guidelines for temperature mapping study and qualification of cold rooms, ware houses,...

19
  Vacker LL C l PO Box 92438 l Dubai l UAE 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 INDUSTRY  Revision 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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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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Page 1: Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

http://slidepdf.com/reader/full/guidelines-for-temperature-mapping-study-and-qualification-of-cold-rooms-ware 1/18

 

 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

DETAILED PROCEDURE ANDGUIDELINES

ON

TEMPERATURE MAPPING

STUDY !UALI"ICATIONO"

COLD ROOMS#$ARE%OUSES# VANS#TRUC&S# REE"ERS#RE"RIGERATORS 'O(ES

"OR

P%ARMACEUTICALINDUSTRY  

6ei)ion 7i)tor

Rev)*)o+ +o. Da,e o- )**e De*cr)/,)o+

$& :o 2$4 Ori5inal -))ue

$ 2 ;an 2$( l+ :o+ 3 an. )ubhea.in5) a..e.+l+ :o+ ( an. )ubhea.in5) a..e.+l+ :o+ # an. )ubhea.in5) a..e.+

T0)* 1ocme+, )* co/2 r)g0,e1 ,o Vacker LLC# Dba) a+1 +o /ar, o- ,0)* 1ocme+, ma2 be

re/ro1ce1 )+ a+2 -orm w0a,*oever w),0o, /erm)**)o+ -rom *.

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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

<AB=E O' *O:<E:<

$+  <e/perature >appin5 tu. ? <e/perature @ 7u/i.it >appin5 )tu. +++++++++++++++++++++++++++++ 3 

$+$+$+  h 1oul. ou reuire <e/perature >appin5 tu. !aka <e/perature Di)tribution

)tu.%C 3 

$+$+2+  7o1 .o 1e carr out te/perature /appin5 )tu.C +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 4 

$+2+  hat i) te/perature an. hu/i.it /appin5 )tu.C ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 4 

$+2+$+  Do ou reuire a te/perature /appin5 or te/perature @ hu/i.it /appin5C ++++++++++++++++++++ 4 

$+2+2+  hat i) the reco//en.e. hu/i.it leel for )tora5e of /e.icine)C ++++++++++++++++++++++++++++++++++ ( 

$+2+3+ 

7o1 to re.uce the hu/i.it for col. roo/) an. 1arehou)e) for /e.icine )tora5eC ++++++++++++ ( 

$+3+ 

Docu/entation reuire. prior to co//ence/ent of a /appin5 )tu. ++++++++++++++++++++++++++++++++ ( 

$+4+   Acceptance criteria for the /appin5 )tu.C ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ & 

$+(+  7o1 to .eci.e the )a/plin5 interal of .ata collection for the /appin5 )tu. ++++++++++++++++++++ & 

$+&+  7o1 to u)e the re)ult) of te/perature /appin5 )tu. ++++++++++++++++++++++++++++++++++++++++++++++++++++++ # 

$+#+  <e/perature /appin5 )tu. ? <e/perature @ 7u/i.it /appin5 )tu. for ariou) a))et) ++ # 

$+#+$+  <e/perature /appin5 )tu. of 6eefer truck) @ an) ++++++++++++++++++++++++++++++++++++++++++++++++++++++++ # 

$+#+2+  <e/perature /appin5 )tu. of a 1are hou)e ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ # 

$+#+3+  <e/perature /appin5 )tu. of *ol. roo/ +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 8 

$+#+4+ 

<e/perature /appin5 )tu. of a refri5erator +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 8 

$+#+(+  <e/perature /appin5 )tu. of a )hippin5 box +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 8 

$+8+  6eport) 5enerate. in <e/perature >appin5 )tu. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ 8 

2+ 

hat i) <e/perature ualification )tu.C !or <e/perature @ 7u/i.it ualification )tu.% 9 

2+$+  Difference bet1een <e/perature /appin5 )tu. an. <e/perature ualification )tu. +++++++ 9 

2+2+  7o1 to .eci.e 1hether ou nee. <e/perature >appin5 )tu. or <e/perature ualification

tu.C $ 

2+3+  Do ou reuire a <e/perature ualification )tu. or <e/perature an. hu/i.it

ualificationC +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $ 

2+4+ 

 A.anta5e) of a <e/perature ualification )tu. oer a /appin5 )tu. ++++++++++++++++++++++++++ $ 

