BS 6349-1-4-2021 Packaging for terminally-sterilized medical devices一Method for determination of methylene blue particulate penetration

BS 6349-1-4-2021 Packaging for terminally-sterilized medical devices一Method for determination of methylene blue particulate penetration. 5.7 Air drier. 6 Procedure 6.1 Preliminary 6.1.1 FIll the aloniiaer with a 1% methylene blue tohitloei up tos level 6mm below that of tie. spray orificr’ .appto,uenately 500 ml of solution are required. 6.1.2 After a ,nasimum of 8 Ii operation, discard the swihylene blur wiutsin and replace with a fresh 1% solution of mdhylrelr blue, iecm’ The enmhykoer War eiluoem a, the ammiwr with the staada’d nonk Is ce,eeiunied or. sets of appsUalelte(p te tilt per ileskr no Ian a due in pan to 55. aslmsaatwni tire sok.Ii,a teen in pun Its the ,n.rperonson ofww,avfreeee She ,naiee Sulk of the liquid The cmo,,ntn,tr.e, of lie. ee*tmo in dir ‘,.e.’vow tterev!ewr wrrwaw, cieedn diemg tie, aperture, of the rpparosis The oaf were of tier rowrwir it cheets its thee tile chin we C rranow .p,d low of sete,ee, of the etlvboee d.rie a p.nid ofH S neperothee or teas w4 ow mew an upprrc,abr ci,anpe e the coeern,trntlon of the tt cloud 6.2 Start.up instructions 6.2.1 Start up the apparatus as follows. a) Turn die control cock (C) to OFF b) Swetde on the suntkrn psimp c) Close and clamp the unloaded test piece holder (T). d) Clamp die unloaded test paper holder (F) firmly dosed. e) Turn the control cock (C) to TRST 1) Adjust the .nr valve (V,) to glues flow of 30 dm’fmin through the bypais circuit. g) Turn the control cock (C) to OFF h) Adlusi control valve (Vi) to giv, a flow of 30 dm’/min through the test circuit. i) Turn on the compressed air to the ,itomeaer and adlu;t the needle value (V1) until the pressure gauge (D) registers 205 kPa TIe. ball in th. compressed air flowmeuer CM1) theneeld now rise to the calibration mark. If tie. air flow is InsLeliecient. turn oil the compressed air seed dear the atoenhser )ets. 0Th I Steps 4 C,, 5) .,eqhl&i She nominal air e.ti, wtrm9, Caiw tile req em,d flow nets, I. n.bseqornt .prvItons Wires, o4mtmrots aetly fete, Show uetiqs meter mode. ,107g2 fordetaiisofneainlve,aewr, wOeuuil 6,22 Man theaarpressaareatacoastantof2O5kPa.Theairpressureasnotwbe&ncreasediobringthe air lle,w up to the correct value. 6.3 Preparation of standard stains Prepare the standard stains as follows. a) Close and clamp the unloaded test piece holder. h) Clamp a short piece of biter paper he the test paper holder c) Turn...