Vacker LL ClPO Box 92438lDubailUAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:[email protected]www.vackerglobal.com DETAILED PROCEDURE AND GUIDELINES ON TEMPERATURE MAPPING STUDY & QUALIFICATION OF COLD ROOMS, WAREHOUSES, VANS, TRUCKS, REEFERS, REFRIGERATORS & BOXES FOR PHARMACEUTICAL INDUSTRYRevision History: Revision no. Date of issue Description 0 16 Nov 2014 Original Issue 1 2 Jan 2015 Sl. No. 3 and subheadings added. Sl. No. 5 and subheadings added. Sl. No. 7 and subheadings added. This document is copy righted to Vacker LLC, Dubai and no part of this document may be reproduced in any form whatsoever without permission from us.
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Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
Vacker UAE has issued these guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans etc. for pharmaceutical and life care segment.
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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
<e/perature /appin5 )tu. an. <e/perature ualification )tu. are carrie. out 5enerall in
phar/aceutical in.u)tr+ <here are .ifferent kin. of /e.icine) an. accine) 1hich nee. to
be )tore. an. tran)porte. at certain te/perature)+ >aorit of the)e /e.icine) an. accine)are un.er t1o cate5orie) iF+ <ho)e to be )tore. bet1een 2 to 8 De5ree *enti5ra.e an.
tho)e to be )tore. bet1een $( to 2(*+
-t i) i/portant for the efficac of the /e.icine that the
)a/e be )tore. an. tran)porte. at the reco//en.e.
te/perature li/it) a) aboe+ -f the /e.icine or accine
5oe) aboe the)e te/perature li/it), the /e.icinal
propertie) 1ill be 5ra.uall lo)t an. /o)t i/portantl
the pro.uct) 1ill not )ho1 an in.ication that it ha)
been co/pro/i)e.+ -n )uch ca)e the ulti/ate .i)tributor
an. u)er 1ill be una1are of the efficac of the /e.icine+
<he )tora5e i) .one in 1arehou)e), col. roo/) or
refri5erator) an. tran)portation i) carrie. out in boxe),
an), reefer) an. container)+
<he 1hole )et of )tu. i) carrie. out to analFe the te/perature .i)tribution in a 1arehou)e,
col. roo/, refri5erator, an or reefer truck) to fin. out 1hether the te/perature in)i.e )uch
facilit i) al1a) /aintaine. bet1een the .e)ire. te/perature+
'ir)tl 1e 1ill explain about te/perature /appin5 )tu. an. thereafter about
te/perature @ hu/i.it .i)tribution+
3.3.3. $02 wol1 2o re5)re Tem/era,re Ma//)+g S,12
6aka Tem/era,re D)*,r)b,)o+ *,1278
-f ou are inole. in /anufacturin5, tran)portation, )tora5e or .i)tribution of /e.icine) an.accine), ou 1ill be intere)te. to kno1 /ore about te/perature /appin5 )tu.+ -n all the)e
ca)e) our /e.icine i) kept in)i.e an enclo)e. area )uch a) a 1arehou)e, col. roo/,
te/perature controlle. an, reefer truck, refri5erator, in)ulate. boxe) etc+
-n )uch ca)e) ou nee. to en)ure that the te/perature in)i.e the enclo)e. area i) 1ithin the
.e)ire. li/it)+ e5+ -f ou 1ant to keep the /e.icine bet1een 2 to 8 * an. ou are keepin5
in)i.e a col. roo/, ho1 .o ou en)ure that all the entire col. roo/ i) bet1een the)e
te/perature li/it)C Hou /i5ht be keepin5 the /e.icine at one )helf in)i.e the col. roo/+ Hou
1ill not hae an i.ea 1hether thi) particular place i) 1ithin the li/it)+ Generall ou 1ill hae
an in.icator connecte. to the coolin5 unit to .i)pla the current te/perature+ <hi) .i)pla
pick) up the te/perature u)t fro/ one )en)or place. at a certain location near the .uct
openin5 of the coolin5 unit, ba)e. on 1hich the coolin5 unit ha) it) )1itch O: an. O'' ccle)+
7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
Prior to co//ence/ent of a te/perature ualification )tu., 1e reuire the follo1in5
.ocu/ent?.etail) fro/ the cu)to/er+
a+ <he cu)to/er ha) to proi.e the laout .ra1in5 of the a))et
b+ All .etail) of coolin5 unit) )uch a) )l+ no)+, .etail) of )en)or), operation /anual), .e)i5n
.ra1in5) etc+ hae to be proi.e.+
c+ i/ilar .etail) of .ehu/i.ifier) al)o hae to be proi.e.+
.+ All .etail) of te/perature /onitorin5 ))te/) !if an% to be proi.e.+
Ba)e. on the)e .ocu/ent) a protocol 1ill be prepare. b u) 1hich ha) to be reie1e. an.