2+(+  Docu/entation reuire. prior to co//ence/ent of a ualification proce)) +++++++++++++++++++++ $ 

2+&+  6eport) of a <e/perature ualification )tu. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $$ 

3+  7o1 to carr out a ualification )tu. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $$ 

3+$+  7o1 to carr out ualification of a box ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $$ 

3+2+  7o1 to carr out ualification of a *ol. 6oo/ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $2 

3+3+  7o1 to carr out ualification of a Van or reefer ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $2 

4+ 

6ea)on) for failure of a >appin5 )tu. ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $2 

4+$+  6ea)on) for failure of /appin5 )tu. of a an ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $2 

4+2+  6ea)on) for failure of /appin5 )tu. of a col. roo/ ++++++++++++++++++++++++++++++++++++++++++++++++++++++ $3 

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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

4+3+  6ea)on) for failure of /appin5 )tu. of a are hou)e +++++++++++++++++++++++++++++++++++++++++++++++++++ $3 

4+4+  hat i) the ali.it perio. of a te/perature /appin5 )tu. an. te/perature ualification

)tu.C $4 

(+ 

6ea)on) for failure of a ualification )tu. ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $4 

(+$+  6ea)on) for failure of ualification )tu. of a an +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $4 

(+2+  6ea)on) for failure of ualification of a col. roo/ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $4 

(+3+  6ea)on) for failure of ualification of a pa))ie box ++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $( 

(+4+  6ea)on) for failure of ualification of an actie box ++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $( 

&+  7o1 to i/proe the re)ult) of the te)t an. eli/inate chance) of failureC +++++++++++++++++++++++++ $( 

&+$+   A.anta5e) of a trial )tu. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $( 

&+2+  7o1 to carr out a trial )tu.C ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ $& 

#+  hat i) Vali.ationC hat i) .ifference fro/ ualificationC ++++++++++++++++++++++++++++++++++++++++++++++ $& 

8+ 

Docu/ent) relate. to >appin5 )tu. @ ualification ++++++++++++++++++++++++++++++++++++++++++++++++++++++ $# 

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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

<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+

3. 

Tem/era,re Ma//)+g S,12 4 Tem/era,re %m)1),2 Ma//)+g*,12

<hi) article brief about /appin5 )tu. for <e/perature @ 7u/i.it

3.3. Tem/era,re Ma//)+g S,12 4 Tem/era,re 1)*,r)b,)o+ a+al2*)*

'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)+

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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

<hi) /i5ht be in.icatin5 a te/perature bet1een 2 an. 8 *+ >o)t of u) ten. to beliee that

thi) .i)plae. te/perature i) the te/perature acro)) the entire col. roo/+

7o1eer ho1 about ariou) )hele) an. corner) of the

col. roo/ 1here ou are keepin5 our /e.icine) 1hichare far a1a fro/ thi) particular )en)orC

7o1 .oe) a thir. part like an au.itor can check 1hether

the entire col. roo/ i) un.er correct te/peratureC

7o1 can ou en)ure that the .i)pla at the front .oor i)

exact in relation 1ith the corre)pon.in5 )en)orC

7o1 .o ou kno1 about the ariation) 1hen a .oor i)

opene.C <he )en)or /i5ht be far a1a fro/ the .oor an. hence /a not reflect an ariation+

7o1eer it reall happen) that the area near the .oor )u..enl 5oe) aboe 8*+

 All the)e .oubt) can be clarifie. onl throu5h a te/perature /appin5 )tu.+

3.3.9. %ow 1o we carr2 o, ,em/era,re ma//)+g *,128

-n principle a te/perature /appin5 )tu. inole) recor.in5 the te/perature of the col.

co/part/ent un.er ariou) con.ition)+ <he .ata 1ill be recor.e. for .a) or 1eek) a) per

the nature of the a))et+ :u/erou) te/perature .ata lo55er) 1ill be place. in)i.e the te)tin5

area at ariou) hei5ht) an. .ata 1ill be continuou)l recor.e.+ Depen.in5 on the nature of

the propert, the follo1in5 con.ition) 1ill be te)te.

