DESIG N QUALIFICATION PRO TOCOL No.

:
FOR
HVAC BMS
PHARMA DEVILS

DESIGN QUALIFICATION

FOR

HVAC BMS
 DESIG N QUALIFICATION PRO TOCOL No.:
FOR
HVAC BMS
PHARMA DEVILS

PRE -APPROVAL PAGE

DESIG N QUALIFICATION

DOCUMENT N o: … … … … …

“HVAC BMS”

REPORT FOR APPROVAL

(…………………..)

Name Design ation Depart ment Signature Date

REPORT APPROVAL FO R EXECUTIO N

(………………….. .)

Name Design ation Depart ment Signature Date

 DESIG N QUALIFICATION PRO TOCOL No.:
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HVAC BMS
PHARMA DEVILS

TABLE O F CONTENT

Index Description Page No.

1. Int roduct ion 4
2. Summar y S heet 5
3. User Requirement Specificat ion 5
4. Object ive and Scope o f t he wo rk 8
4.1 Scope o f Work 9
4.2 Requirement s For Enviro nment and Operat ion 10
5. Scheme & S yst em Descr ipt io n and Design 12
5.1 S yst em Descr ipt io n: HVAC BMS 12
5.2 Operat ion o f BMS 13
5.3 HVAC BMS Soft ware 14
6. Module Specificat ion 15
7. Validat io n and o t her Cont rol Test ing Measures 16
8. 8.1 HVAC BMS Soft ware cat alogue 16
8.2 Module's pro minent feat ures 16
8.3 Appendix 18
9. Fina l Report 19
10. Design Qualificat ion Report Approval 20
11. Glossar y & Abbreviat io ns 21
 DESIG N QUALIFICATION PRO TOCOL No.:
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1. INTRODUCTION:

Description of Docu ment:

This document provides Document ed evidence for HVAC BMS supplied b y

…………… t o …………… t his syst e m will provide facilit y mo nit or ing at
……………..

The Scope of Design Qualificat io n document is to ensure t hat HVAC BMS

meet s t he des ir ed specificat ions as requir ed.

2. SUMMARY SHEET:

Descr ipt ion o f Equipment : HVAC BMS

Scope Covered B y S yst em:
 Wir ed Cont rol panels
 CFM,RH and Temperat ure sensors
 Displa y P anel Wit h inbuilt Alar m I ndicat ion
 HVAC BMS so ft ware
 Cont rolling & Mo nit or ing o f Temperat ure, Humidit y and CFM