approe. b the cu)to/er+
<he te)t) 1ill be carrie. out b u) ba)e. on thi) protocol+
9.=. Re/or,* o- a Tem/era,re 5al)-)ca,)o+ *,12
<he report) of a te/perature ualification )tu. 1ill
contain the follo1in5 .etail) in 5eneral+ Plea)e note
the)e /a ar .epen.in5 on the nature of the a))et+
a+ De)i5n ualification proce)) K Pa)) or 'ail
b+ -n)tallation ualification proce)) K Pa)) or 'ail
c+ Operation ualification proce)) K Pa)) or 'ail
.+ Docu/ent erification K Pa)) or 'ail
e+ E/pt /appin5 )tu. K Pa)) or 'ail
f+ =oa.e. /appin5 )tu. K Pa)) or 'ail
5+ Po1er failure te)t re)ult)
h+ 6ecoer te)t re)ult)
i+
tart up te)t re)ult) + 7ot an. col. point)
k+ Deiation if an
l+ 6eco//en.ation)
/+ *orrectie action)
-f all the aboe te)t) are pa))e. )ati)factoril .urin5 the te/perature ualification )tu., 1e
i))ue a certificate in.icatin5 that the a))et i) full ualifie.+ <he .etail) of the a))et 1ill be
in.icate. in the certificate+
:. %ow ,o carr2 o, a !al)-)ca,)o+ *,12
<hi) )ection briefl .e)cribe) /etho. of ualification )tu. for certain a))et)+ Hou /a oncea5ain note that a /appin5 )tu. i) part of a ualification )tu.+ But the ualification)
proce)) inole) certain other proce.ure) a) explaine. in preiou) )ection)+
:.3. %ow ,o carr2 o, 5al)-)ca,)o+ o- a bo?
Box i) one )uch ite/ 1hich 1ill reuire a ualification becau)e box 5oe) throu5h .ail tou5h
han.lin5 an. hence a /appin5 )tu. alone 1ill not be )ufficient to te)t it) efficienc+ Al)o
for boxe) 1e reco//en. a )horter ali.it of one ear for a ualification+ A) the box 5oe)
throu5h tou5her con.ition), it i) preferre. to hae the ualification .one once eer ear+
Actie boxe)
'or actie boxe), ualification inclu.e) the follo1in5
7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
lo)t+ E5+ the .i)pla unit /i5ht be )ho1in5 (* an. the .rier 1ill be confi.ent that
the col. cabin i) at (*+ 7o1eer it i) po))ible that the in)i.e te/perature i) at #*+
-n or.er to aoi. )uch a )ituation place a .ata lo55er next to the )en)or of the coolin5
unit an. recor. for fe1 hour)+ et the coolin5 unit at .e)ire. te/perature+ After couple
of hour) .o1nloa. the .ata an. analFe+ <he 5raph 1ill be in continuou) up an. .o1n
ccle)+ *heck the hi5he)t an. lo1e)t te/perature of the)e ccle)+ -f the)e alue) are
clo)e to the )et point, it /ean) that the )en)or an. .i)pla unit are 1orkin5 correctl+
E5+ if the )et point i) (*, the hi5he)t an. lo1e)t rea.in5) )houl. be #* @ 4*+ !<hi)
arie) ba)e. on the tpe of coolin5 unit, pro5ra//e. )ettin5 of upper an. lo1er cut
off li/it) etc+ 7o1eer thi) 1ill 5ie an in.ication about correlation of the .i)plae.
te/perature an. actual )en)or te/perature+
b+ <e/perature 5oe) to extre/e lo1 an. hi5h point) at all ccle)+ E5+ <he )et point i)
(*+ 7o1eer the te/perature 5oe) re5ularl to 9* an. 3* re5ularl+ <hi) happene.
becau)e the coolin5 unit i) pro5ra//e. accor.in5l+ ie+ -t ha) a hi5h cut off at 4*
aboe the )et point an. lo1 cut off of 2* belo1 the )et point+ <hi) can be pro5ra//e.for 2* for both hi5h an. lo1 cut off point)+ <hereafter the hi5her @ lo1er cut off 1ill
be # @ 3* re)pectiel+ !<hi) feature i) ba)e. on the /anufacturer an. /o.el) of the
coolin5 unit%
c+ <e/perature on one en. of the ehicle 5oe) beon. li/it)+ <hi) happen) /ainl in
ehicle) 1hich ha) one coolin5 unit an. hain5 fan onl at one en.+ -t i) po))ible that
the other en. of the col. cabin i) not properl receiin5 the air+ -f the fan unit i) not
pro.ucin5 )tron5 air flo1 it /a happen+ Other1i)e air flo1 .uct) 1ill hae to be
proi.e. fro/ the coolin5 unit to the other en. of the coole. cabin+ <hu) the air 1ill
be .ii.e. throu5h /ultiple .uct) an. .i)tribute. at front an. rear en. of the ehicle+
.+ <e/perature 5oe) hi5h at certain point) .urin5 loa.e. te)t+ <hi) /a happen /ainl
.ue to li/ite. air flo1+ Durin5 a loa.e. te)t !an. .urin5 actual loa.e. con.ition)%,
5oo.) )houl. not be place. .irectl in front of the air flo1+ Al)o )ufficient )pace )houl.