a+  <e)tin5 un.er e/pt con.ition) to analFe the .i)tribution of te/perature 1hen there

are no loa.) in the area+b+  <e)tin5 un.er &I loa.e. con.ition to analFe the .i)tribution 1hen the area i) loa.e.

up to &I of full capacit+

c+  <e)tin5 un.er $I loa.e. con.ition to analFe the .i)tribution 1hen the area i)

loa.e. in full capacit+

.+  Door openin5 te)t to un.er)tan. the effect) on te/perature .urin5 an. after a .oor

openin5+

e+  Po1er failure te)t to analFe the effect) in the eent of a po1er failure+

f+  tartup te)t to check the ti/e reuire. for )tabiliFin5 of the te/perature in)i.e the

area+

5+  6ecoer te)t to check the ti/e taken for te/perature recoer after a .oor openin5+

3.9.  $0a, )* ,em/era,re a+1 0m)1),2 ma//)+g *,128

<he /etho.olo5 i) )a/e a) a te/perature /appin5 )tu.+ 7o1eer in thi) ca)e hu/i.it

al)o 1ill be recor.e. for the )a/e .uration an. 1ill be analFe.+ -f there are .ehu/i.ifier)

alrea. in)talle., the )ettin5) of the )a/e al)o 1ill be recor.e. to co/pare a5ain)t the actual

re)ult)+ :o1a.a) for /an of the )tora5e area), hu/i.it al)o i) i/portant an. hence nee.

to be inclu.e. in the )tu.+

3.9.3. Do 2o re5)re a ,em/era,re ma//)+g or ,em/era,re

0m)1),2 ma//)+g8

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7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

 A) /entione. earlier, thi) nee. to be .eci.e. b the /anufacturer of the /e.icine) or a) per

our internal ualit polic+ 'or a 1arehou)e, 5enerall it

i) preferre. that hu/i.it al)o be inclu.e. in the )tu.

becau)e a 1arehou)e i) .irectl affecte. b the external

a/bient con.ition)+ 'or a col. roo/ the hu/i.it can 5o

to extre/e hi5h leel) of up to $I becau)e of it)

nature of operation+ Generall the .oor of the col. roo/

open) to a 1arehou)e 1hich i) at a hi5her te/perature+

ince the col. roo/ i) at a lo1er te/perature, it 1ill

attract the /oi)ture an. hence 1ill al1a) hae a hi5her

hu/i.it+ 7ence irre)pectie of the /e.icine bein5 kept

in the col. roo/, it i) i.eal that the col. roo/ be analFe. for hu/i.it a) 1ell+ 7o1eer thi)

can be .eci.e. b ou an. our phar/a /anufacturer+

e reco//en. that for 1arehou)e) an. col. roo/) te/perature an. hu/i.it /appin5 )tu.

nee. to be carrie. out+ 'or an), reefer), refri5erator) an. boxe), onl te/perature /appin5

)tu. /i5ht be )ufficient unle)) other1i)e )pecifie.+

3.9.9. $0a, )* ,0e recomme+1e1 0m)1),2 level -or *,orage o-

me1)c)+e*8

<hi) 5enerall .epen.) on the tpe of /e.icine an. the packa5in5 bein5 kept in the )tora5e

area either for col. roo/ or 1arehou)e+ 7ence thi) i) 5enerall reco//en.e. b the /e.icine

/anufacturer)+ Generall /o)t of the /anufacturer) are reco//en.in5 that the hu/i.it

)houl. be /aintaine. un.er a /axi/u/ li/it of &(I un.er all con.ition)+

3.9.:. 

%ow ,o re1ce ,0e 0m)1),2 -or col1 room* a+1ware0o*e* -or me1)c)+e *,orage8

7u/i.it can be re.uce. /ainl utiliFin5 .ehu/i.ifier)+

<he)e are electrical .eice) 1hich ab)orb hu/i.it fro/

the air an. conert it into 1ater+ <he 1ater thu) extracte.

can be re/oe. either /anuall or auto/aticall+ -n the

auto/atic /etho. there i) a 1ater pu/p attache. to the

.ehu/i.ifier 1hich 1ill pu/p the 1ater to an external

outlet+ -n the /anual /etho. the 1ater 5et) fille. up in

a tr un.erneath an. ha) to be /anuall .raine.