3. USER REQUIREMENT S PECIFICATION (URS) :

3.1 PARAMETERS TO BE MONITORED ( FOR RES PECTIVE AHU’ s):

S.No. Parameters Limit a s per Design Remark
1. CFM CFM is Based on Delt a P Dig it al out put
2. Temperat ure -40 to +125 °C wit h 2 decima l Dig it al out put
point
3. Relat ive Humidit y 0 to 100% wit h 2 decimal po int Dig it al out put
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3.2 USER PO INT DETAILS: (14 AHU’s & Area s)
Device Serial No. Location Detai ls Device Connected
ID No.
1. --- - DDC Contr oller
2. --- - DDC Contr oller
3. --- - DDC Contr oller
4. --- - DDC Contr oller
5. --- - DDC Contr oller
6. --- - DDC Contr oller
7. --- - DDC Contr oller
8. --- - DDC Contr oller
9. --- - DDC Contr oller
10. --- - DDC Contr oller
11. --- - DDC Contr oller
12. --- - DDC Contr oller
13. --- - DDC Contr oller
14. --- - DDC Contr oller
15. T ool R oom Room T RH D evice
16. Dis inf ectant Pr epar ation Room T RH D evice
17. Filtr ation Room T RH D evice
18. Unloa ding Ar ea Room T RH D evice
19. Amp ou le F illing & Sealing Room T RH D evice
20. Ster ile C or r idor Room T RH D evice
21. Dis inf ectant Pr epar ation Room T RH D evice
22. Manufactur ing ar ea Room T RH D evice
23. Unit Pr epar ation Room T RH D evice
24. RM Day Stor e Room T RH D evice
25. PM Day Stor e Room T RH D evice
26. Amp ou le Washing & St er ilization Room T RH D evice
27. Amp ou le H old & Bu ff er Z one Room T RH D evice
28. SPARE Room T RH D evice
29. Panel -01 Room Diff. Pr essur e
30. Panel -01 Room Diff. Pr essur e
31. Panel -01 Room Diff. Pr essur e
32. Panel -01 Room Diff. Pr essur e
33. Panel -01 Room Diff. Pr essur e
34. Panel -01 Room Diff. Pr essur e
35. Panel -01 Room Diff. Pr essur e
36. Panel -02 Room Diff. Pr essur e
 DESIG N QUALIFICATION PRO TOCOL No.:
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Device Serial No. Location Detai ls Device Connected
ID No.
37. Panel -02 Room Diff. Pr essur e
38. Panel -02 Room Diff. Pr essur e
39. Panel -02 Room Diff. Pr essur e
40. Panel -02 Room Diff. Pr essur e
41. Panel -02 Room Diff. Pr essur e
42. Panel -03 Room Diff. Pr essur e
43. Panel -03 Room Diff. Pr essur e
44. Panel -03 Room Diff. Pr essur e
45. Panel -03 Room Diff. Pr essur e
46. Panel -03 Room Diff. Pr essur e
47. Panel -03 Room Diff. Pr essur e
48. Panel -03 Room Diff. Pr essur e
49. Panel -04 Room Diff. Pr essur e
50. Panel -04 Room Diff. Pr essur e
51. Panel -04 Room Diff. Pr essur e
52. Panel -04 Room Diff. Pr essur e
53. Panel -04 Room Diff. Pr essur e
54. Panel -04 Room Diff. Pr essur e
55. Panel -04 Room Diff. Pr essur e
56. Panel -04 Room Diff. Pr essur e
57. Panel -05 Room Diff. Pr essur e
58. Panel -05 Room Diff. Pr essur e
59. Panel -05 Room Diff. Pr essur e
60. Panel -05 Room Diff. Pr essur e
61. Spar e Room Diff. Pr essur e
62. Spar e Room Diff. Pr essur e
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 THIS ABOVE PARAMETERS PERFORMANCE IS SUBJECT TO FO LLOWING:

Inst ruct ions as ment ioned in S yst em P er for mance Warrant y are fo llowed.
 Prevent ive ma int enance should be carr ied out as per requirement .
 Process Areas are o perat ed as per given defined paramet er s and limit s for
HVAC S yst em.
 Cont inues ups power supply t o all t he modules.

4. OBJECTIVE AND SCO PE OF TH E WORK

 Pu rpose:
The purpose of t his document is t o st at e t he necessit ies o f H VAC BMS at
………….. Descr ipt ions are given in t er ms o f gener al funct ions, procedure and
capacit y. Requir ement s are defined as paragraphs t o fac il it at e DQ, IQ, OQ and
PQ. The document is made by, ………….. Purpose of t his document is t o provide
det ailed Technica l infor mat io n of suppl ied syst em. I f required by ………………
will support to ident ify/r eso lve t he proble m

4.1 SCOPE O F WORK :

 Description:

The HVAC BMS is designed for continuous dat a logging, monit or ing and
cont rolling o f defined Paramet ers (Temperat ure, Humid it y, CF M).
 Proper document at ion, including SOP ’s and per iodical report s of all logs
and alar ms and excursio ns. ( All So ft ware relat ed alar ms are as per process
relat ed alar ms limit s (As per defined SOP ).
 Process area and AHU have t o be equipped wit h mult iple sensors spread
evenly t hroughout t he cont rolled area .
 Cont inuous recording of dat a wit h accurac y o f 21 CFR part 11
Co mpliance support ed by Audit t rail and hist or y report .
 Aut o Correct ive act ion t aken, when defined set paramet ers go out side t he
spec ificat io ns.
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 Alarms and Excu rsion s

HVAC BMS is designed wit h ident ificat io n o f abnor malit y which is as belo w
ment io ned.

