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article imageMicrobiologists meet to make pharmaceutical manufacturing safer Special

By Tim Sandle     Feb 14, 2019 in Science
Birmingham - Microbiologist met recently in the U.K. to discuss best practices for monitoring cleanroom environments (the space within which pharmaceutical medicines are produced). The theme of the event was on risk-assessment.
The meeting of microbiologists from the U.K. and Ireland was hosted by Pharmig, the professional association for microbiologists working in the pharmaceutical sector and allied industries. The meeting took place at the Nailcote hotel and country club, located on the outskirts of Birmingham.
Nailcote Hall is a four-star 17th century country house hotel located in Berkswell  Warwickshire  Un...
Nailcote Hall is a four-star 17th century country house hotel located in Berkswell, Warwickshire, United Kingdom. The hotel features 49 rooms alongside a Par 3 Champion golf course, restaurant, and leisure and conference facilities. The venue also hosts weddings and entertainment events.
Environmental monitoring concerns the assessment of the space within which pharmaceutical processing takes place. This relies upon long-standing monitoring methods, such as active air-samplers (which draw a fixed volumetric quantity of air across microbiological culture media); settle plates, to determine how many microbial carrying particles may be deposited in acritical area through gravitational settling; samples of surfaces; and assessments of airborne particles using optical instrumentation. These so-called classic methods have been supported by some rapid microbiological methods, based on more advanced technologies, such a spectrophotometric techniques and which form part of the digital transformation of pharmaceutical microbiology.
A man at an exhibition stand at the Pharmig event.
A man at an exhibition stand at the Pharmig event.
Such samples only add value if they are taken in meaningful locations (which means understanding the process) and where the data is correctly analysed, using processes that also secure the data and ensure it is integral. These risk-based themes featured heavily throughout the day.
The day began with a presentation delivered by Edel Fitzmaurice on the basis of the environmental monitoring program, including the key elements to include and some of the concerns with programs expressed by regulators.
Edel Fitzmaurice presenting at the Pharmig conference.
Edel Fitzmaurice presenting at the Pharmig conference.
This was followed by a presentation from Tim Sandle that looked at the concept of risk; the main types of hazards affecting cleanroom environments; and three case studies of how risk assessment can be applied. The case studies looked at Hazard Analysis Critical Control Points (HACCP) for selecting locations; risk filtering, for setting monitoring frequencies; and Failure Modes and Effects Analysis (FMEA) to assess processing equipment.
Tim Sandle presenting at the Pharmig environmental monitoring conference.
Tim Sandle presenting at the Pharmig environmental monitoring conference.
Sandle gave a second presentation on incubation strategies and culture media selection, linking these choices to the Human Microbiome Project. This was followed by a presentation from Anna Lovatt about the approach to microbial identification and the different technologies that are available to assess microorganisms.
Conference deleagtes (Pharmig 2019) engaging in an interactive workshop.
Conference deleagtes (Pharmig 2019) engaging in an interactive workshop.
The sessions then moved to a workshop, presented by Monica Di Mattia and Prabhjot Parahr (from BPL), which explore the selecting of sample locations based on risk assessment in two different cleanrooms (special environments served by filtered air and supported by the application of disinfectants). Some footage of the workshop is shown in the video below:
This was followed by a session on data integrity from bioinformatics specialist Sinead Cowman, where measures to ensure data security and data robustness were considered, especially in relation to electronic capture systems. The final presentation was delivered by Edel Fitzmaurice, which looked at microbial data deviations and the importance of thorough investigations that holistically consider contamination within facilities and which are underpinned by good root cause analysis.
Delegates at the Pharmig conference.
Delegates at the Pharmig conference.
The take-home messages for the delegates was use risk assessment, but use it wisely, understanding its systematic advantages and subjective weaknesses, and to ensure that data is properly captured, reviewed and controlled.
More about Microbiology, Pharmaceuticals, Pharma, Contamination, pharmig
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