GLOCAREPHARMAMANUFACTURI
NGP.L.
C
ግሎኬርፋርማሲማኑፋክቸሪንግፒ.ኤል.ሲ
H.
[Link]/
Kil
int
oIP,Wer
eda09,SubCi
ty:AkakiKal
it
y,
Addi
sAbaba,
Ethi
opi
[Link]
:+251-
09-
06-06-
66-60
ኤች.
አይ.አዲስ/
ቂሊን
ጦ አይፒ፣ወረዳ09፣ክፍለከተማ አቃቂ
ቃሊቲ፣
አዲስአበባ፣ኢትዮጵያ።ስልክ፡251-
09-
06-
06-
66-
60
STANDARDOPERATI
NGPROCEDURE
መደበኛየአሠራርሂደት
PROCEDUREFOROPERATI
ONANDCLEANI
NGOFRAPIDMIXERGRANULATOR.
የፈጣንማደባለቅግራኑላተርአሰራርእናየማጽዳትሂደት።
SOPNo. : GPM-
SOP-
PRD-TAB-
047-
00
5.
1 OPERATI ONOFRAPI DMI XERGRANULATOR
የፈጣንድብልቅግራኑላተርኦፕሬሽን
5.
1.1 Product i
onper sonshal lensur et hecl eanl
inessoft heGr anulat
or,i
ts
parts,
areaandCLEANEDl abel oni t
.
የምርትሰው የግራኑሌተርንን ፅህናን፣ክፍሎቹን፣
አካባቢእናየጸዳመለያበላዩላይ።
5.
1.2 Remov et heCLEANEDl [Link] ainl i
neclearancefr om QAand
updat ethest atusl abel,
ment ioningt hedet ail
sofPr oductName, BatchNo, Bat chSize,Mfg
Date, Expiry,Act i
vit
yStat us,NextSt ageandCheckedPr oducti
on
Officer/Chemi stDat eandSi gnat ureasperl abel f
[Link]-
QAD- 038- F-
001
የCLEANED መለያውንያስወግዱ።ከ QA የመስመር ማጽጃ ያግኙ እናየሁኔ ታ
መለያውንያዘምኑ፣
የምርትስም፣ባች ቁጥር፣ባች መጠን ፣Mf gቀን ፣ጊዜው የሚያበቃበት፣የተግባር
ሁኔ ታ፣ቀጣይ ደረጃ እና የተረጋገጠ የምርት ኦፊሰር/ የኬሚስትሪ ቀን እና ፊርማ
በመለያው ቅርጸትቁጥርGPM- QAD- 038- F-001በመጥቀስ።
5.
1.3 Opent hecompr essedairv alveandcheckt heairpr essurebetween3-
2
4kg/ cm
የተጨ መቀውንየአየርቫልቭይክፈቱእናየአየርግፊቱንከ3- 4ኪ. ግ/ሴ. ሜ ያረጋግጡ
5.
1.4 Ensur ethatbowl l
idisclosedandl ockedwi ththetoggl eclamp.
Ensur ethatt he
dustcol lectorv entisfi
t t
edwi tht hef il
terproperl
y.
ጎድጓዳሳህኑመዘጋቱንእናበመቀያየርማያያዣመቆለፉንያረጋግጡ።መሆኑን
ያረጋግጡ
Page1of1
የአቧራአሰባሳቢው ቀዳዳበትክክልከማጣሪያው ጋርተስተካክሏል.
5.
1.5 Ensurethatthecl
eanedFBDbowli
splacedbelowthedi
schar
gepor
t
[Link] he
i
ntegri
tyoftheFBDbowl meshbef
oreusingt
hebowl.
የፀዳው የFBDሳህንከአርኤምጂ መውጫ ወደብበታችመቀመጡንያረጋግጡ።
ይመልከቱ
ሳህኑንከመጠቀምዎበፊትየFBDጎድጓዳሳህንትክክለኛነ ት።
5.
1.6 Switchonthemains,.
ForDr
ycy
cle
በአውታረመረቡላይይቀይሩ,
.