 St art Alar ming, if mo nit ored values go out side a predefined value.
 Proposed adequat e cont rolled out put fro m cont roller s to achieve
paramet ers(Temper at ure ,Humidit y , CFM)
 Alar ms on excur sio n co ndit io ns being breach ed (usually a set t emperat ure ,
Humidit y and different ial pressur e for a part icular t ime)
 Reco ver y o f Alar ms and Acknowledg ment wit h act ion t aken.

 Scope of work

Scope of work includes:

 Supply o f Tot al syst em according t o specificat ion

 Inst allat io n o f Modules having
₪ CFM sensor (Based on ΔP) (fact ory calibrat ed) wit h digit al out put
₪ Different ial Pressur e sensor (fact ory calibrat ed) wit h digit al out put
₪ Temperat ure sensor (fact ory calibr at ed) wit h digit al out put .
₪ Relat ive Humidit y sensor (fact ory calibrat ed) wit h digit al out put.
 Inst allat io n, St art -Up and per for mance t est at ………………. Sit e.
 Document at ion (DQ, IQ and support to OQ & PQ)
 Training shall be given t o all t he co ncer n persons

4.2 REQUIREMENTS FOR ENVIRONM ENT AND OPERATIO N :

Layout:

The HVAC BMS shall be inst alled at concer ned end for displa y & mo nit ored by
Aut hor ised perso n online.
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Physical condition s & Area classi fication:

S yst em is int ended for indoor applicat ion. For AHU’s CFM, Temperat ure and
Humidit y needs t o be monit ored and maint ained.

UTILITIES:

Ut ilit y r equirement s ar e for t he efficient operat ion o f environment Mo nit or ing .

Utilities Description Remark

Personal co mput er , Int el Core i5 Processor, User ’s scope
For dat a logging & 16 GB RAM Minimum,
mo nit or ing Ubunt u OS, 1TB Hard
Dr ive, USB support
Pr int er Any pr int er. User ’s scope
Power 230 V, 1-phase, 50 Hz. User ’s scope
Cont inues ups power
supply
User All t he user list w it h Name and in
E mail ids ascending for m.

5. SCHEME & SYSTEM DESCRIPTIO N & DESIGN

5.1 SYSTEM DESCRIPTION: HVAC BMS

The H VAC BMS enco mpasses st at e-of-t he-art t echno logy wit h t he visio n o f
mo nit or ing and cont ro lling AHU paramet ers wit hin t he Concord environment
where accurat e t emperat ure, humid it y and CFM mo nit or ing and co nt rolling
are essent ial. HVAC BMS supplied by ………….. having fo llo wing basic
co mponent s:
 Our modules in Ms powder Coat ed Control pane l wit h necessar y co nt rol
out put s , supply and CFM , Temperat ure ,Humidit y Sensors and Real-
t ime D ispla y Conso le wit h Alert Indicat ions
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 Co mmunicat ion card for PC
 HVAC BMS so ft ware
Distinctive Featu res
 Dat a monit or ing, logging and not ificat ion using cent ral base receiver.
 The I nt ernet - and web-enabled remot e diagnost ics and maint enance
 Cont rolled access to HVAC BMS soft ware based on allocat ed user
pr ivileges.
 Displa y current t emperat ure ,humidit y , CFM Init iat es alar m as per defined
paramet er limit s for each par amet ers
 Real t ime mo nit or ing, logging and report ing.
 Best - in- class dat a analys is t ools, includ ing abil it y t o graph and report in
st andard and user -defined for mat s.
 Wir ed module co nnect ions t o t he cent ral comput er syst em.
 Modules are scalable and easy t o int egrat e for fast t ime -t o -market
applicat io ns.

5.2 OPERATION OF HVAC BMS:

The HVAC BMS con sist modu le, base d on recei ver and cent rali zed main
computer with -HVAC BMS so ft ware.