perio.icall+

-n or.er to .eci.e the nu/ber an. tpe .ehu/i.ifier), )pecial calculation) nee. to be carrie.

out con)i.erin5 the pre)ent te/perature, hu/i.it, .e)ire. hu/i.it etc+

Generall for 1are hou)e), .e)iccant tpe an. for col. roo/), rotar tpe .ehu/i.ifier) hae

to be u)e.+

3.:.  Docme+,a,)o+ re5)re1 /r)or ,o comme+ceme+, o- a

ma//)+g *,12

<he cu)to/er ha) to proi.e the laout .ra1in5 of the a))et inclu.in5 .etail) an. location) of

coolin5 unit) an. .ehu/i.ifier) if an+

Page 7: Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

7/17/2019 Guidelines for temperature mapping study and qualification of cold rooms, ware houses, refrigerators, vans

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

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 prior to co//ence/ent of the

te/perature /appin5 )tu.+

3.;.   Acce/,a+ce cr),er)a -or ,0e ma//)+g *,128

<he re)ult) of the .i)tribution )tu. 1ill be either pa)) or fail+ Al)o it can be fail or pa)) 1ith

)o/e .eiation)+ <he criteria for acceptance of the )tu. 1ill be .efine. in the protocol an.

tpical one) are a) un.er

a+   All rea.in5) of the .ata lo55er) )houl. be 1ithin the .e)ire. li/it) of te/perature @

hu/i.it

b+ 

>ean 0inetic alue )houl. be 1ithin .e)ire. li/it) !e .o not encoura5e thi) criteria

unle)) in)i)te. b the client+ 7o1eer 1e 1ill in.icate the alue in our report)%

c+  Durin5 .oor openin5 te)t), the alue) )houl. be 1ithin li/it) an. )houl. return to

nor/alc 1ithin the .e)ire. .uration a) .efine. in the protocol+

3.<.  %ow ,o 1ec)1e ,0e *am/l)+g )+,erval o- 1a,a collec,)o+

-or ,0e ma//)+g *,12

a/plin5 interal i) the freuenc of .ata recor.in5 of

the .ata lo55er)+ Generall the .ata lo55er) can bepro5ra//e. to recor. the .ata at .ifferent interal) )uch

a) $)econ.), 3 )econ.), $ /inute etc+ -f the )a/plin5

interal of a te/perature .ata lo55er i) pro5ra//e. for

( /inute) it /ean) that the te/perature i) recor.e.

eer ( /inute)+

a/plin5 interal of .ata collection )houl. be kept i.eall

a) follo1) for a te/perature /appin5 )tu.

a+  3 /inute) for 2J8 * a))et) )uch a) col. roo/), ehicle), boxe), refri5erator) etc+

b+  ( /inute) for $(J2(* ehicle)+

c+  $J$( /inute) for 1arehou)e) /aintaine. at $(J2( *

<hi) i) /ainl ba)e. on the 5oo.) to be )tore. in)i.e the a))et+ E5+ -f a /e.icine 1hich )houl.

not 5o aboe 8* for 2 /inute) i) )tore. in)i.e a refri5erator, it /ean) that ou )houl. keep

a )a/plin5 interal of at lea)t $ /inute+ 'or a /e.icine 1hich i) per/itte. to 5o aboe 8*

for $ /inute), a )a/plin5 interal of 3 /inute) i) )ufficient+

<hi) al)o .epen.) on the ran5e of the te/perature+ 2J8 * i) a er narro1 ran5e an. can 5o

aboe thi) ran5e een for /inor fluctuation)+ 7ence i.eall a )a/plin5 interal )houl. not be

/ore than 3 /inute)+

'or a 1arehou)e, $(J2( * i) a 1i.er ran5e an. the ri)e in te/perature 1ill be )lo1+ 7ence a)a/plin5 interal of $ /inute) i) )ufficient+

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

3.=.  %ow ,o *e ,0e re*l,* o- ,em/era,re ma//)+g *,12

'ro/ the )u//ar of the report) of a te/perature /appin5 )tu., the follo1in5 .etail) 1ill

be u)eful for our practical application)