ለደረቅዑደት
a)I
mpell
ermotorsl
owsett i
me(min)
የኢምፔለርሞተርዘገምተኛየቅን ብርጊዜ( ደቂቃ)
b)I
mpell
emotorfastsett
ime(min)
ForWetcy
cle
የ
ኢምፔልሞተርፈጣንየዝግጅትጊዜ(
ደቂቃ)
ለእርጥብዑደት
a)Impellermot orslowsett i
me( min)
የ ኢምፔለርሞተርዘገምተኛየቅን ብርጊዜ( ደቂቃ)
b)Impellermot orfastsettime(min)
የ ኢምፔለርሞተርየተወሰነጊዜ( ደቂቃ)
c)Choppermot orslowdel ayti
me( min)
ቾፐርሞተርየዘገየመዘግየትጊዜ( ደቂቃ)
d)Choppermot orslowsett ime(min)
ቾፐርሞተርዘገምተኛየተቀናበረጊዜ( ደቂቃ)
e)Choppermot orfastdelaytime(min)
የ ቾፕርሞተርፈጣንመዘግየትጊዜ( ደቂቃ)
f)Choppermot orfastsett i
me(min)
የ ቾፕርሞተርፈጣንየተቀናበረጊዜ( ደቂቃ)
5.
1.7 Checkfort heproperoperat i
onofthebeater
,chopperanddi
schar
ge
portoftheRMGby
operati
ngt herespecti
vetouchkey sprovi
ded.
የRMGየሚደበድበው፣ቾፐርእናማስወጫ ወደብትክክለኛአሠራርመኖሩን
ያረጋግጡ
የቀረቡትንየን ክኪቁልፎችንመሥራት።
Page2of2
5.
1.8 Switcht hemodeofoper ati
ont omanual .
የአሰራርሂደቱንወደማን ዋልይቀይሩ.
5.
1.9 Opent helidoft heRMGandl oadal ltheshi f
tedmat er i
alsintot he
RMGas
ment ionedi ntheBMR.
የRMGክዳንይክፈቱእናሁሉን ም የተቀየሩቁሳቁሶችንወደRMGእን ደይጫ ኑ
በBMRውስጥ ተጠቅሷል.
5.
1.1 Closet hel i
dpr oper l
yandt ightt hel ocki ngknobs.
0 ሽፋኑንበትክክልይዝጉትእናየመቆለፊያቁልፎችንያጥቡት.
5.
1.1 Nowsett hetimerandt hespeedoft hei mpel lerf ordr ymixingas
1 specifiedi ntheBMR, startmi xi ng, mixerwi l
lbest oppedaf terthe
mixingt imei sov eraut omat i
cal ly .
አሁንለደረቅድብልቅጊዜቆጣሪውንእናየi mpel l
erፍጥነ ትያዘጋጁ
በBMRውስጥ ይገለጻል፣መቀላቀልይጀምሩ፣የማደባለቁጊዜ በራስ- ሰርካለቀ
በኋላቀማሚው ይቆማል።
5.
1.1 Wai tforami nutet oset tl
et hepowder ,proceedf orwetgr anulat i
on.
2 ዱቄቱንለማቆም ለአን ድደቂቃያህልይጠብቁ, እርጥብጥራጥሬንይቀጥሉ.
5.
1.1 Startthemi xi
ngi nsl owspeed, opent hebi nderaddi tionpor t/openthe
3 l
idincaset hebi nderi sthicker ,
addt hebi ndersl owl yundermi xingasspeci fi
edi nt heBMR, change
thespeedt ofasti fr equiredf ort he
[Link] heendpoi ntf orgr anul ati
onbyv isuall
y.
ድብልቁንበቀስታፍጥነ ትይጀምሩ፣ማያያዣው ተጨ ማሪወደብይክፈቱ/ማሰሪያው
ወፍራም ከሆነ፣ክዳኑንይክፈቱ፣
በቢኤምአርውስጥ በተገለፀው መሠረትማሰሪያውንበቀስታበማደባለቅይጨ ምሩ፣
አስፈላጊከሆነፍጥነ ቱንወደፍጥነ ትይለውጡ
granulation.የጥራጥሬውንየመጨ ረሻነ ጥብበእይታያረጋግጡ።
5.
1.1 Oncet hegr anul ationendpoi nti sachi ev ed,st opt heRMG,opent he
4 l
id,checkt hewetgr anulesphy si call
y ,scrapoutt headher edpowder
tothel idandsi desoft heRMG, andcl oset hel i
d.
የጥራጥሬው የመጨ ረሻነ ጥብከደረሰበኋላRMGንያቁሙ ,ክዳኑንይክፈቱ,እርጥብ
የሆኑትንጥራጥሬዎች በአካልይፈትሹ,የተጣበቀውንዱቄትበአርኤምጂው ክዳንእና
ጎኖችላይያስወግዱ እናክዳኑንይዝጉ.
