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AB SCIEX achieves ISO 13485 certification for manufacturing of LC/MS systems, and opens Asia Pacific Application & Training Centre in Singapore’s biomedical hub
AB SCIEX, a global leader in life science analytical technologies, today announced that it has achieved ISO 13485 certification for its quality management system. This certifies an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices. Such certification is often considered a first step toward complying with European regulatory requirements for a device to be cleared for use in the clinic. AB SCIEX currently manufactures and sells LC/MS/MS systems for research use only.
‘AB SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,’ said Rainer Blair, President of AB SCIEX. ‘Achieving the ISO 13485 certification is an important measure toward realising the vision of our LC/MS/MS systems to be cleared for use in clinics. The potential impact of mass spectrometry technologies on clinical diagnostics is significant.’
The ISO 13485 certification covers AB SCIEX’s manufacturing facility in Singapore as well as its R&D design center in Toronto, Canada. AB SCIEX is a leader with more than 20 years of innovation and market leadership. Its instrumentation is used in clinical research, forensic toxicology, biomedical research and drug discovery and development. The achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of AB SCIEX instruments as well as the company’s commitment to continuous improvement.
AB SCIEX has also announced the opening of its newest APAC Regional Application & Training Centre. Located in Singapore’s biomedical hub at Biopolis, this centre provides comprehensive service, support and application development to enable the scientific community in Singapore and the rest of ASEAN, Australia New Zealand, Japan and Korea to continue its increasing use of mass spectrometry technologies for a broad range of applications. The new Singapore facility complements the regional application support centre that the company opened last year in Shanghai, China.
This Singapore facility serves as a regional hub for the scientific community to learn about the latest innovations in analytical-based laboratory instrumentation. Its primary functions include sample analysis, instrument and workflow demonstrations, comprehensive training programs, region-specific applications development, on-site and remote customer support, and scientific collaborations with research leaders in a variety of life science disciplines. The company has a long history of partnership throughout the life science industry within Singapore and across the Asia Pacific region. It serves a broad range of customers in government agencies, academic research, clinical research and pharmaceutical industries.
‘Leading companies such as AB SCIEX continue to play an important role in the development of Singapore’s biomedical sciences sector by providing the latest tools to advance our efforts in drug discovery research. This new centre is an excellent example of how companies can foster synergies and partnerships with the research community in Biopolis to develop innovative and region-specific solutions for Asia,’ said Mr. Kevin Lai, Deputy Director, Biomedical Sciences, Singapore Economic Development Board.’
‘AB SCIEX continues to be a trusted partner for our customers and collaborators in Singapore and throughout the Asia Pacific region,’ said Johnson Ho, Vice President of Sales, Asia-Pacific. ‘Our new APAC Regional Application & Training Centre represents our commitment to deliver world-class service and support to help our customers address critical issues, such as food safety, environmental contamination and the accuracy of clinical research results.’
AB SCIEX www.absciex.com
Over the last three years, the haematology laboratory at Sheikh Khalifa Medical City (SKMC) in Abu Dhabi has introduced two STA-R Evolution analysers to fully automate coagulation testing. CLI spoke to Dima Yassin, Senior Supervisor in the haematology lab at SKMC, to discover how the new system has improved quality and efficiency in her lab and benefited both patients and healthcare personnel.
Q. Could you first tell us a little about the Sheikh Khalifa Medical City. What is its structure, how is it managed and what patient population does it serve?
Sheikh Khalifa Medical City (SKMC), managed by Cleveland Clinic, serves as the flagship institution for SEHA, Abu Dhabi’s healthcare organisation. SKMC was formed in 2005 as a result of merged healthcare entities in the Island of
Abu Dhabi.
SKMC comprises a 568 bed acute care hospital, 14 outpatient speciality clinics and a blood bank, all accredited by Joint Commission International (JCI). In addition, SKMC manages a 125 bed behavioral sciences pavilion, six family medicine clinics, two urgent Care Centres and two dental Centres.
