29 minute read
Pharma Notes
Amorfix Life Sciences Ltd.
(Toronto, ON) has changed its company name to ProMIS Neurosciences Inc. with its common shares now trading on the Toronto Stock Exchange under the stock symbol (PMN). With a focus on precision medicine solutions for early detection and treatment of neurodegenerative diseases, the company is developing antibody therapeutics and specific companion diagnostics for Alzheimer’s disease (AD) and amyotrophic lateral sclerosis (ALS). Among the diagnostics that ProMIS Neurosciences is developing is ProMIS (Trademark symbol) a computational discovery platform that predicts disease specific epitopes on the molecular surface of misfolded proteins.
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Canadian CRO Dalton Pharma Services (Toronto, ON) reports it has signed a drug development and manufacturing contract with fellow Canadian company Ramsey Lake Pharmaceutical Corp. (RLPC) (Sudbury, ON). RLPC is a privately held company developing therapies currently focused on proteasome inhibitors. Its lead candidate, VR23, is a small molecule cancer therapeutic that has shown potential as a next generation proteasome inhibitor, inhibiting tumour growth as a single agent that used in combination with gold-standard anticancer drugs, increases efficacy while reducing toxicity. It has also shown potential in overcoming drug resistance. The product was developed in the laboratory of Dr. Hoyun Lee of RLPC. Dalton Pharma will assist RLPC in toxicology studies for VR23 and the agreement includes the synthesis of the molecule by Dalton as well as the development of analytical testing methods and execution of a stability study.
Immunovaccine Inc. (Halifax, NS) has entered into a non-exclusive clinical trial collaboration with Incyte Corporation (Wilmington, DE) to evaluate the combination of its T-cell activating immunotherapy, DPX-Survivac, with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat. Both firms say they will co-fund and conduct a Phase 1B trial to evaluate the safety, tolerability and efficacy of the new combination in platinum-sensitive ovarian cancer patients who are at high risk of recurrence. The investigational new drug (IND) application for the study, which will test the triple combination of DPX-Survivac, epacadostat and low dose oral cyclophosphamide, is expected to be filed this year in the U.S. and Canada and the study is expected to enroll approximately 20 patients. Results from this study may lead to an expansion of the clinical collaboration to investigate other cancers.
Telesta Therapeutics Inc.
(Montreal, QC) says that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MCNA. MCNA is a biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy. It is derived from the cell wall fractionation of a non-pathogenic bacteria.The FDA has a 60-day filing review period to determine whether Telesta’s BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA’s official filing communication known as the “Day-74 letter.” Telesta will communicate the FDA’s filing decisions upon receipt. Additionally, the company has received a waiver from the FDA exempting the company from a $US2.3 million payment for a BLA application fee.
Aeterna Zentaris Inc. (Quebec City, QC) reports it has reached its goal of recruiting 500 patients for its Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study in women with advanced, recurrent or metastatic endometrial cancer. The ZoptEC trial is being conducted in more than 120 sites in North America, Europe and Israel. It is an open-label, randomized-controlled study, comparing the efficacy and safety the hybrid molecule that is composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). The primary efficacy endpoint is improvement in overall survival.
Clementia Pharmaceuticals,
Inc. (Montreal, QC) reports the completion of a US$60 million mezzanine round of financing to support the development of its lead compound palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP). Palovarotene, an investigational retinoic acid receptor gamma agonist, is currently in Phase 2 clinical trials for patients with FOP. It was in-licensed from Roche, who previously were testing it as a treatment for COPD. New Enterprise Associates (NEA) was the lead investor with participation by UCB, RA Capital Management, Rock Springs Capital Management, EcoR1 Capital, and a fund advised by Janus Capital Management LLC as well as existing investors OrbiMed Advisors and BDC Capital Healthcare Venture Fund.