5.
1.1 Runt hei mpel l
eri fr equired( granul ati
onnotachi ev ed) ,compl etethe
5 granulation.
Oncet hegr anulat i
oni scompl et ed, opent hedi schar gepor tand
unloadt hegr anul es
Page3of3
i
nt ocleanFBDbowl placedundert hedi schar
gepor t
.
አስፈላጊከሆነአስመጪ ውንያሂዱ ( ጥራጥሬው አልተሳካም)፣ጥራጥሬውን
ያጠናቅቁ።
ጥራጥሬው ከተጠናቀቀበኋላየመልቀቂያውንወደብይክፈቱእናጥራጥሬዎችን
ያውርዱ
በማፍሰሻወደብስርየተቀመጠ ን ጹህየFBDሳህንውስጥ።
5.
1.1 Opent hel id,
scr apoutal ltheadher edmat eri
alandremov efr
om the
6 RMGand
dischargei nt
ot heFBDbowl .
ክዳኑንይክፈቱ፣ሁሉን ም የተጣበቁትንነ ገሮችያፅዱ እናከRMGያስወግዱት።
ወደFBDሳህንውስጥ መልቀቅ።
5.
1.1 Tr ansfert heFBDbowl l
oadwi t
hwetgr anulestodryi
ng.
7 የFBDሳህንጭ ነ ትበእርጥብጥራጥሬወደማድረቂያያስተላልፉ።
5.
1.1 Updat et hestatusl abel ofRMGasTOBECLEANEDasperf ormat
8 [Link]- QAD-038- F-003.
የRMGየኹናቴመለያእን ደTOBECLEANEDእን ደቅርጸትያዘምኑ
ቁጥርGPM- QAD- 038- F-003.
5.
2 CLEANI NG
ማጽዳት
5.
2.1 CLEANI NG DURI NG PRODUCTTO PRODUCTCHANGEOVER( Type-B
Cleaning)
ለውጥንለማምረትበምርትጊዜማጽዳት( ዓይነ ት-ቢጽዳት)
5.
2.1.
1 Remov ethestat usl abel TOBECLEANED.
ለመጽዳትየሁኔ ታመለያውንያስወግዱ።
5.
2.1.
2 Connectt hemai nsandswi tchONt hemachi ne.
ዋናውንያገናኙእናማሽኑንያብሩ።
5.
2.1.
3 Cl oset heli
dandt hedi schargepor toftheRMG.
የRMGክዳንእናየማስወጫ ወደብዝጋ።
5.
2.1.
4 Fi lltheRMG 1/ 4th wit
hpot ablewat erandoper at
etheRMG f or2
mi nutesi nslow speedt horoughlyt or emovealladheredmat eri
als
from t hemachi ne.
RMG1/ 4ኛንበሚጠጣ ውሃይሙሉእናሁሉን ም የተጣበቁቁሳቁሶችንከማሽኑ
ውስጥ ለማስወገድRMGለ2ደቂቃዎችበዝግታፍጥነ ትበደንብያንቀሳቅሱ።
5.
2.1.
5 Nowwasht hemachineinsi
deandoutsi
dewith0.
1%SLSsolut
ionin
water thor
oughl
y,f ol
l
owed by washi ng wit
h potabl
e water
thor
oughlyt
oremovealltr
acesofSLS.
አሁንማሽኑንከውስጥ እናከውጪ በ0. 1% የኤስኤስኤስመፍትሄበውሃውስጥ
Page4of4
በደን ብ ያጥቡት፣ በመቀጠልም በን ፁህ መጠጥ ውሃበመታጠብ ሁሉን ም የSLS
ምልክቶችያስወግዱ።
5.
2.1.
6 Clean t he wor king platform oft he machi ne with potabl e water
thor oughl y.
የማሽኑንየሥራመድረክበን ፁህመጠጥ ውሃያጽዱ.
5.
2.1.
7 Rinset hemachi neandt hepl atfor
m wi thpur i
fi
edwat ert horoughly
andal lowdr yi
[Link]/r i
nsesampl et obesentt oQCf oranalysis
ofpr eviouspr oduct.
ማሽኑንእናመድረኩንበተጣራውሃበደን ብያጠቡእናማድረቅይፍቀዱ. የቀድሞውን
ምርትለመተን ተንስዋብ/ያለቅልቁናሙናወደQCይላካል.
5.
2.1.
8 Cleant hepanel withcleanl intfreesclothtodr y.
ፓነ ሉንለማድረቅን ጹህከተሸፈነጨ ርቅያጽዱ.