Each individual modu le is fu lly expandable t o meet cust om requirement o f

mo nit or ing and cont rolling based on different AHU ’s applicat io n and
spec ificat io ns.
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modules ( nodes) can be connect ed in mult ip les wit h wire t o a cent ral
mo nit or ing, logging and configurat ion syst em operat ing on a ser ver, facilit y
mo nit or ing syst em co mbines effic ient mo nit or ing and cont rolling wit h effect ive
alar ming, simplified report ing and secure dat a records & st orage.

5.3 HVAC BMS SOFTWARE:

Ser ies is t he online Monit or ing syst e m wit h H VAC BMS soft ware support
which uses t he ver y la t est t echno logy t o fully aut omat e t emperat ure, Relat ive
Humidit y and Pressure monit or ing and recording 24/7 providing effect ive
cont rol over different paramet ers.
Produ cts has designed and developed t he HVAC BMS software t hat shows a l l
paramet er values on t he P C mo nit or screen and keep updat ing and st oring t he m
in t he co mput er as per preset t ime int er vals.
It generat es log report on bases o f t ime, dat e and year t hat can be seen in
graphs, t abular report s in PDF for m. Dat a is st ored as per pre -define d t ime
int er val. Report s are of event s based likewise gener at ed errors, modified set
values of par amet ers, email not ificat ions, et c . The so ft ware is easy t o use and
enables real t ime display, mimic chart , immediat e visual disp lay o f dat a (current
and hist orical) in graphical and pr int able for m.
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The HVAC BMS software, provided wit h all product s, allow s to set paramet er
values, t ake an act io n in correspond t o out of range va lue o f enviro nment a l
paramet ers t hen generat e cont rol out put as per t he algor it hms.
HVAC BMS software exhibit current , minimu m and maximum r ange o f al l
paramet ers and act ivat es a set t able high/ low alar m for each paramet er . I f
paramet ers go high or low, it gives alar m indicat io ns

6. MODULE SPECIFICATIO NS:

 Body: Ms powder Coat ed Panels

 Dimens io ns: 820 mm x 771 mm x 220.22 mm
 Weight : 50 Kg Approx.
Common featu re for Differential Pressu re, Temperatu re and RH sen sor:

 Dig it al signal qualit y

 Fast response t ime
 Insensit ivit y t o ext ernal dist ur bances
 Overall t emperat ure accuracy is ± 0.5 °C
 T iny size and ult r a low power consumpt io n
 Highest reliabilit y and excellent long t erm st abilit y.
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Accu racy at different Temperatu re:

 ±0.5°C, range 0°C t o +40°C
 ±1.0°C range +40 to +70°C
 ±1.5°C range + 70 t o 100°C

Accu racy at different Di fferential Pressure:

 ±0.15, range -345 to +345 Pascal

Accu racy at different R elative Humidity :

 ± 3.0 % RH, RH range 0 to 90 %

 ± 3.5 % RH, RH range 0 to 10 %
 ± 3.5 % RH, RH range 90 t o 100%

 DISPATCH:

All Fact ory manufact ured inst rument s will be cleaned ins ide and out side and
dr ie d befor e packing for dispat ch. All end connect io ns shall be sealed befor e
packing for dispat ch.

 CALIBRATION:

All inst rument s will be provided wit h Factory Calibrat io n sensors and
Will be in co mpliance t o EQDC Cert ificat e.

7. VALIDATION AND O THER CO NTROL TES TING MEASURES:

 INSTALLATION CH ECK :

An inst allat io n checklist shall be per for med befor e I nst allat io n Qualificat ion t o
ensure t hat t he all inst rument s have been inst alled so t hat IQ can be per for med
successfully.
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8.1 HVAC BMS Software catalogue

HVAC BMS Software is being des igned to combine regulat ory demands and
indust r ies nor ms for AHU facilit y. S yst e m is t he o n- line Monit or ing syst em wit h
HVAC BMS soft ware support which uses t he ver y lat est t echno logy t o full y
aut omat e process var iables such as t emper at ure, relat ive humid it y and pressure.