be left on all )i.e) an. on the top for efficient air flo1+
'or 1arehou)e) the /o)t co//on rea)on) for failure are
a+ <he nu/ber of coolin5 unit) or the capacit of the coolin5 unit) /a not be
)ufficient
b+ <he location of the .uct) /a not be proper
c+ 7u/i.it /a be hi5her than .e)ire. leel)
;.;. $0a, )* ,0e val)1),2 /er)o1 o- a ,em/era,re ma//)+g
*,12 a+1 ,em/era,re 5al)-)ca,)o+ *,128
<here are no 5eneral rule) applicable for the )a/e+ 7o1eer for a ne1 facilit 1e )u55e)t
that the )tu. report can be con)i.ere. ali. for a perio. of 3 ear)+
-f an /o.ification) are carrie. out relate. to )hape an. laout of the a))et, /o.ification or
replace/ent of coolin5 unit), rearran5e/ent of rack) etc+, the ori5inal report cannot be
con)i.ere. ali.+ <he rea)onin5 i) that an of the)e chan5e) 1ill affect the .i)tribution of
te/perature an. hu/i.it+
<. Rea*o+* -or -a)lre o- a !al)-)ca,)o+ *,12
Een if a /appin5 )tu. i) )ucce))ful, the ualification /a fail for other rea)on)+
'e1 of the /aor rea)on) are li)te. here+ uch rea)on) are pointe. out a) .eiation)in the report an. /o)t of the /inor .eiation) can be clo)e. after rectification)+
7o1eer )o/eti/e) it /a happen that the .eiation /i5ht be /aor an. /a
reuire /aor rectification) an. rete)tin5 for )ucce))ful ualification+
<.3. Rea*o+* -or -a)lre o- 5al)-)ca,)o+ *,12 o- a va+
>aor rea)on) for failure of a an are
• 'ailure to /aintain proper calibration report)
• *ontrol panel of the coolin5 unit of the an i) not 1orkin5 properl
• <he euip/ent are not in)talle. a) per /anufacturerL) reco//en.ation
•
<he euip/ent are not operate. a) per /anufacturerL) reco//en.ation• <here are no clear 1ritten in)truction) to the operator) for proper
operation of the ehicle
<.9. Rea*o+* -or -a)lre o- 5al)-)ca,)o+ o- a col1 room
>aor rea)on) for failure of a col. roo/ are
• 'ailure to /aintain proper calibration report)
• *ontrol panel of the coolin5 unit inclu.in5 con.en)er, eaporator of the
col. roo/ i) not 1orkin5 properl
• <he euip/ent are not in)talle. a) per /anufacturerL) reco//en.ation
•
<he euip/ent are not operate. a) per /anufacturerL) reco//en.ation
7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
-t i) i.eal that before carrin5 out the actual )tu., ou /a carr out a trial )tu. 1ith fe1nu/ber of .ata lo55er) to analFe the .ata+ <hi) trial )tu. 1ill help ou to ealuate /aor
proble/) if an+ 'or all contract) bein5 un.ertaken b u), 1e carr out a trial )tu. before
co//ence/ent of the actual te)t+ <hi) 1ill )ae aluable ti/e an. /one for the cu)to/er+
=.3. A1va+,age* o- a ,r)al *,12
>aor a.anta5e of con.uctin5 a trial )tu. are
a+ ain5 ti/e an. /one K After con.uctin5 a full te)t ou /a en. up 1ith )o/e
.eiation)+ -n )uch ca)e ou 1ill hae to carr out a rete)t after un.ertakin5 the
correctie action)+ B thi) ti/e ou /a be in the /i.)t of a cli/ate chan5e an. hence1ill hae to 1ait for the next )ea)on+ -f a trial )tu. i) planne. properl, thi) can be
aoi.e.+
b+ *orrect )ettin5) for coolin5 unit) K )o/eti/e) u)t b chan5in5 the )ettin5) of the
coolin5 unit) ou /a hae better re)ult)+ Hou /a not hae notice. thi) )o far
becau)e our current recor.in5 .eice) 1ere not place. at the correct hot an. col.