Q. How is the diagnostic laboratory structured and roughly how many tests are carried out per day?
The diagnostic laboratory in SKMC is a CAP (College of American Pathology) accredited laboratory. The laboratory offers a full range of clinical laboratory services for the detection and diagnosis of disease. These services include phlebotomy, anatomical pathology, cytology, clinical chemistry, haematology/coagulation, microbiology, blood transfusion, a donor blood bank unit, immunology, serology, molecular pathology, histocompatibility testing and point-of-care testing. We run around 160,000 procedures per month.
Q. How many of these tests involve the haematology lab, and which tests are most frequently carried out in this lab? Are coagulation tests a major part of your workload and is this increasing? Do you carry out coagulation tests on pre-surgical patients as well as on patients who have coagulation abnormalities, or are on anticoagulation therapy?
In the haematology department at SKMC, we process around 1000 specimens per day, which include routine haematology and coagulation testing, special haematology and coagulation testing, bone marrow processing and flow cytometry. Coagulation is a vital part of our testing activities, which include monitoring patients on anticoagulant therapy, pre-surgical screening and investigation of coagulopathies.
Q.When did you invest in STA-R Evolution automated coagulation analysers for these tests and what were your reasons for choosing these instruments?
We installed the first STA-R Evolution analyser in our lab in 2008, and then followed this by the second STA-R Evolution analyser in 2010. Because the work load was increasing, we had decided we needed a fully automated stand-alone work station with high throughput and rapid processing of STAT samples
without the need to interrupt the current testing.
Q.What effect did the introduction of these analysers have on the organisation and productivity of the lab, and particularly on TATs?
The STA-R Evolution analysers are fully automated coagulation analysers designed to integrate comprehensive testing with minimal hands-on specimen handling. The analysers are fully integrated with the Laboratory Information System, which reduces turnaround times, increases quality and improves efficiency in the pre-analytical processing of specimens.
Q.Were you satisfied with the training and technical support you received?
The efficiency during the implementation, and in the planning and training provided by Diagnostica Stago played a vital role in the success of this project. This support continues to be available, with technical support provided as well as further updates and training workshops.
Q. Will you still be able to cope should your workload increase substantially?
Recently, we implemented a fully automated coagulation line integrated with two STA-R evolution analysers. This new technology is designed to accommodate a larger volume of work that can be completed in an efficient and timely manner.
Q.Finally how would you say that medical and technical staff, and most importantly the patients, have benefited from the introduction of these coagulation analysers?
The automated system eliminates almost all hands-on specimen handling for routine tests. It improves turnaround times and ensures that specimens are processed in an efficient and consistent manner. This allows us to provide high quality patient care.
Diagnostica Stago
Asnières sur Seine, France
Opened in 2011, the Institute of Molecular Biology gGmbH (IMB) at Johannes Gutenberg University, Mainz, Germany is housed in a brand new building with state-of-the-art scientific facilities. The architect suggested that ultra-low temperature freezers housed in the Institute’s Core Facilities should be capable of being linked to a central water-cooling system, an integral part of the building’s modern infrastructure.
Centre of excellence
Described as ‘a centre of excellence in the life sciences in the heart of Europe’, IMB has been funded for an initial period of ten years by the Boehringer Ingelheim Foundation, a charity dedicated to promoting outstanding research in medicine, biology, chemistry and pharmaceutical science. As a non-profit entity, which operates like an innovative academic research centre, IMB focuses on key questions in developmental biology, epigenetics and DNA repair. The aim is to transform our understanding of how we develop, adapt to our environment, age and develop diseases such as cancer.
IMB’s core facilities
Researchers at IMB have access to cutting-edge technologies and the latest equipment provided centrally. This arrangement has significant benefits, as Dr Bernhard Korn, Director of IMB Core Facilities, explains: ‘The decision to set up centralised resources comprising cost-intensive instrumentation and high-level expertise enables even small research groups at IMB to run ambitious major projects’.