Accu rat e Monitoring :

HVAC BMS offers a large array o f cho ices for monit or ing t he Process area.
Wit h t he use of HVAC BMS.

 Infor mat io n can be mo nit ored locally, cent rally and remot ely.
 Access t o t he syst em is prot ect ed. Each user is assigned wit h user name
and password to gain access t o funct ionalit y, defined by t heir access
level.
 P lant infor mat io n is super vised t hrough st andard and cust om displa ys and
inc ludes:
 Real T ime Display

 Dat a collect ed fro m ever y modu le are linked t oget her and displa yed as
t rends using online and hist or ical t rending wit hin t he syst em. Trended
dat a are available in var iou s groups (Temperat ure, Humidit y. & CFM.)
The mo nit or ing facilit y also provides t he user wit h access to st andard feat ures
of t he s yst em according t o t heir access level, inc luding:
 Trends
 Alar m set point configurat io n
 Cont rol paramet er configur at ion
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Data Logging, alarming and rep orting :

Dat a logging is a ke y requirement for HVAC BMS. 21 CFR P art 11 requires t hat
logged dat a will be t amper proof subject to NDA t his includes cr it ical facilit y
paramet ers (t emper at ure, humidit y, CFM, and et c.), wit h audit t rails inc luding:

 Accurat e t ime and dat e st amps

 Alar ms and event s
 User act ions and det ails (e.g. set point changes as per defined Level o f user
level) (User Levels are administ rat or,supervisor,operator)
 User not es
 Login/ Logout /Auto Timeout Sessio n

T ypically a syst em co mpr ises o f a number of dist r ibut ed modules where module
has it s own int er nal clock. T ime synchro nizat ion is included t o ensure accurat e
t ime and dat e st amps, as requir ed by 21 CFR Part 11, to a known clock source.

The HVAC BMS syst em o ffers facilit y such t hat one can copy dat a
elect ronically for archive and export t hem t o commo n packages (e.g. PDF) for
viewing o f secure records in human readable for mat .

Alarms and Events Rep orting :

A key feat ure of t he HVAC BMS is it s Alar ms and E vent s funct ionalit y. All
alar ms and event s are t ime st amped and lo gged for long t erm ret ent ion and
In co mp liance t o 21 CFR Part s 11. Individual plant dat a can be configur ed t o
have one or a combinat ion o f t he fo llow ing alar ms:
 Cr it ical Alar m select io n and set po int settings wit h t he appropr iat e user access
level.
 Alar m acknowledgement s are aut omat ically logged as requir ed by 21 CFR part s
11.
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 All alar ms and event s are report ed and displa yed in t he Alar m Summar y
report .
 Audible alar m not ificat io n
 Local pr int ing o f alar ms and event s .

Easy to Use, Comp reh ensive Reportin g :

The HVAC BMS syst em pro vides a co mprehens ive review and report ing syst em.
The syst em o ffer s t wo met hods for co llect ing dat a
 Local dat a collect ion – Dat a collect ed lo cally in a secur e for mat and
archived cent rally in a filing syst em
 Cent ral dat a co llect ion – Dat a co llect ed in a cent ral ser ver

In t his wa y, t he HVAC BMS provides t he facilit y t o creat e report s for

individual rooms. Infor mat ion gat hered can be aut omat ically t ransferred and
accessed fro m user s define OS
 Real-t ime and hist or ical t rends
 Mult iple dat a plot s
 Trend analys is

 St andard and cust om quer ies

 Quick report generat ion wit h st andard t emplat es

Easy to Operate at every Level:

Secu rity Manager: Secur it y Manager offer s significant operat ion cost savings
and ease o f use by allowing maint enance of user account s and passwords fro m
one or mult iple lo cat ions. I f a user needs to change t heir password t hey can do
so on a local inst rument or PC and t his will be aut o mat ically dist r ibut ed across
all syst ems t o which t he y have access.
 Change in o ne place, deplo y t o many
 Support for mult iple secur it y zones
 Built - in audit t rail for 21 CFR Part 11
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Remote Monitoring:

