Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects – has completed work on the preparation and commissioning of the manufacturing line for BacterOMIC system components. The production capacity of the line will allow to manufacture cartridges and BacterOMIC analyzers to the extent that is necessary for pre-registration tests. The manufacturing infrastructure in the Company’s factory in Warsaw is also used for the assembly of PCR|ONE system cartridges.
Commissioning of the manufacturing line which allows the assembly of chips (cartridges) and devices (analyzers and fillers) of the BacterOMIC system has been performed according to ISO 13485 guidelines.
The line has been equipped with all devices required in the process, including: a laminar flow cabinet for sterile work with antibiotics; pneumatic presses for bonding the film with the base plate of the cartridge; a station for automated dosing of antibiotics; a device for simultaneous cutting and thermal welding of the film for BacterOMIC syringes; and chambers for clean work fitted with UV lamps for sterilizing cartridge components.
– We completed an important stage of the BacterOMIC project on time, i.e. we created a manufacturing space dedicated for this project with all ISO requirements and standards in place. The developed line will enable us to manufacture the assumed number of systems that will be used for pre-registration tests. We have created an improved version of the device and are ready to move on to the stage of tests required under the certification and registration process – says Seweryn Bajer-Borstyn, PhD, Bacteromic product manager.
The beginning of pre-registration tests that are necessary for the registration and certification of the BacterOMIC system is scheduled for Q4 2020. The analytical part of the test will be carried out in the company’s own laboratory and the clinical evaluation will take place in laboratories dealing with the assessment of microbial susceptibility. Registration and certification of the BacterOMIC system, according to the current schedule, is planned for mid-2021.