$+  hen ou .eci.e to place /onitorin5 .eice) )uch

a) .ata lo55er) or real ti/e /onitorin5 .eice),

tho)e )houl. be place. in 7ot an. col. point)+ 7ot

an. col. point) 1ill be /entione. in our report)+

2+  <he report 1ill in.icate the .uration 1ithin 1hich

the te/perature 1ill excee. the per/itte. leel)

upon .oor openin5+ e5+ if )uch .uration i) (

/inute), ou )houl. take care that the .oor

openin5 )houl. be for a er )hort .uration+

3+ 

<he report 1ill in.icate the .uration 1ithin 1hich

the te/perature 1ill excee. the per/itte. leel)

in the eent of po1er failure+ o in ca)e of a po1er failure, ou )houl. not open the

.oor an. )houl. be in clo)e. con.ition if ou expect that po1er 1ill be re)tore. 1ithin

)uch a .uration+ -f ou .o not expect po1er re)toration 1ithin )uch a .uration the

/e.icine) )houl. be )hifte. to an alternate facilit )uch a) a te/perature controlle.

an or reefer+

3.>.  Tem/era,re ma//)+g *,12 4 Tem/era,re %m)1),2

ma//)+g *,12 -or var)o* a**e,*

Brief .etail) of the )tu. for ariou) kin. of a))et) are .etaile. hereun.er

3.>.3. Tem/era,re ma//)+g *,12 o- Ree-er ,rck* va+*

'or all tpe of ehicle), pri/aril the follo1in5 te)t) are carrie. out

a+  Di)tribution anal)i) un.er e/pt con.ition) !24 hour)%

b+  Di)tribution anal)i) un.er &I loa.e. con.ition) !24 hour)%

c+  Di)tribution anal)i) un.er full loa. con.ition) !24 hour)%

.+ 

Po1er failure te)te+  Door openin5 te)t

<he percenta5e loa.in5 can be .eci.e. b the client a) per hi) u)ual loa.in5 pattern+

3.>.9. Tem/era,re ma//)+g *,12 o- a ware 0o*e

'or a 1arehou)e the follo1in5 te)t) are carrie. out a) part of a te/perature /appin5 )tu.

a+  <e/perature an. hu/i.it .i)tribution anal)i) i) carrie. out un.er loa.e. con.ition)+

b+  Door openin5 te)t) to analFe the effect)

'or an exi)tin5 1arehou)e it 1ill be .ifficult to carr out other te)t) )uch a) e/pt te)t, po1er

failure te)t etc+ )ince it /a be .ifficult to re/oe the exi)tin5 5oo.) for/ the 1arehou)e+ 'or

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

a 1arehou)e the .i)tribution anal)i) i) carrie. tpicall for #J$4 .a)+ <he te)t) )houl. al)o

inclu.e holi.a) )o that the pattern) can be analFe.+

a/plin5 interal of .ata collection )houl. be kept i.eall at $J$( /inute)+

3.>.:. 

Tem/era,re ma//)+g *,12 o- Col1 room

'or all tpe of col. roo/), pri/aril the follo1in5 te)t)

are carrie. out

a+  Di)tribution anal)i) un.er e/pt con.ition) !24

hour)%

b+  Di)tribution anal)i) un.er &I loa.e. con.ition)

!24 hour)%

c+  Di)tribution anal)i) un.er full loa. con.ition) !24

hour)%

.+ 

Po1er failure te)te+  Door openin5 te)t

<he percenta5e loa.in5 can be .eci.e. b the client a) per hi) u)ual loa.in5 pattern+ a/plin5

interal 1ill be 5enerall kept at 3 /inute)+ 

3.>.;. Tem/era,re ma//)+g *,12 o- a re-r)gera,or

'or refri5erator), pri/aril the follo1in5 te)t) are carrie. out

a+  Di)tribution anal)i) un.er e/pt con.ition) !24 hour)%

b+  Di)tribution anal)i) un.er &I loa.e. con.ition) !24 hour)%

c+ 

Po1er failure te)t.+  Door openin5 te)t !for .ifferent .uration) )uch a) & )econ.), $2 )econ.), $8

)econ.) etc+, )ince for a refri5erator the .oor openin5 1ill be /ore freuent co/pare.

to other a))et)%

<he percenta5e loa.in5 can be .eci.e. b the client a) per hi) u)ual loa.in5 pattern+ a/plin5

interal 1ill be 5enerall kept at $J2 /inute)+ 

3.>.<. Tem/era,re ma//)+g *,12 o- a *0)//)+g bo?