Qu Biologics Inc. (Vancouver, BC) reports it is collaborating with the laboratory of Dr. Bruce Vallance at the Child & Family Research Institute at BC Children’s Hospital and the University of British Columbia. The company is developing Site Specific Immunomodulators (SSIs) that aim to restore normal immune function in targeted diseased organs. It has tasked Dr. Vallance’s team with studying the therapeutic effects of its SSI treatment for inflammatory bowel disease (Crohn’s disease and ulcerative colitis) in a mouse model that mimics the underlying innate immune system defect and chronic bacterial infection associated with these diseases. Well recognized for his expertise in the study and modeling of IBD and enteric bacterial infections, Dr. Vallance was named the Canada Research Chair in Pediatric Gastroenterology and a Michael Smith Research Scholar in 2004. He has authored more than 60 peer reviewed manuscripts addressing the mechanisms underlying IBD and infectious diseases.
Cipher Pharmaceuticals
(Mississauga, ON) reports Ferrer International SA has successfully completed the second Phase 3 clinical trial for Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer in January 2015. The study, which involved Ozenoxacin formulated as a topical treatment for dermatological infectious conditions in adults and peadiatric patients aged two months and older, demonstrated that Ozenoxacin 1% cream, applied twice daily for five days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7) performed well and was shown to be safe and very well tolerated in the adult and paediatric population.
Cardiome Pharma Corp. (Vancouver, BC) has submitted a supplemental new drug submission (sNDS) to Health Canada’s Therapeutic Products Directorate for AGGRASTAT®. The sNDS includes data to support: 1) high dose bolus administration of AGGRASTAT (tirofiban hydrochloride); and 2) an indication expansion for the reduction of major cardiovascular events in patients with acute myocardial infarction (STEMI) intended for primary PCI. AGGRASTAT, in combination with heparin and ASA is currently indicated in Canada for the management of patients with unstable angina or non-Q-wave myocardial infarction, including patients who may subsequently undergo PTCA (percutaneous transluminal coronary angioplasty), to decrease the rate of refractory ischemic conditions, new myocardial infarction and death. Cardiome acquired the Canadian AGGRASTAT commercialization rights through its acquisition of Correvio LLC in November 2013.
Aequus Pharmaceuticals, Inc.
(Vancouver, BC) has successfully completed an in vivo feasibility study with AQS-1301, a proprietary transdermal patch containing the psychoactive drug aripiprazole. The pharmacokinetic study was conducted in animals in order to estimate the effectiveness of the formulation in delivering therapeutic amounts of the drug over a seven day period. According to Aequus CEO and chairman Douglas Janzen, the patch delivered the drug at a very consistent rate. The company also said it has received a Notice of Allowance from the U.S. Patent Trademark Office (USPTO) for a pharmaceutical formulation patent application that covers AQS-1301. Similar applications have been filed with the European Patent Office (EPO) and the Patent Cooperation Treaty (PCT).
The European Commission has granted ProMetic Life Sciences (Laval, QC) orphan drug designation status to its human plasma derived plasminogen drug. ProMetic is currently investigating the safety, tolerability and pharmacokinetics of the drug in patients suffering from plasminogen deficiency. The company expects to provide a preliminary report on its program shortly
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BY GENE SHEMATEK
Clean or Contaminated?
ONE OF THE FREQUENTLY ASKED QUESTIONS about laboratory safety concerns the
designation of ‘clean’ and ‘dirty’ or ‘contaminated’ areas. Usually, laboratories will designate areas that are considered ‘clean’ and those considered ‘contaminated’. In general, a contaminated area is one where the risk of exposure to a hazardous agent (chemical, biological) is elevated: so this includes most laboratory work areas. The idea is that contamination should not be transferred to clean areas. Contaminated areas require controls – precautions to prevent exposure to the hazards – hence the need for personal protective equipment and administrative controls such as no eating or drinking in the lab (which may enable the hazard to gain access through a body’s portal of entry). The US Centers for Disease Control and Prevention covers this topic in its Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories1 providing the following guidelines:
3.16. Clean versus Dirty Areas of the Laboratory
In the microbiology laboratory, all the technical work areas of the department are considered dirty. The same concepts of demarcation and separation of molecular testing areas that are described in this section can be used to establish clean and dirty areas in other parts of the diagnostic laboratory.