Wit h t he use of HVAC BMS; remot e users, including o ff- sit e, can access plant
infor mat io n via a secure web port al.
 Remot e real-t ime dat a visualizat io n
 Support for mult iple w indows
 Int egrat ed infor mat io n fro m diverse dat a sources

Validation:

A key requir ement for HVAC BMS solut io ns is va lidat io n. Where facilit y
cond it io ns (e.g. t emperat ure, humid it y, cfm et c) have a dir ect impact on product
pur it y, safet y, qualit y or effic iency t hey need t o be mo nit ored against
predet er mined limit s and logged. I n t his case t he syst em used for co llect ing and
logging t he dat a needs t o be validat ed.

8.2 Module's p romin ent featu res

 CFM, Pressure, Temperat ure and RH. Measurement s in one.

 Big LCD display for local display o f mo nitored values.
 Provides 100% guarant ee o f validat ion dat a deliver y using fact or y
calibrat ed measurement sensor s.
 High and low alar m for upper and lower limit
 Dr y co nt act or so lid st at e alar m out put (O ptional)
 Alar m out put can be used for simp le ON/ OFF co nt rol
 Visua l and Audible alar m not ificat ion for operator att ent ion
 User programmable display int er val
 Real-t ime clock(O ptional)
 Individual or cent ralized module dat a pr int ing
 Ser ial co mmunicat ion
 Hard wir ed / wir eless co mmunicat ion
 Pot ent ial free out put for hoot er
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 User configurable High & Low alar ms set up
 Real t ime displa y t hrough so ft ware

8.3 APPENDIX

S.No. Title Checked By Sign/Date

1. Soft ware user manual

2.

3.

4.

9. FINAL REPORT

Accepted Not-Accepted
 DESIG N QUALIFICATION PRO TOCOL No.:
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Veri fied By: Dat e:

( )

Reviewed By: Dat e:

( )

10. DESIGN QUALIFICATION REPO RT APPROVAL :

Accepted Not-Accepted

Veri fied By: Dat e:

( )

Reviewed By: Dat e:

( )
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11. GLOSSARY & ABBREVIATION:

DP1 Diff er ent ia l Pr essur e

T EMP T emp er atur e
RH Relative Hu midit y
CC Change Contr ol
CGMP Cur r ent G ood Manu factur ing Pr actice
DQ D es ign Qualification
FAT Factor y Acceptance T ests
I/P I nput
IQ I nstallation Qua lif icat ion
MKT Mea n kinet ic T emp er atur e
N/A Not App licable
N/Av Not Ava ilable
National Accr editation Boar d f or T esting and Calibr ation
N ABL
Labor ator ies
NMT Not M or e T han
O/P Output
OQ Op er ational Qua lif ic at ion
P/N Part Numb er
PQ Per f or ma nce Qualif ication
Qty Quant it y
REV Revis ion

SAT Sit e Accepta nce T est

SOP Statement of Pur pos e
Spec. Specif icat ions
TS T echnical Sp ecif icat ions
URS Us er R equ ir ement Sp ecif icat ion
MOC Mater ia l of constr uct ion
PP Polypr op ylene
DP Diff er ent ia l Pr essur e s ens or
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TS T emp er atur e s ens or
SS Stainless St eel
VFD Var iable Fr equ ency Dr ive

UNITS OF MEASURE :

HP Hor sep ower

AT M At mosp her ic
o
C Degr ee C ent igr ade
L Liter
ppb Parts per billion
µ Micr on
µs/cm Micr o siemens p er centimet er
cfu / ml C olony For ming Units
KL Kilo L it er
NB Nominal Bor e
Kg/ cm 2 K ilogr a m p er Squar e cent imet er
M3/hr Cubic met er p er hour .
Mtr s Met er
kW Kilo watts