EN14683 Certification Successful
Update on Commissioning
Remote Monitored Systems plc (“RMS” or the “Company”) announces that further to the announcement on 18 January 2021, Pharm 2 Farm Ltd (“P2F”) has today received the report from Eurofins confirming that the P2F mask has now been certified as meeting the EN14683 standard having passed the biocompatibility test. The EN14683 standard comes on top of the ISO18184 certificate announced in November 2020 and, once in production, the mask can now be sold in the UK and Europe as a viricidal Type IIR mask.
To achieve the EN14683 standard, the mask had to pass five tests, as follows:
Bacterial Filtration Efficiency (BFE): this tests the filtration capacity of the mask. The P2F product achieved a 98.77%; higher than the 98% required and close to the 99% needed for FFP3 respirator.
Differential Pressure: this tests the breathability of the mask. The maximum limit to obtain Type IIR is <60pa/cm2. The P2F mask achieved 46.4pa/cm2 which provides a good balance of breathability and BFE.
Splash resistance: this tests the resistance of the mask to penetration by blood fluid at 16kPa. It is the only required for Type IIR (differentiating it from Type II) as this type of mask can be used in a surgical setting. The key to passing the test is to have a hydrophobic outer layer on the mask. 100% of the masks in P2F sample passed this test compared to the minimum 90% pass rate requirement.
Microbiological cleanliness: this measures the quantity of microorganisms on the mask, effectively, checking the cleanliness of the manufacturing environment. The P2F masks passed, coming in below the maximum permitted measure of 30 cfu/g (Note: CFU is a microbiological measure for the number of viable cells in a sample).
Biocompatibility test: this tests the reaction to human skin – cytotoxicity, irritation and sensitization. The tests which included a biological evaluation and in-vitro cytotoxicity were performed to evaluate the effects of limited (less than 24 hours) and cumulative prolonged use of the mask (from 24hrs to 30 days). The P2F mask performed very well against the controls in all cases and hence are considered to be not cytotoxic and not irritative.
Commissioning of the machine at BioCity, Nottingham, commenced this week but is taking longer than anticipated, as parts have been delayed in transport from Spain, and will extend into early next week, pushing back the start of production and reducing the number of masks that can be produced before the end of January.
The Company looks forward to providing further updates in due course.
Antony Legge, Chairman, said: “Achieving the EN14683 standard is a great step forward as this was a key factor for potential customers and the sales effort can now begin in earnest. The delay in commissioning, caused by customs and transport difficulties in Europe, has been very frustrating but it now should be just a matter of a few days to complete the work.”
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