3.16.1. Clean areas
• Wear different colour laboratory coats in clean and dirty areas of the laboratory (have them available at entrance to clean areas), or require no laboratory coats in clean areas. • Decontaminate reusable materials and devices (e.g., telephone, clocks, computers, tissue boxes, work books) brought into the clean area unless they are known to be
new, and immediately apply laboratory-designated, colour-coded tape. • A visual reminder on small objects such as workbooks, tissue boxes, and pens can easily identify items located to a clean area. • Demarcate separation of dirty and clean floor areas with tape (tape must stand up to floor cleaning)
to clearly denote clean/dirty area boundaries. • Develop a policy for cleaning and maintaining clean areas. • Train all personnel (including service personnel) regarding how to identify and maintain clean areas and to recognize the significance of the demarcation tape and other means of area identification. • Document training and assess competency in use of and maintaining clean areas.
3.16.2. Offices
Offices (e.g., of supervisors and laboratory director) that open into the clinical laboratory represent hybrid areas within the laboratory. These offices are not typically designed or maintained in a manner that allows for easy or efficient disinfection. • Keep a supply of hand disinfectant gel in all office and work areas and use the gel frequently. • Components of offices that should remain clean but may be overlooked include: laboratory documents, reports, and records; small equipment; pens; procedure manuals and other items that have been in the laboratory and could have been handled with gloved hands;
carpets and chairs that are difficult to disinfect; books, journals, and other reference materials that can be taken into the laboratory or taken for use outside the laboratory; personal items (e.g., photographs, awards, briefcases, coats, boots, backpacks, purses, personal electronic devices) that are difficult to disinfect and would not be allowed in the general laboratory; and food items.
• Designating office areas as “clean” does not necessarily make or keep them uncontaminated, especially when potentially contaminated items are brought into the office and reference materials and documents move freely between the office and laboratory. The following procedures can help reduce the risk of contamination in laboratory office areas.
Never bring specimens, cultures, proficiency samples and similar items into office areas. Remove PPE before entering the offices and wash hands before entering these areas. Establish a dedicated and protected clean area for personal items (e.g., purses, briefcases, and similar items). Disinfect desks and personal workspaces, telephones and computer keyboards in office areas regularly. Refrain from touching eyes, nose, mouth and lips while in office areas. Do not place pens, pencils, eyeglass bows, or other items in the mouth or against the lips. Do not apply or permit cosmetics in office areas. Do not store food in the office. Wash hands after working in the office and before entering common areas such as rest rooms, administrative areas, cafeteria, and the library. Avoid clutter in office areas as much as possible. Boxes, papers, and other items make the office
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difficult to clean and decontaminate. Laboratory directors and supervisors are responsible for assessing the exposure risks associated with use of laboratory documents and reference materials in the dirty areas of the laboratory and developing use policies to minimize those risks.
3.16.3. Dirty areas
• All areas of the working laboratory including all equipment, keyboards, waste and surfaces are considered ‘dirty’ areas. • No standards are currently available that describe operating procedures within dirty areas of the laboratory. Laboratorians must be vigilant in recognizing the potential or risk of transmitting an etiologic agent by touching items in these areas.
The laboratory should establish clear guidelines for the designation of ‘clean’ areas. Uniform, consistent signage should be posted in clean areas and the ‘clean area’ designation should be revoked if the guidelines for working in that area are not followed. The issue of pathologists’ offices and conference rooms comes up for many laboratories. Microscope slides that pathologists are reviewing are usually not considered contaminated if they are fixed slides. If the slides are unfixed the area would be considered contaminated. If the slide trays are clean and slides are fixed, there is less likelihood of contamination. That said, it depends where the offices are and if they are separated from the lab by a closed door.
Guidelines about contaminated versus clean areas should be followed, including the removal of contaminated lab coats before going in to clean areas. If a conference room is deemed to be an uncontaminated area, the same guidelines would apply – removal of contaminated lab coats, closing the door, keeping surfaces free of contamination, and no eating or drinking outside of clean areas. Gloves should not be necessary in any area considered ‘clean’.
Reference:
1. CDC, Guidelines for Safe Work
Practices in Human and Animal
Medical Diagnostic Laboratories, accessed at http://www.cdc. gov/ mmwr/preview/mmwrhtml/ su6101a1.htm
This article was originally published in the Canadian Journal of Medical Laboratory Science (Summer 2013) Vol .75 no. 2. It appears here with permission from the Canadian Society for Medical Laboratory Science (CSMLS). For more information, visit www.csmls.org.
