highlights
8 Issue 3 2020
Containment and pharmaceutical HVAC validation training Highly successful first session of the ALPA Academy
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arlier this year, ALPA (Air & Lab Products Africa) co-hosted an in-depth training session together with Air Techniques International. Presented by Tim Triggs, EMEA Regional Director – Air Techniques International, who flew to South Africa specifically to present the courses on containment and pharmaceutical HVAC validation training, the four courses focussed on: • Airflow measurement (in cleanrooms or controlled environments) • Cleanroom classification (sampling airborne particles, numbers and sizes) • HEPA filter integrity testing • Microbiological Safety Cabinets and their certification in accordance with EN12469.
electronics, aerospace, automotive and laboratory sciences. Delegates were equipped with expanded knowledge on cleanroom and equipment designs, airflow principals, units of measurement, types of instruments, and the testing required. Cleanroom classification is another important facet of our industry. There is a requirement in all cleanrooms and controlled environments to sample the airborne particle numbers and sizes for determining classification to ISO14644-1. Other regulated industries such as pharmaceutical and life sciences require testing for GMP classification, and
monitoring for control, following the same procedures. Particle counting is more complex due to changes in the Standards and the technology used in Particle Counters. The course covered the types of cleanroom and clean air devices, the instrumentation to use and the functions, and how to test for classification. HEPA filter integrity testing also formed part of the four-day training session. There is a requirement in all clean air and containment industries to test the HEPA filter systems that protect people, product and environment. ISO14644-3 describes the installed filter leakage test, commonly
At the end of each course, an exam on the theoretical training was undertaken. The training took place from 20 to 24 January at Edgecombe House in Blue Hills, Midrand and attendees included consulting engineers, certifiers and quality assurance managers from the clean room and filtration industries. Airflow measurement is critical to creating and maintaining a cleanroom or controlled environment and is a paramount requirement in applications for such industries as pharmaceutical, healthcare, nuclear, semiconductor,
The team presenting the training: Gregers Chalker, Preston Ngoyi, Lungile Mpofana, Thiloshini Pillay, Tim Triggs, Francois Swart
referred to as the DOP (Dispersed Oil Particle) test. Being the preferred method in all industries except microelectronics, this test is global and, whilst it appears simple, it can, in fact, be quite complex. The course covered testing installed HEPA filters, the most current equipment and the latest best practices. Microbiological Safety Cabinets and certification in accordance with EN12469 – MBSCs are extensively used in containment applications throughout industries such as pharmaceutical, healthcare, nuclear, and laboratory sciences. Legislative requirements together with the European Biotechnology Standards and British Standards for safety cabinets make it vital that all those responsible for efficient and safe working of containment systems are familiar with both the theory and practice of their operation, performance and testing. Should any Analytical Reporter readers be interested in similar training, please give ALPA a call or email sales@alpa.bz.
ALPA (AIR & LAB PRODUCTS AFRICA) Tel: (064) 870 4046 sales2@alpa.co.za www.airlabproducts.co.za
New agency in SA with potential to accelerate optimal antibiotic treatment for critical patients with blood sepsis L
abotec has been awarded the exclusive agency for Accelerate Diagnostics in southern Africa. The Accelerate Pheno System represents a first for the fastest coupled pathogen identification and antibiotic susceptibility testing (AST) technology currently available. Independent studies show the Accelerate Pheno System provides
identification and susceptibility results with MICs approximately 40 hours faster than the methods used in the current standard of care.* This next generation microbiology solution has the potential to dramatically improve the outcome of critically ill patients and reduce their length of stay in ICUs in southern African hospitals. The Pheno system takes 90 minutes to identify mono/polymicrobial communities and seven hours to conclude AST. The definitive diagnostic measurement used is the minimum inhibitory concentration, or MIC, which provides the most conclusive information to determine which antibiotic would be
most effective in each patient’s situation. With the Accelerate Pheno system, MIC results are available about one to two days faster than current methods. At the launch demonstration on 10 March at Labotec (Midrand), Harold Derkx from the Netherlands and Dr. Michael Wilke, the Managing Director from Inspiring-health in Germany, presented on how patients can be moved from empiric to optimal therapy faster using the Accelerate Pheno system. Powered by Morphokinetic Cellular Analysis (MCA), the system is the first to track phenotypic features of microbial growth in individual viable cells, which are then grown into micro-colonies in the presence antibiotics. When interpreted, the system determines which antibiotic would be most effective in combating the blood sepsis. The only consumable used is a single kit for which an entire test cycle can be automatically processed, directly from positive blood culture. The total hands-on time to load the system and begin fully-automated analysis is two minutes. The system will automatically filter out cellular debris and
other contaminants like salts, proteins, etc. using gel electrofiltration. For more information, please visit: https://www. labotec.co.za/product/accelerate-phenosystem/. Timing is of vital importance in a busy hospital, and Labotec hereby presents a solution to reduce the time it takes to optimal antibiotic therapy for critical blood sepsis patients, as well as the betterment of antibiotic stewardship. All of this, with the added benefit of reducing the length of stay for patients in intensive care units in southern Africa, makes the Accelerate Pheno System ideal for hospitals and patients. *Based on peer-reviewed publications comparing IVD-cleared methods through June 2019.
LABOTEC (PTY) LTD JHB: (011) 315 5434 CPT: (021) 531 7660 DBN: (031) 566 4870 Fax: (011) 315 5882 sales@labotec.co.za www.labotec.co.za