point)+
c+ 6euire/ent of .ehu/i.ifier K -n /an ca)e) hu/i.it .i)tribution 1a) not properl
analFe. an. hence /a reuire in)tallation of .ehu/i.ifier)+ <hi) i) a proce))
inolin5 ti/e an. /one an. hence if un.er)too. at the proper )ta5e, )uitable action)
can be un.ertaken+
7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans
Before co//encin5 the actual te)t), 1e 1ill )ent ou )o/e .ata lo55er) for placin5 at certain
location) a) per the .ra1in5)+ <he .ata nee. to be collecte. for a certain .uration an. the
.ata lo55er) hae to be returne.+ e 1ill analFe the .ata an. 1ill proi.e )uitablereco//en.ation)+ Generall 1e inclu.e one trial )tu. in our )cope to a))i)t cu)to/er) !<o
Vali.ation i) often confu)e. 1ith ualification an. often u)e. interchan5eabl+ -t
/a not cau)e a proble/ 1hile the ter/) ali.ation i) ualification i) u)e.
interchan5eable+ e hae )een e)peciall the follo1in5 ter/) bein5 u)e.
a+ Vali.ation of boxe) K <hi) i) 5enerall ualification of the boxe) onl unle))
.efine. )eparatel+ -f the .ata lo55er u)e. in the boxe) nee. to be ali.ate.,that i) a )eparate proce.ure an. i) not coere. un.er ualification of the box+
Plea)e )ee ., e @ f un.er thi) )ection for /ore .etail)+
b+ Vali.ation of col. roo/) K <hi) al)o refer to ualification onl+ -f the .ata
lo55er or real ti/e /onitorin5 ))te/ u)e. in the col. roo/ nee. to be
ali.ate., that i) a )eparate proce.ure an. i) not coere. un.er ualification
of the col. roo/+ Plea)e )ee ., e @ f un.er thi) )ection for /ore .etail)+
c+ Vali.ation of an), reefer) etc+ J <hi) al)o refer to ualification onl+ -f the
.ata lo55er or real ti/e /onitorin5 ))te/ u)e. in the ehicle nee. to be
ali.ate., that i) a )eparate proce.ure an. i) not coere. un.er ualification
of the an or reefer+ Plea)e )ee ., e @ f un.er thi) )ection for /ore .etail)+
.+ Vali.ation of real ti/e te/perature /onitorin5 ))te/ K <hi) i) not part of
ualification an. i) .one )eparatel+ -n )i/ple ter/) real ti/e /onitorin5
))te/ con)i)t) of electronic co/ponent), )oft1are, clou. )erer, local )erer
etc+ an. it nee. to be erifie. that all )uch co/ponent) are 1orkin5 correctl
en)urin5 correct recor.in5 an. rea.in5) acro)) all the)e channel)+ Al)o thi)
ha) to /eet *'6 Part $$ )tan.ar.)+ <hi) 1hole proce)) i) kno1n a) ali.ation
of the ))te/+ Once the ))te/ i) ali.ate., ou can be )ure that the
rea.in5) pro.uce. at .ifferent point) of the har.1are an. )oft1are are all
the )a/e+
e+ Vali.ation of a .ata lo55er K <hi) al)o i) in line 1ith l+ . aboe, but
applicable for the .ata lo55er an. it) )oft1aref+ Vali.ation of a )oft1are u)e. to /onitor the ))te/+J <hi) al)o i) in line 1ith
. @ e aboe+ <hi) i) 5enerall applicable for an )oft1are, but in our context
1e are referrin5 to an )oft1are u)e. for /onitorin5 of te/perature or
hu/i.it+ E5+ -f a cu)to/er i) u)in5 .i)po)able .ata lo55er) !or an other
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
@. Docme+,* rela,e1 ,o Ma//)+g *,12 !al)-)ca,)o+
a+ *a)e )tu. of a te/perature ualification )tu. on a col. roo/ http??bit+l?$4(&<(
b+
Protocol ? OP for <e/perature ualification )tu. of col. roo/ http??bit+l?$FH;no c+ Protocol ? OP for <e/perature /appin5 )tu. of 1arehou)e http??bit+l?$Ah2t-
:B 'or ea)e of un.er)tan.in5, 1e 5enerall /entione. about te/perature throu5hout the
article+ 7o1eer all /ention) about <e/perature /appin5 )tu. are euall applicable for
<e/perature @ 7u/i.it /appin5 a) 1ell+ i/ilarl all /ention) of a <e/perature ualification
)tu. are euall applicable for <e/perature @ 7u/i.it ualification )tu.+
Al)o te/perature /appin5 )tu. i) kno1n a) <e/perature .i)tribution anal)i)+