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article imageMicrobiologists review best practices for making medicines Special

By Tim Sandle     Feb 18, 2017 in Science
Birmingham - The manufacture of medicines is at risk from cross-contamination from people, a result of the shedding of microorganisms. In February a special two-day conference considered how best to manage this risk.
Medicines are manufactured within controlled environments, with medicines intended to be sterile produced in classified cleanrooms. These environments use specially filtered air, through High Efficiency Particulate Air (HEPA) filters, together with other contamination reduction measures such as air dilution. Microbial contamination risks remain, however, through personnel. Despite wearing special clothing, people can cause contamination events through shedding of skin detritus (upon which microbes can attach like people on rafts) or by touching critical surfaces.
The contamination risks from people can be minimized through appropriate behaviors; good quality gowns and methods for donning protective overalls; and through the use of disinfectants. These key areas formed the theme of a two-day conference organized by the Pharmaceutical Microbiology Interest Group (Pharmig), which was held during February 2017 at the Nailcote Hall Hotel, near to the city of Birmingham, U.K.
Nailcote Hall Hotel  located near to Birmingham  U.K.
Nailcote Hall Hotel, located near to Birmingham, U.K.
The two-day event was not only about contamination theory, it also included practical elements addressed through lectures and a hands on experience for the delegates.
Conference delegates visiting trade stands  looking at contamination control products.
Conference delegates visiting trade stands, looking at contamination control products.
The bulk of the delegates came from the pharmaceutical sector or from health services where they play a role in ensuring medicines are safe for patients in terms of being free from objectionable microorganisms (in the case of non-sterile products like creams and ointments) or free entirely (for medicines that are sterile, such as biologics intended for injection).
The first day was titled "Best Practices in Cleaning & Disinfectants", and here the emphasis was upon sound cleaning practices (to remove dirt like protein from critical work surfaces) and disinfection (the use of chemicals to inactivate bacteria and fungi).
The opening day was chaired by Rachel Blount, who is a contamination control specialist from the company Ecolab. Blout also delivered the opening presentation which provided an overview of regulations and best practice expectations. The second presentation was from Digital Journal's Tim Sandle, looking at the problem of spores. Dr. Sandle explained that bacterial spores are a problem due to their adaptive abilities in response to harsh environments. The triple structure that forms around the bacterial DNA confers resistance to many standard disinfectants and the elimination of spores requires special chemicals called sporicides.
How these chemicals work was theme of the third presentation, delivered by Laura Guardi, who is the senior QA Auditor, AstraZeneca. The presentation addressed the different modes of action taken by the chemicals to kill bacteria and fungi. To prove how well these chemicals work requires validation. How to approach validation and to achieve validation that is reproducible and robust was the theme of the fourth presentation, delivered by Kim Morwood, who is the Director of MGS Laboratories. The final presentation of the day outlined the best practices for wiping, given by Karen Rossington (European Marketing Manager, Contec); this focused on ways to avoid cross-contamination of the clean parts of the wiper (using either a two-fold or four-fold technique).
Contamination control expert Kim Morwood addresses the   meeting delegates.
Contamination control expert Kim Morwood addresses the meeting delegates.
The effective cleaning approach was followed by a presentation that looked at the key elements of a disinfection policy for a company. This was outlined by Laura Guardi. The day then moved into a series of practical demonstrations and assessments. These included how to clean and mop effectively (such as in parallel overlapping lines rather than circular motions):
Karen Rossington demonstrates how to effectively fit a mop head to a mop  in preparation for floor d...
Karen Rossington demonstrates how to effectively fit a mop head to a mop, in preparation for floor disinfection.
The process of cleaning is not as straightforward as it first appears.
The presenters show the delegates how to fit mop heads to mops  before carrying out controlled disin...
The presenters show the delegates how to fit mop heads to mops, before carrying out controlled disinfection using the triple bucket technique.
There was training in how to carefully transfer materials into clean air devices (a practice known as transfer disinfection):
Demonstrator Matt Clokey shows a delegate how best to perform transfer disinfection.
Demonstrator Matt Clokey shows a delegate how best to perform transfer disinfection.
And a workshop looking at cleanliness of surfaces, where dirt was shown through ultraviolet light detection:
Presenter Rachel Blount shows how ultraviolet light can be used to effectively screen surfaces for c...
Presenter Rachel Blount shows how ultraviolet light can be used to effectively screen surfaces for contamination.
The second day of the Pharmig meeting was headed "Best Practices in Keeping Cleanrooms Contamination Free", and it was chaired by Tim Sandle. Dr. Sandle gave the opening presentation which was about how clean spaces work, looking at the control of air filtration, air direction and air movement. This was followed by a talk that looked at how people should behave within cleanrooms as to minimize the risk of cross-contamination; this presentation was given by Laura Guardi.
The third presentation came from Tim Eaton, who is the Sterile Manufacturing Specialist for AstraZeneca. This looked at the specifications for cleanroom clothing, where the best garments act as filters as to keep microorganisms that fall from the skin within the gown. Eoaton also delivered the fourth presentation of the day, which followed on in looking at how often gowns can be worn (in terms of relaundering, since laundering over time damages the weave of the fabric).
The quality of gowns, gloves and masks was taken further in terms of scientific research proving that they work by Carsten Moschner, who is the chairman of the German group the VDI Association.
Carsten Moschner delivering a lecture on effective fabrics and wipes for contamination control  Febr...
Carsten Moschner delivering a lecture on effective fabrics and wipes for contamination control, February 2017.
This presentation included test data about microbial retention and glove integrity.
Cleanroom gloves need to be integral to stop contamination from a person s skin affecting medicines ...
Cleanroom gloves need to be integral to stop contamination from a person's skin affecting medicines during manufacture.
A practical session then followed. This consisted of a good gowning practice demonstration by Simon Fiala, who works for the Austrian company COMPREI Reinraum.
How to wear a cleanroom suit properly? Simon Fiala demonstrates a fast and effective technique.
How to wear a cleanroom suit properly? Simon Fiala demonstrates a fast and effective technique.
The video below outlines the tricky technique:
Following the demonstration, the delegates practiced gowning by putting on cleanroom suits (to varying degrees of success). First, suits need to be unraveled and no parts, including the arms and legs of the suit can touch the floor.
Delegates attempt to unwrap and out on cleanroom suits carefully  with mixed results.
Delegates attempt to unwrap and out on cleanroom suits carefully, with mixed results.
Some of the delegates manage the process better than others.
The delegates put on the cleanroom suits with different degrees of dexterity.
The delegates put on the cleanroom suits with different degrees of dexterity.
But they all get there in the end.
One group of delegates wearing their white cleanroom suits.
One group of delegates wearing their white cleanroom suits.
The final presentation of the day was from Kim Morwood who looked at best practices for hand sanitization. This is a critical area, for if gloves are not correctly sanitized then microorganisms can be transferred on touch from an operator to a medicinal product.
The two-days balanced scientific theory with practical approaches and hands-on demonstrations. The microbiologists in attendance returned back to their workplaces with sounder knowledge and better practices to help keep medicines safe.
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