Gene Shematek is Occupational Health and Safety Consultant to Canadian Society for Medical Laboratory Science.
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FEATURE
BY LORENA RUELAS AND JULIE BICK
Mobile Point-of-Diagnostic laboratory:
Extending boundaries through portable flow cytometry
In Canada, citizens benefit from a ‘universal’ health care system as per the Health Care Act. However, it is well documented that not all Canadians have equal access to health services. Aboriginal peoples, in particular, are an underserved group. The National Collaborating Centre for Aboriginal Health addresses the importance of providing better training and recruiting Aboriginal health professionals and the need to emphasize on local control and authority over health care services.1 But up to now the devolution of power to local and regional boards has not necessarily resulted in better health services.2 Being able to empower aboriginal professionals locally while maintaining communication with centralized health boards may be a solution to ease this process of power transfer.
Other factors that affect access to health services in these communities have been identified. Geographic barriers, for example, make health care facilities more dispersed. People requiring specialized health services or diagnostic testing may travel 200 km or more to get to the nearest regional hospital (Browne, 2005).3 Deploying medical services and having a point-of-diagnostic facility near the patient and the sample are vital for an effective response.
In the international arena, infectious disease control is a priority for health organizations. In a report published by the World Health Organization (WHO), damaged public health infrastructure has been identified as one of the main factors that contributed to the undetected spread of the Ebola virus and that impeded rapid containment during last year’s outbreak. The weaknesses in road systems, transport and telecommunication services greatly delayed the conveyance of patients to treatment centres and of samples to laboratories.4 Having rapid access to effective diagnostic tools is critical to the control and monitoring of infectious diseases.
Another factor pointed out by the WHO was the severe shortage of health care workers. Even more disturbing was the unprecedented number of health care workers infected during the outbreaks – nearly 700 from whom more than half had died by the end of 2014.5 Making a mobile lab accessible to remote populations would eliminate the need for infected individuals to travel to central sites, thus significantly reducing the risk of infection spread.
Overall, some of the factors to be taken into account for deploying better health services in remote locations and for a more efficient pandemic response are: • Empowering local teams • Maintaining secure data management and communication with centralized health boards • Having faster access to effective diagnostic tools in the field • Reducing the risk of infection spread
Pennsylvania – has developed a mobile point-of-diagnostic laboratory that can be deployed in remote geographies. It is a completely self-sufficient, fully functional clinical flow cytometry laboratory capable of supporting rapid and sophisticated hematology analytics in the field. The entire mobile laboratory is flow cytometry centered and enables the whole analytics process from sample collection, preparation and analysis up to data management and communication.
Many populations living in remote areas do not carry formal forms of identification. The mobile point-of- diagnostic platform ensures effective patient tracking through a biometric profile. This profile contains the patient’s photo, his/her fingerprints, clinical data and the associated GPS coordinates of the place where the test was made. This enhances surveillance programs for infectious disease spread.
Keeping constant communication with local and international health boards is vital. The communications system of this mobile laboratory can support several platforms: WiFi, Satellite, Cellular or even pointto-point radio. The system can be configured to use one of these as the default platform and connect to another only in case of failure. Hav-
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Empowering local teams
To empower a team, effective tools and training must be provided. In cases requiring fast and effective diagnostics, flow cytometry is the technology of choice. No other laboratory method provides as rapid and detailed analysis of cellular populations as flow cytometry, making it a valuable tool for diagnosis and management of several hematologic and immunologic diseases (Van Laeys, D.).6 The use of flow cytometry in the clinical laboratory has grown substantially in the past decade. This is in part due to the development of smaller, user-friendly, less expensive instruments and a continuous increase in the number of clinical applications.7 Moreover, flow cytometry technology evolution has made it possible to analyze samples easily in the field and within hours of collection.
Having an easy-to-use platform facilitates training and gives the autonomy that local teams need to respond as fast as required. The assays that are used in the mobile laboratory are highly sensitive. Through the monitoring of cell-mediated immune responses to disease-specific antigen they provide clinically actionable data. Besides, they require only two to three drops of capillary blood to reconstitute the reactions. This is a great advantage since there is no need for venous blood draw, which translates into an easier sample collection process with less storage and waste management requirements.
