Beating the bioburden: how clinical, pharma and food labs can achieve continuous contamination air control
How can analytical laboratories stay on top of the ever-present threat from microbial bioburdens? Which steps should they take to ensure that products, processes, and premises all conform to key ISO standards or other guidance? And what role can proficiency testing play in improving and sustaining the performance of your lab?
Environmental microbial control is a key part of all good manufacturing processes – but particularly so in the pharmaceutical and food sectors.
The numerous ways that a manufacturing product can acquire a microbial bioburden – including raw materials, processing, and packaging – make contamination control a 24/7 concern, every day of every year.
And in the clinical sphere, where keeping operating theatres, equipment manufacturing and other key areas free from contamination can be a matter of life and death, getting on top of airborne bioburdens is even more critical.
The threat from microbes in air also means that analytical laboratories supporting the clinical, pharma and food sectors need to develop and maintain robust air sampling and testing processes that conform to today’s exacting ISO standards or FDA guidance for microbial contamination.
Sensitive locations such as cleanrooms need to conform to a range of international standards –to ensure that they can operate consistently in an environment free from airborne hazards such as bacteria, yeast and mould.
Ambient air naturally carries a number of particles from various sources, including humans. One study has shown that a person’s mere presence in a room can add 37 million bacteria to the air every hour. Airborne particles can be divided into two categories: non-viable particles (typically metals, dust, chemical compound, etc.) that do not contain micro-organisms but can carry them, and viable particles - such as bacteria, fungi or spores. Viable particles are a source of microbiological contamination when they come into contact with a product or surface.
Given the risks and stringent regulations associated with microbial contamination, it is vital for pharma, food, and clinical organisations to have confidence in the accuracy of the air quality analysis that supports their operations. And, because of the key role that analytical laboratories play in testing and interpreting samples, it is more important than ever that they systematically scrutinise and assess their own performance.
This is where enrolling in a proficiency testing (PT) scheme can help. Regular participation in PT ensures that your laboratory’s results are assessed independently for accuracy, and is essential to achieving accreditation to ISO/IEC 17025 and/or ISO 15189. This, in turn, lends further confidence to the manufacturing and clinical processes you support.
Labs can also use PT results to verify their processes – including methods, sample handling, equipment, and calibration – and to manage early warning signs, leading to the rapid resolution of problems.
For over 40 years, AXIO Proficiency Testing has been a trusted partner for laboratories working to keep their premises and processes free from airborne microbial contamination. By participating in our proficiency testing schemes regularly, you can have confidence in the measurement of your results.
We move with the world’s changing demands, which is why we’ve launched a new bioburden of air sample (PT-HY-09) to verify your analysis of Total Viable Count and yeast and mould in air filters.
Drawing on decades of proficiency testing and our truly global reach, AXIO is your perfect partner in proficiency testing.
Head to lgcstandards.com/AXIO to find out more and place your order.
LGC. Science for a safer world.