‘Secondly, it is much more economical for the Institute to run instruments and equipment, such as freezers, at the limit of their capacity by sharing resources among multiple users. In addition, by locating our ULT freezers together in a dedicated area we can make use of a centralised monitoring and alarm system which constantly checks the temperature, power supply and cooling water for all units.’
Selecting ULT freezers
IMB chose to equip its core facilities with 23 SANYO MDF-U74V upright -86ºC freezers and three of the company’s MDF-C2156VAN cryogenic freezers. All are equipped with the water-cooled condenser option, to meet a requirement to utilise the Institute’s water-cooling system. The space-saving -86ºC freezers are used to hold a collection of more than 25,000 different human protein-coding clones, while the -150ºC freezers store a large number of human cell lines, tumour cell lines and tissue samples. Later, patient specimens will also be stored prior to the extraction of nucleic acids and proteins.
According to Bernhard Korn, ‘Installing SANYO freezers was essentially a ‘plug-and-play’ experience for us. The freezers arrived, they were hooked up to the cooling water, switched on and they worked. They provide a very stable, constant environment with no temperature fluctuation – this is what we really love about them. The insulated inner doors on the MDF-U74 model reduce temperature change when the freezer is opened and there is enough space for large boxes. A wide choice of shelves provides the flexibility to accommodate the storage needs of our different research groups. These freezers are very easy to operate and we like the fact that the main power switch is on the side. This means there is no danger of a unit being turned off accidentally – a recognised hazard if this switch is placed on the front panel.’
Advantages of water-cooling
The architect of the IMB building suggested that wherever possible, equipment should be water-cooled, rather than relying on traditional air cooling. So, in addition to ULT freezers, there are centrifuges, laser systems and sterile work benches which are also connected to the building’s central water-cooling system.
As Dr Korn points out, there are various advantages to water-cooling freezers, ‘With less heat dissipated in the freezer room only ventilation is needed, rather than air-conditioning that not only requires energy but wastes heat. In fact with a total of over 100 instruments throughout the Institute hooked up to the water-cooling system, only a very few labs and measurement rooms, around five per cent of the total space, require active cooling.
‘Water is circulated at 18ºC and leaves the freezers at 23–24ºC. However, this heat energy is not wasted as the warmed water is used to contribute to the central heating for the whole building. Therefore the Institute is able to reduce energy costs and benefit the environment.’
SANYO’s water-cooled ULT freezers incorporate a double plate heat exchanger which maximises energy transfer from the refrigerant to a closed water circuit. As water is more efficient than air at removing heat, the compressor efficiency is improved. As a result, not only is energy consumption 15–20 per cent lower than for an equivalent air-cooled model, but temperature recovery after door opening and sample loading is faster, protecting samples.
Further developments at IMB
2012 will see IMB expanding to its full complement of around 12 groups, with the core facilities being extended to support the additional researchers. The success of the current water-cooled ULT freezers is underlined by plans to add five or six more of the same -150ºC freezers and up to ten of the -86ºC models, all with water-cooled condensers.
Dr Korn commented, ‘SANYO is well known not only for the quality and reliability of its ULT freezers, but also for building good customer relationships and providing excellent technical support. Another important factor for IMB is the high level of service and full guarantee provided by EWALD Innovationstechnik GmbH, the German distributor. Although initially more expensive than equivalent air-cooled freezers, choosing the water-cooled condenser option enables the Institute to use less energy and make significant savings in the medium and long term. We believe this is the way to go for the future.’
Institute of Molecular Biology GmbH
funded by the Boehringer Ingelheim Foundation
Ackermannweg 4
55128 Mainz
Tel: +49-6131-39-21501
www.imb-mainz.de
SANYO E&E Europe BV
Biomedical Division
Tel. +44 (0) 1509 265265
www.eu.sanyo.com/biomedical
March 2026
The leading international magazine for Clinical laboratory Equipment for everyone in the Vitro diagnostics
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