators from medicines during manufacture) and the use of rapid microbiological method. The presentation also considered the importance of a holistic contamination control strategy, stretching from the purchase of raw materials through to the distribution of the finished medicinal products – a strategy that needs to be informed by risk assessment.
The second presentation was about cleaning and disinfection, delivered by David Keen. The presentation considered new scientific thinking on residues from disinfection agents and the possible risks that residues have on future cycles of disinfection or to the efficacy of microbial recovery, when agar plates and swabs are used to assess the efficacy of cleanrooms. Keen described the different chemical tests that can be deployed for the assessment of residues on cleanroom surfaces.
Tim Sandle delivered the third lecture, looking at a isolator technology as used for the sterility test. Isoaltors are enclosed spaces, physically separated from the external environment which are supplied through HEPA (high efficiency particulate air) filters and subject to automated disinfection. The use of isolators reduces the risk of ‘false positives’, meaning that only genuinely contamination sterile products will be flagged. This is dependent, however, on correctly validated and well-maintained barrier systems. Sandle described the different types of bio-decontamination technology used to sanitize isolators – using hydrogen peroxide vapor – and the methods of microbial kill (free radical reactions). The key cycle parameters to ensure that isolators operate efficiently were also highlighted.
The conference then broke into two streams. Delegates on the pharmacy side attended a sequence of session run by Tim Sizer, who is a regional pharmaceutical quality assurance office with the U.K. National Health Service. Sizer took delegates through monitoring requirements, clean spaces and aseptic preparation principles.
In other stream, delegates from the pharmaceutical sector attended a presentation from Paige Shelley, a microbiology senior analyst from the company Wockhardt, about cleanroom design and function. Cleanrooms provide ‘clean’ spaces for medicinal manufacturer by being supplied with specially filtered air; through the air moving to remove contaminants; and ensuring that rooms of a cleaner specification are at a higher pressure differential to lower specified rooms. The presentation was rich in case studies, presenting scenarios relating to the key things to consider when operating cleanrooms and what to do when cleanrooms go wrong.
This was followed by a presentation from David Keen on selecting the optimal microbial identification system, considering those that assess the microbial phenotype and those systems which look at genetic characteristics. Keen discussed manual, semi-automated and automated technologies, the latter two groups of technologies which use digital capture and compare collected data against databases.
The final presentation of the plenary was delivered by Paige Shelley, which considered the types of water found in pharmaceutical systems and the relative levels of microbial bioburden expected together with consideration of microbial by-products like bacterial endotoxin (which can trigger a pyrogenic response should sufficient endotoxin enter the mammalian bloodstream). Shelley extended her presentation to include testing requirements and she provided a case study to the delegates.
The final phase of the conference brought both streams back together for a workshop conducted by Tim Sandle on the best practices for conducting an environmental monitoring risk assessment, which captured the main themes of the day centered around risk assessment and how robust monitoring with a scientific rationale is a necessary part of the contamination control strategy.
The overall objective of the two conferences was to ensure that safe and efficacious sterile medicinal products are manufactured.