'or )hippin5 box, the follo1in5 te)t) are carrie. out

a+  Di)tribution anal)i) un.er e/pt con.ition) !24 hour)%

b+  Di)tribution anal)i) un.er &I loa.e. con.ition) !24 hour)%

c+  Po1er failure te)t !for actie coolin5 boxe)%

.+  Door openin5 te)t

e+  'or actie boxe), the te)t) 1ill be con.ucte. in)i.e a an a) 1ell a) in)i.e a 1arehou)e

<he percenta5e loa.in5 can be .eci.e. b the client a) per hi) u)ual loa.in5 pattern+ a/plin5

interal 1ill be 5enerall kept at 3 /inute)+ 

3.@.  Re/or,* ge+era,e1 )+ Tem/era,re Ma//)+g *,12

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

<he report) of a /appin5 )tu. 1ill inclu.e the follo1in5 .etail)

a+  <e/perature .i)tribution K Pa)) ?'ail

b+  7u/i.it .i)tribution K Pa)) ?'ail

c+ 

7ot an. col. point) of the a))et+ <he)e 1ill be thehotte)t an. col.e)t point) of the area+ Data

lo55er) nee. to be place. in the)e area)

.+   Analtical 5raph) for all the te)t)

e+   An reco//en.ation) for i/proe/ent

f+  <i/e taken to reach the .e)ire. te/perature after

)tart up

5+  Duration for 1hich the te/perature re/ain)

1ithin the li/it) after a po1er failure

h+  Duration 1ithin 1hich the te/perature excee.) the li/it) .urin5 a .oor openin5

9.  $0a, )* Tem/era,re !al)-)ca,)o+ *,128 6or Tem/era,re

%m)1),2 !al)-)ca,)o+ *,127

<e/perature ualification )tu. i) a er .etaile. )euence of te)t) an. anal)i) to en)ure

that the a))et i) .e)i5ne. an. in)talle. in )uch a 1a that it i) capable of /aintainin5 the

.e)ire. te/perature+ After the)e )erie) of te)t an. erification the a))et i) certifie. to be

ualifie. for achiein5 an. /aintainin5 the .e)ire. leel) of te/perature an. hu/i.it leel)+

<he ariou) te)t) coere. un.er the ualification proce)) in 5eneral are a) un.er

a+  De)i5n ualification proce)) K to erif the euip/ent are .e)i5ne. to 5enerate the

.e)ire. te/perature an. hu/i.it con.ition)

b+  -n)tallation ualification proce)) K <o erif 1hether the in)tallation i) carrie. out a)

per the .e)i5n an. a) per the in)tallation proce.ure) reco//en.e. b the re)pectie

/anufacturer) of critical euip/ent+

c+  Operation ualification proce)) K <o erif that the operation) are carrie. out a) per

the reco//en.e. proce.ure) of the /anufacturer) of the critical euip/ent

.+  Docu/ent erification K <o erif 1hether all .ocu/ent) are /aintaine. b the u)er

inclu.in5 OP, calibration certificate) etc+

e+  <e/perature /appin5 )tu. !an. 7u/i.it if reuire.% K <hi) te)t i) /ore or le)) )a/e

a) .efine. in the fir)t part of thi) article+

9.3.  D)--ere+ce be,wee+ Tem/era,re ma//)+g *,12 a+1

Tem/era,re 5al)-)ca,)o+ *,12

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

-n a te/perature /appin5 )tu., onl .i)tribution of

te/perature @ hu/i.it are analFe.+ <hi) )tu. /ake)

)ure that the .i)tribution i) al1a) 1ithin the per/itte.ran5e of te/perature an. hu/i.it a) applicable+ 7o1eer

the /appin5 )tu. .oe) not check ariou) criteria )uch a)