Furthermore, the clinical data is processed using innovative algorithms to generate a go-/no-go decision within minutes of data collection, which definitively empowers non-specialized teams to act fast locally. In addition, all data can be transmitted in real-time to government and health organizations across the globe.
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ing multiple back-up options ensures communication flow. All data can be encrypted for privacy and formatted for compatibility with government agencies such as the Centers for Disease Control and Prevention (CDC). This ensures that real-time data is made available for pandemic response while protecting patient privacy.
For a diagnostic laboratory to be truly mobile and easily deployed in geographies that may have infrastructure constraints, it has to be rugged and with minimal maintenance requirements. This mobile point-of-diagnostic laboratory can be deployed by land or airdropped for rapid placement in even the remotest locations. Therefore, the analytical instrumentation inside not only has to be first in its class, but it also has to be small and sturdy enough to support potential impacts.
The analytical instrument of choice was the portable flow cytometer by handyem – a company established in Québec, Canada- which has all the required characteristics. It uses fibreoptics to guide the light beam from the laser to the small interrogation area to ensure consistent excitation of the cells or particles. The collection fibres are bound in a monolithic assembly resulting in a flow cell which is impervious to vibrations and hence lasers cannot be misaligned. The use of flexible fibre optics also allows for a light and small instrument. In contrast, conventional flow cytometers use free-space optical components that require precise laser beam alignment and add bulk and complexity.
Furthermore, conventional flow cytometers use large volumes of sheath fluid to suspend and hydrodynamically focus cells or particles in a liquid stream as they pass in front of a laser light source. Fibre optics, on the other hand, enable ground-breaking microfluidic flow cell that requires minimal volume of sheath fluid. Low sheath volume requirements ensure that the units can be run without the need for large supplies and that they will not generate high volumes of biomedical waste. This is particularly important when deploying the lab in the field.
Infrastructure constraints in remote locations may cause power outages. Taking this into consideration, the unit comes equipped with different power source options: solar panel, battery, generator and shore power. It also includes a patented converter that ensures no disruptions when converting from one source to another. Besides, the total power consumption of the whole lab –including instrumentation – is 1.5 kW.
Handyem personal cytometer (HPC) inside the Mobile Point-of-Diagnostic (Mo-PODTM)
Reducing the risk of infection spread
The mobile point-of-diagnostic laboratory is equipped with a drone that can be sent near the affected population to bring back samples to be analyzed. The drone is capable of transporting up to 45 lb. of samples and/or supplies. This is a major advantage in two ways: the risk of contamination of health care professionals is reduced and the spread of diseases is better controlled by eliminating the need for infected individuals to travel to central sites.
Moreover, the mobile point-of-diagnostic laboratory has a biosafety cabinet to avoid risk of contamination when preparing the sample i.e. in red blood cell lysis, samples are briefly centrifuged which can create volatiles. Besides, at the end of each working day, the mobile laboratory can be rapidly disinfected to help reduce the risk of disease spread.
Conclusion
Being able to offer better health care to all is a priority for health organizations around the world. The concept of a mobile point-of-diagnostic laboratory is now a reality. Flow cytometry has evolved into a pivotal technology with its use shifting from the hospital core lab facilities to the field. With the implementation of microfluidic systems and the use of optical fibre, innovative and responsive flow cytometry instruments are now turning into a viable point-of-care diagnostic tool. These developments aim at improving patient services, facilitating personalized approaches to medicine as well as supporting effective and powerful pandemic responses. This is truly a mobile solution in health care that has the potential to enhance the way diagnostics are performed in North America and across the globe.
References:
1. National Collaborating Centre for Aboriginal Health. “Access to health services as a social determinant of First Nations, Inuit and Métis health.” Social Determinants of Health. 2011. Web. 21 July, 2015. 2. Browne, Annette. “Issues Affecting Access to Health Services in
Northern, Rural and Remote Regions of Canada.” University of
Northern British Colombia. Aug. 2005. Web. 21 July, 2015. 3. Idem. 4. World Health Organization. “Factors that contributed to undetected spread of the Ebola virus and impeded rapid containment.”