5.
2.1.
9 Cleani nsi
deandout sideoft hemachi newi thdrycl eanl i
ntf r
ee
cloth.
ማሽኑንከውስጥ እናከውጪ በደረቅን ጹህከተሸፈነጨ ርቅያፅዱ።
5.
2.1.
1 Taket hel i
necl earancef orcl eaningfrom QA.
0 ከQAለማፅዳትየመስመርማጽጃውንይውሰዱ።
5.
2.1.
1 Ent ert hecleaningdet ailsint heequipmentl ogbook.
1 የጽዳትዝርዝሮችንበመሳሪያው መዝገብውስጥ ያስገቡ።
5.
2.1.
1 Closet helidandt hedi schar gepor toft hemachi ne,Updat ethe
2 stat usoft hemachi net o CLEANED asperequi pmentcl eani
ng
stat usl [Link]- QAD- 038-F-
004.
ክዳኑንእናየማሽኑንማስወጫ ወደብ ይዝጉ፣የማሽኑንሁኔ ታወደክሊነ ድ ያዘምኑ
እን ደመሳሪያየጽዳትሁኔ ታመለያቅርጸትቁጥርGPM- QAD-038-
F-004።
5.
2.1.
1 Updat et hest atusoft hemachi netoCLEANEDasperequi pment
3 cleani ngst atuslabel
[Link]- QAD-038- F-004.
እን ደመሳሪያየጽዳትሁኔ ታመለያየማሽኑንሁኔ ታወደcl eANEDያዘምኑ
ቅርጸትቁጥርGPM- QAD-038- F-004.
5.
2.2 BATCHTOBATCHCLEANI NG:( TypeACl eaning)
ባችለባችማጽጃ፡( የጽዳትአይነ ት)
5.
2.2.
1 Aft
ercomplet
ionofbatch,remov
eallmat
eri
alsandthedocuments
fr
om thear
ea.
ክምችቱከተጠናቀቀበኋላሁሉን ም እቃዎችእናሰነዶችከአካባቢው ያስወግዱ.
5.
2.2.
2 Scrapoutmat er
ial
sadheredtotheRMG incl
udingthedischar
ge
portusi
ngscr
apper.
ከRMGጋርየተጣበቁቁሳቁሶችንጥራጊንበመጠቀም የመልቀቂያወደቡንጨ ምሮ
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ያስወግዱ።
5.
2.2.
3 Closet hel i
dandt hedi schar
gepor toft hemachi ne,cleant he
outsi
deofmachi neandt hepanelwit
hcl eandryl
intf
reeclot
h.
ክዳኑንእናየማሽኑንማስወጫ ወደብ ይዝጉ ፣የማሽኑንእናየፓነ ሉንውጭ በደረቅ
ከተሸፈነጨ ርቅያፅዱ።
5.
2.2.
4 Updat ethest atusoft hemachinetoCLEANEDasperequi pment
cl
eani ngstatuslabel formatNo.
GPM- QAD- 038-F-004.
የማሽኑንሁኔ ታወደcl eANEDያዘምኑእን ደመሳሪያየጽዳትሁኔ ታመለያቅርጸት
ቁጥር.
ጂፒኤም- QAD- 038- ኤፍ-004.
5.
2.2.
5 Updat etheusageandcl eani
ngdetai
lsintheequipmentlogbookas
perAnnexur eIandpr ocessparametersinBMR.
የአጠቃቀም እናየጽዳትዝርዝሮችንበመሳሪያመዝገብ ደብተርውስጥ እን ደአባሪI
እናበBMRውስጥ መለኪያዎችንያዘምኑ።
5.
2.2.
6 Preventivemai ntenanceofRMGi scarri
edoutMont hly,Quarter
ly&
Yearlyasperpr ev enti
vemai nt
enanceschedule.
በመከላከያጥገናመርሃግብርመሰረትየRMGየመከላከያጥገናበየወሩ,
በየሩብእናበየአመቱይከናወናል.
Pr
epar
edby Rev
iewedby Appr
ovedby
አዘጋጅ የተገመገመው በ ያረጋገጠው ሰው
Name
ስም
Desi
gnat
ion
ስያሜ
Si
gnat
ure
ፊርማ
Dat
e
ቀን
For
matNo:
GPM-
QAD-
001-
F-001-
00
ቅርጸትቁጥር:
GPM-
QAD-
001-
F-001-
00
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