OP, 1hether in)tallation ha) been .one correctl,

1hether the /achine) are 1orkin5 a) per the .e)i5n,

1hether 1ritten proce.ure) are /aintaine., 1hether

the)e 1ritten proce.ure) are )ufficient etc+ All )uch

para/eter) are coere. in a te/perature ualification

)tu.+

 A te/perature ualification )tu. incu.e) /appin5 )tu., but not ice er)a+

9.9.  %ow ,o 1ec)1e w0e,0er 2o +ee1 Tem/era,re Ma//)+g

*,12 or Tem/era,re !al)-)ca,)o+ S,128

-f ou 1ant to check onl .i)tribution of te/perature @ hu/i.it, a /appin5 )tu. i) )ufficient+

-f ou 1ant to check 1hether the 1hole a))et i) .e)i5ne., in)talle. an. operate. correctl, it

i) .e)irable to carr out a te/perature ualification )tu.+

 A ualification )tu. i) con)i.ere. to /ore of international acceptance+ An au.itor fro/

another part of the 1orl. /a not be fa/iliar 1ith ariou) in)tallation an. operational

para/eter) of the a))et+ -f an a))et i) ualifie. the a))et i) con)i.ere. to be a full )ati)factor

))te/+

9.:.  Do 2o re5)re a Tem/era,re 5al)-)ca,)o+ *,12 or

Tem/era,re a+1 0m)1),2 5al)-)ca,)o+8

Plea)e )ee our explanation for )i/ilar uer un.er te/perature /appin5 )tu.+

-f our /aor para/eter i) onl te/perature, the ou /a li/it to a te/perature ualification

)tu.+ -f ou al)o reuire hu/i.it, a te/perature @ hu/i.it ualification )tu. 1ill be

reuire.+

9.;. 

 A1va+,age* o- a Tem/era,re 5al)-)ca,)o+ *,12 over ama//)+g *,12

<he te/perature ualification )tu. i) con)i.ere. /ore of international acceptance+ o if our

client) an. )upplier) are fro/ ariou) countrie) it i) preferre. to hae a ualification proce))

.one+ A) an exa/ple each countr ha) their o1n tpe of .e)i5n, in)tallation an. operation

proce.ure) for a col. roo/+ 7ence our client fro/ another countr /a not be fa/iliar 1ith

)uch para/eter) in our countr+ -f a te/perature ualification )tu. i) carrie. out on thi)

col. roo/, the client nee. not check an .etail) at all )ince the col. roo/ i) full ualifie. to

en)ure full co/pliance to keep a te/perature bet1een 2J8*

9.<.  Docme+,a,)o+ re5)re1 /r)or ,o comme+ceme+, o- a

5al)-)ca,)o+ /roce**

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

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

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

•  Define a <her/al profile ba)e. on 5eneral operatin5 con.ition)

•  <e)t the box a5ain)t thi) ther/al profile

•  *heck in)tallation an. operation of the coolin5 unit)

•   Verif the calibration of the )en)or) an. the coolin5 unit)

Pa))ie box

'or pa))ie boxe), there are not /a te)t) co/pare. to actie boxe)+

'or pa))ie boxe), 5enerall ualification nee. to be .one onl on a )a/ple piece an. not

on eer box+ E)peciall there are /an tpe) of )in5le u)e pa))ie boxe) an. hence one

fro/ each .e)i5n nee. to be ualifie. to proe the efficienc of the box+

-n or.er to carr out the )tu. /ore efficientl, it i) .e)irable to kno1 the operatin5

eniron/ent con.ition) that the box un.er5oe) for each cu)to/er+

:.9.  %ow ,o carr2 o, 5al)-)ca,)o+ o- a Col1 Room

'or a col. roo/, the follo1in5 erification) nee. to be .one+

•   Verif the calibration recor.)

•  *heck the in)tallation of the coolin5 unit), )en)or), location of )en)or)

•  *heck entire operation of the coolin5 unit), control panel an. a))ociate.

circuitrie)

•  *heck the /aintenance proce.ure) of the coolin5 unit)

:.:.  %ow ,o carr2 o, 5al)-)ca,)o+ o- a Va+ or ree-er

'or a an or reefer, the follo1in5 erification) nee. to be .one+

•   Verif the calibration recor.)

•  *heck the in)tallation of the coolin5 unit), )en)or), location of )en)or)

•  *heck entire operation of the coolin5 unit), control panel an. a))ociate.

circuitrie)

•  *heck the /aintenance proce.ure) of the coolin5 unit)

;. 