One year into the Ebola epidemic. January 2015. Web. 21 July, 2015. 5. Idem. 6. Van Laeys, Dana L. “Introduction to Flow Cytometry: Blood Cell
Identification.” Media Lab Incorporated. Web. 17 July, 2015 7. Brown, Michael and Carl
Wittwer. “Flow Cytometry: Principles and Clinical Applications in Hematology.” Clinical Chemistry. Vol. 46. No. 8. Aug. 2000: 1221-1229. American Association for Clinical Chemistry. Web. 17 July 2015.
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BY PHILIP HUTCHERSON
FEATURE
Safety & Simplicity in the lab: What to look for in a modern-day centrifuge
As one of the mainstays in any lab, centrifuges are designed to spin and separate liquid and solid components at high speeds. Practically everyone in the lab uses these indispensible tools, so researchers look for models that are safe for multiple users and reliable 24/7. With researchers being inherently busy, laboratories want features that make complex centrifuge applications, easy. Non-stop modern research labs often have multiple users sharing centrifuges, as they do most capital equipment. This environment creates safety issues for lab personnel and can be a source of mishaps and lost samples, if used improperly. Unfortunately, many lab staff are forced to work with antiquated equipment that can potentially lead to accidents and research delays. Technology innovations designed for user safety and simplicity can make centrifuges trouble-free, allowing researchers to work smarter while achieving research success.
Advancing rotors
Recent material technology advances in centrifuge rotor design, rotor exchange technology and rotor identification are now available to simplify centrifuge operation and safety. It is important to understand these new technologies for the safety and research success of the end user.
The basic centrifuge instrument has evolved to a very high level of sophistication due to the increased physical forces on the rotor system and need for interchangeable rotors for application flexibility. Manufacturers make a variety of rotors for a diverse range of tubes and sample containers. Additionally, special purpose rotors are available for a wide array of high throughput sample processing applications, including microplates and rotors specifically designed with liners for the blood banking industry.
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To enhance the performance and safety of the centrifuge, manufacturers are looking at alternatives to metal alloys for rotor construction. Rotors have traditionally been made out of metal, a dense and heavy material that can potentially cause injury to laboratory staff during installation or removal from the centrifuge. However, these metal rotors are not corrosion-resistant and are susceptible to structural changes generated by centrifugal force stresses. Engineers have made significant advances in material technologies for centrifuge rotors, and many developments have been made using carbon fibre composite materials.
Carbon fibre technology
The benefits of carbon fibre rotors bring together the combined properties of lightweight, durability and corrosion resistance that are prized by many industries, such as the automotive and aerospace sectors. First, carbon fibre rotors are lightweight, and have a higher strengthto-weight ratio than most metals. This improved ergonomic feature makes installation and removal easier, reducing the chances of personnel obtaining lower back injuries, thus contributing to a safer work environment. Another limitation of using heavier rotors is the inconvenience of needing the assistance of another person to remove the rotor from the centrifuge or requiring the use of a cart for transport.
Secondly, carbon fibre rotors are corrosion-resistant and as a result, have an increased life span. Exposure to moisture and most organic or chemicals solutions such as alkaline solutions and salts, occurs regularly in laboratory environments. Carbon fibre rotors are more resistant to this type of exposure and are safe for use with most laboratory detergents and commercially available solutions for radioactive decontamination.
Finally, carbon fibre rotors are more durable to ultra-high gravitational centrifuge stresses than alloy metal rotors. These metal rotors are more vulnerable to the tremendous forces and repeated cycles that cause structural damage to the rotor. Advance composite carbon materials are much more resistant to this type of fatigue, and enable a longer lifespan. Also, carbon fibre rotors can accelerate and decelerate faster in the centrifuge, which shortens the run time and increases process efficiency within the lab. This reduces stress on the centrifuge through decreased wear on the drive components, making a carbon To achieve high performance and lab safety when operating a centrifuge, it is also important to establish internal lab policies to avoid damage and costly repair. The first step is to ensure that all lab employees are using established manufacturer procedures for centrifuge safety.
fibre rotor investment longer lasting and more appealing to laboratory budgets.
