The safety of medicines is of great importance, needing to be of the required formulation and contamination free. Recently, in Oxford, U.K., pharmacists and microbiologists came together to review best practice.
The event, held on March 2 and 3, 2016, was hosted by the Pharmaceutical Microbiology Interest Group (Pharmig.) Day one of the event was more general, and it looked at the best strategies for ensuring the environments within which medicines are prepared and put into final containers is safe. The second day was more specific, assessing an important subject of avoiding bacterial and fungal spores entering into products. A unifying theme with the second day was the use of special, highly aggressive disinfectants called as "sporicides."
The two day meeting drew over 50 delegates, over 20 exhibitors and specialist speakers. The meeting was held in a new hotel — The Oxfordshire — which overlooks the sprawling delights of Oxfordshire, the epitome of the English countryside (Digital Journal has also reviewed the hotel and its facilities in a separate article.)
The first day, facilitated by the chair of Pharmig David Keen (from GlaxoSmithKline), began with a presentation from Tim Sandle (speaking in an independent capacity). Dr. Sandle compared the differences between U.S. and European guidances for assessing contamination in cleanrooms. A cleanroom is a specially designed, contained room, with filtered air (through a HEPA filter) and a high level of air-changes, so that any contamination is (in theory) removed from the room. The problem with cleanrooms arise when people are placed in them, for people continually shed skin detritus and some of these very small particles (on the micronmeter scale) act like rafts, carrying bacteria.
The key difference between U.S. and European regulations, Dr. Sandle explained, is for the cleanest areas the U.S. approach is to count non-zero events and to react to adverse trends; whereas the European approach is to react to actual counts, and assess the individual impact of each.
The second presentation was from David Keen, which looked at a strategy for rolling out an environmental monitoring program. Of particular use was looking at where points of microbial contamination are likely to occur and ensuring samples are taken in these locations, rather than putting out agar plates away from where work is actually going on. This may seem like common sense, but Mr. Keen pointed out, from his experience of visiting different pharmaceutical manufacturing sites, there is a bewildering array of practices.
Dr. Sandle presented again for the third presentation. This looked at the best methods to capture both bacteria and fungi. This is not straightforward because the organisms — from two different microbial kingdoms — prefer growing on different media. The trick is to develop an incubation strategy, examining the factors of time and temperature. Dr. Sandle outlined a recent paper he had written, which recommended using a lower temperature first (20-25 degrees Celsius), which encourages fungal growth and does not kill bacteria, and then incubating at a higher temperature (30-35 degrees Celsius). The risk of not doing so could lead to a destruction of lytic cellular enzymes, which can kill some fungi.
The fourth presentation was delivered by pharmaceutical consultant Julie Roberts. This looked at how to identify microorganisms recovered from the environment and the differences between phenotypic technology (which looks at how an organism interacts with its environment) and genotypic methods, which look at the microbial genome. The presentation also discussed how many identifications should be performed in order to create a meaningful picture of the production environment.
This was followed by a presentation by Erika Notman (a pharmaceutical sector consultant.) This presentation consider case studies for investigating high microbial counts and the sorts of things to look for, such as poor cleaning techniques or environmental control failure.
The final presentation from day one was delivered by Julie Roberts and this touched on the subject of data integrity. Readers of Digital Journal will be aware about this subject as it touches on either the mis-recording of data or even the falsification of data, designed to make a drug product appear safe when it is, in fact, adulterated.
At the end of the first day, delegates had the opportunity to walk the hotel grounds. Too late for a round of golf (for those interested in the small ball and stick sport); the views were nevertheless impressive.
The second day was orientated more towards the health sector and hospital pharmacy units. There were aspects, however, of interest to the pharmaceutical sector as well. The day was chaired by Tim Sizer, who is the Regional Pharmaceutical Quality Assurance Officer South West.
The aim was to provide an updated overview of the risks associated with bacterial and fungal spores within the aseptic preparation environment (where medicines intended to be sterile are formulated and filled.) The day also set out to review recent incidents causing harm to patients and to discuss new guidance, such as the Medicines and Healthcare products Regulatory Agency (MHRA) — the U.K. medicines regulator — new "Guidance to Specials Manufacturers."
The first presentation of the day was from Tim Sandle. Here Dr. Sandle provided an overview of spores, both bacterial and fungal, and explained why they are so resistant to common disinfectants. With bacteria, this is due to a three-layered spore coat, and the ability of some spores to stick together. For fungi, the problems are with the sheer number and the ability of some to secrete an enzyme that can inactivate disinfectants. While the use of a potent sporicidal disinfectant is important, the key message from the presentation was to focus on a good biocontamination control strategy.
The second presentation of the day was delivered by Tim Sizer. This ran through some of the more recent pharmaceutical and pharmacy contamination events. These included the infamous New England Compounding Center (NECC) issue, where contaminated vials of a steroid were distributed across the U.S. The case count is still being tallied up, and stands at almost 800 infected and over 70 deaths.
The third address was from Mark Oldcorne, who is the All Wales Quality Assurance Specialist Pharmacist. In this presentation the advantages gained in reducing contamination events from different types of disinfection were discussed. Data was presented showing sanitization by gassing to be the most effective, followed by the use of spraying and wiping or a sporicidal chemcial. Without wither of these two measures, other data indicated a low but ever present microbial contamination risk.
The fourth presentation was delivered by Rachel Blount, who is the Global Validation Manager of the company Ecolab. The presentation was designed to enable the user to interpret the methods adopted to validate disinfection efficacy. Here Rachel Blount explained the different international standards for testing disinfectants to show that they actually work.
The next presentation was again by Tim Sandle. In this second presentation, Dr. Sandle set out to consider the types of sproicidal agents available on the market and the limitations of their use. The choice of sporicides is quite narrow, once health and safety issues and ease of use have been considered. These are either chlorine based (such as chlorine dioxide, hypochlorus acid, chloramine, or hypochlorite) or oxidizers like peracetic acid or hydrogen peroxide. Dr. Sandle was keen to emphasize that the claims of manufacturers should not be taken at face-value and laboratory studies were needed to confirm biocide effectiveness.
The day also included a workshop, where delegates simulated disinfecting and transferring vials. Here there was a variety of different practices, indicating that a common standard was required. Based on this, the pharmacists present undertook to continue to develop best practice for the transfer disinfection process and potential alternatives.
The practical including advice on how to disinfect the outer surfaces of vials, used to store medicine, correctly.
There was also an opportunity learn about spraying disinfectants, with a view to getting the right quantity onto a wipe.
The final presentation was from Mark Oldcorne, which considered some best practices from aseptic processing, focusing on materials being transferred into and out of controlled environments.
The two day Pharmig event was well organized and helped to reinforce best practices and the appropriate standards for microbiological contamination control.
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