Rea*o+* -or -a)lre o- a Ma//)+g *,12*o//on rea)on) for failure of a te/perature /appin5 )tu. or a hu/i.it /appin5 )tu.

are li)te. here

;.3.  Rea*o+* -or -a)lre o- ma//)+g *,12 o- a va+

e are /entionin5 of )/all an. /e.iu/ )iFe. an)+ <here are /an rea)on) for failure of

the)e ehicle) .urin5 a te/perature /appin5 )tu. an. te/perature ualification+ <he /ain

one) are li)te. here

a+  <he te/perature )ho1n in the .i)pla unit of the coolin5 unit /a not be /atchin5

1ith actual in)i.e te/perature+ Probabl the )en)or i) rea.in5 i) not correct+ <hi) can

happen for /an rea)on)+ Oer a perio. of ti/e the accurac of the )en)or /a be

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Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

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+

;.9.  Rea*o+* -or -a)lre o- ma//)+g *,12 o- a col1 room

General rea)on) for failure of a col. roo/ are a) un.er

<he .i)pla unit fixe. at the out)i.e of the col. roo/ /a not be .i)plain5 the correct

te/perature of the col. roo/+

<he loa.in5 an. .i)tribution of the )hele) /a not be unifor/ thu) hin.erin5 properairflo1

7u/i.it /a be hi5her than the per/itte. leel)

<he po)itionin5 of the coolin5 unit) /a not be in perfect location thu) affectin5

unifor/ .i)tribution

 Air curtain) /a be reuire. at the .oor)

;.:.  Rea*o+* -or -a)lre o- ma//)+g *,12 o- a $are 0o*e

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

'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

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

•  <here are no clear 1ritten in)truction) to the operator) for proper

operation of the ehicle

<.:. 

Rea*o+* -or -a)lre o- 5al)-)ca,)o+ o- a /a**)ve bo?

>aor rea)on) for failure of a pa))ie box are

•  Proper 1ritten proce.ure) are not aailable for in)truction) of operation

•  Proper i.entification inclu.in5 )erial nu/ber) are not aailable

<.;.  Rea*o+* -or -a)lre o- 5al)-)ca,)o+ o- a+ ac,)ve bo?

>aor rea)on) for failure of a pa))ie box 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 operate. a) per /anufacturerL) reco//en.ation

•  <here are no clear 1ritten in)truction) to the operator) for proper

operation of the ehicle

=.  %ow ,o )m/rove ,0e re*l,* o- ,0e ,e*, a+1 el)m)+a,e c0a+ce* o-

-a)lre8

-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+

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 Vacker LLC  l PO Box 92438 l Dubai l  UAE Part of VackerGlobal Group

Phone !"9#$% 4 2 && $$ 44 l 'ax !"9#$% 4 2 && $$ (( Our office) UAE !*orp+ Office%, -n.ia, O/an , 0u1ait, UA

e/ail)ale)+uaeacker5lobal+co/ www.vackerglobal.com 

=.9.  %ow ,o carr2 o, a ,r)al *,128

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

be finaliFe. at the ti/e of finaliFin5 the or.er%

>.  $0a, )* Val)1a,)o+8 $0a, )* 1)--ere+ce -rom !al)-)ca,)o+8

 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

.ata lo55er)% re5ularl, the report i) 5enerate. u)in5 it) )oft1are+ <he

)oft1are i) in)talle. in a co/puter+ :o1 ho1 .o 1e kno1 a) a u)er that the

)oft1are i) correctl pro.ucin5 all report) fro/ the .ata lo55erC -f there i) an

error in the )oft1are, the rea.in5) an. report) 1ill not be correct+ -f the

)oft1are i) ali.ate., 1e can be )ure that the report) are $I correct+ -n

thi) i) a oneti/e proce.ure for the )oft1are, until a /aor rei)ion i) carrie.out+

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 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)+

Co/2r)g0, T0)* 1ocme+, )* co/2 r)g0,e1 ,o Vacker LLC# Dba) a+1 +o /ar, o- ,0)*

1ocme+, ma2 be re/ro1ce1 )+ a+2 -orm w0a,*oever w),0o, /erm)**)o+ -rom *.