life sciences
28
Issue 2 2021
New Forma Cryomed controlled rate freezer offers repeatable performance
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he new Forma CryoMed 2.0 controlled-rate freezer (CRF) from Thermo Scientific, which is supplied locally by Labotec, is ideal for customers in research, cell and gene therapy, vaccine production and biobanking who need repeatable freezing capabilities at a controlled rate. The CryoMed CRF provides repeatable and consistent temperature performance, a touch screen user interface, and customisable freezing profiles while supporting 21 CFR part 11 requirements. Its user-friendly operation with enhanced data traceability and intuitive touchscreen display allows for easy set-up, operation and review of a freezing run. The reliable temperature performance for high throughput usage is made possible through dual solenoid valves designed to balance LN2 injection volume for precise temperature control and accelerated freezing. The consistent temperature control and uniformity is achieved via an air-handling system and liquid nitrogen injection ring and environmentally friendly insulating foam. The units are made from type 304 stainless steel with exterior powder-coat
The oxygen delivery device is simple, efficient, portable and cost-effective
finish, which is compatible with VHP cleaning techniques. Forma CryoMed 2.0 has real-time run monitoring for sample protection using Type T thermocouples that eliminate lag time and provide “real time” responsiveness. A standard alarm will alert users of any thermocouple failures, heater malfunction, high/low temperature limits, temperature tracking, power failure, and completion of run. Remote alarm is possible and there is an optional thermal printer. Some other features include: • Six pre-set freezing profiles and space for up to 14 user-defined, “custom” freeze profiles • Integrated touchscreen UI logs usage and events to support 21 CFR part 11 requirements • User security: 3 levels of user accessibility • USB data export of pdf file run logs support 21 CFR part 11 • “Run last” feature allows the same profile to be run consecutively with the touch of a button • PC interface software provides remote operation capabilities, run review and custom profile creation.
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
Innovation in the air
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s South African healthcare workers struggle to contain COVID-19, some hope is at hand with the formal licencing approval of a simple, efficient, portable and cost-effective device that delivers consistently high levels of oxygen to COVID-19 patients and helps keep their lungs from collapsing. This proudly South African invention could be a game changer where there are a large number of COVID-19 patients yet a lack of skilled staff, ICU and high care facilities; and insufficient bulk oxygen supplies. It effectively bridges the gap between current standard oxygen therapy via face masks and ICU-based non-invasive or mechanical ventilation, while requiring no more oxygen flow than a standard face mask. The device was developed by a group of East London-based volunteers that includes doctors, engineers and entrepreneurs, who set up a social enterprise named Umoya. The South African Health Products Regulatory Authority (SAHPRA) granted Section 21 approval for emergency use only on 21 December 2020. The device will be manufactured and distributed by Gabler Medical. The device’s key components are an anaesthetic mask and an adjustable mechanical valve, known as a positive end respiratory pressure (PEEP) valve. Oxygen supply is via a hose and accumulator bag, with the hose connected to any available oxygen source. A viral filter removes viral particles from expired air, which is a safety benefit for health practitioners using the device.
ISO13485 certification: Reiner Gabler, MD of long-established Gabler Medical, which will manufacture and distribute the device, with the unit The device has been used successfully in environments ranging from rural clinics to specialist hospitals, and by all levels of staff. Medical personnel who have seen and tested the device have been impressed by its simplicity of use, oxygen efficiency and clinical effectiveness. The device will be manufactured, distributed and supported by Gabler Medical, which holds ISO13485 certification and specialises in the manufacture of oxygen therapy equipment.
JHB: (021) 531 0820 info@gablermedical.com https://umoya.org.za