One centrifuge, many uses
The proper installation of rotors can require considerable strength and technique, something which is compounded by heavier alloy metal rotors. This process often involves a special tool to ensure that the rotors are safely secured in the centrifuge chamber. Loss of sample or, in the worst case, loss of the rotor is rare. However infrequent, rotor system failure from improper installation could damage the centrifuge and injure personnel in the immediate vicinity. Manufacturers have made innovative advances to improve rotor placement and provide users with the confidence that the rotor is safely and securely locked in the centrifuge.
Unlike the traditional rotor tiedown systems, secure rotor exchange technology enables users to install or remove rotors in seconds. These trouble-free rotor exchange systems allow easy access and cleaning convenience, with the flexibility to switch rotors to accommodate many different types of tubes and volumes all within the same centrifuge – saving both time and money on multiple centrifuge purchases. This simple-to-operate system requires the single push of a button to release and remove the rotor, while locking the rotor securely during its run.
Multiple users, maximum security
In a typical lab, there are multiple users for most centrifuges. Modern centrifuges have many built-in features for rotor management that allow end users to monitor usage by rotor serial number, total number of hours used, or total number of cycles. State-of-the-art technologies include; remote monitoring and control, interactive touch screen features with interface for quick-start manuals, operator and run reporting to assist with GMP/GLP compliance, and multilingual instructions for run conditions, alert messages and password protection.
New innovations in instant rotor identification prevent the user from programming wrong rotor speeds and codes. The instant rotor identification feature immediately identifies the rotor when secured in the centrifuge chamber, with rotor specifications automatically loaded into the parameters of the instrument. The process of centrifuge rotor overspeeding can occur if the wrong rotor codes and speeds are accidently entered in the user interface. This user error can prematurely stop a centrifuge run and result in incomplete separation, affecting valuable samples, resulting in loss of run time and causing possible damage to the centrifuge.
Automatic rotor identification technology works by detecting the rotor’s unique magnetic pattern as soon as it is secured into the centrifuge. The rotor name and specifications are then automatically loaded into the centrifuge’s parameters. Immediate identification of a rotor by the programmed centrifuge also reduces the run time set-up and eliminates the need to find and set rotor codes. This feature streamlines the research process and reduces the potential for user error messages by simplifying rotor transfer and protocols.
To further increase efficiency with a shared centrifuge, it is now possible to connect the centrifuge in realtime with a smart device for instant remote monitoring and control. This innovation saves time and hassle by eliminating the hunt for an open instrument; instead users can find an idle centrifuge from the list without leaving an office or lab space. Once a run is set-up, the run can be started from the instrument control panel or, with a secure centrifuge connection, from a smart device. By monitoring the instrument main screen for run status, users learn immediately of diagnostic errors or if a run was stopped prior to completion.
To achieve high performance and lab safety when operating a centrifuge, it is also important to establish internal lab policies to avoid damage and costly repair. The first step is to ensure that all lab employees are using established manufacturer procedures for centrifuge safety. Manufacturers provide user manuals and training on the proper use of the instrument; including software instructions for run logging, data management, on-board tutorial videos and access to codes for multi-users and rotor ID. Centrifuge maintenance requires daily procedures such as a visual check for rotor damage and a regular schedule to clean rotors. These procedures also include specific instructions for decontamination and to minimize aerosol exposure for each model. Almost all centrifuge manufacturers recommend an annual calibration check on the instrument.
Conclusion
A properly functioning centrifuge will provide researchers with consistent and reliable performance while minimizing the probability of an accident. There are many beneficial features to consider for rotor management such as automated systems that instantly detect and regulate parameters based on the rotor installed. With a range of research requirements and high staff turnover, a centrifuge that is easy-to-use and accommodates multiple users with different experience levels will ensure consistency of lab performance, and can now be monitored remotely. Recent advances in carbon fibre rotors, rotor exchange technology and rotor identification have helped to extend the life of your centrifuge, while improving safety and lab performance.
For more information on Thermo Scientific centrifuges and rotors, please visit: www.thermoscientific.com/centrifuges
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