Technical Comparison & Advantages of NEWTRONIC Products Over Other Manufacturers

Sr. Item System Provided by NEWTRONIC Other Manufacturers Remarks

No.
1. Chamber Operations  Chamber Operations based on  Relying on traditional  ECOtronic System has led to significant gains in
ECOtronic system incorporating methods of controlling Power & Water Consumption compared to
the principles of Dew Point Temperature & Rh traditional methods
Control as per the
Psychrometric Chart leading to
90% saving in water & 70%
saving in Power Supply

 A Dew Point is the temperature

to which air must be cooled in
order to be saturated with the
water vapour already in the air
ie. temperature at which dew
will form

 Operations fine-tuned to work

perfectly well for Indian
conditions
2. Humidity System  Humidity is primarily
controlled through the
principles of Dew Point as per
the Psychrometric Chart.
 In other-makes, Humidity is
generated through steam-
based humidifiers through
boiler tank. As a result hot
Rh is generated in the
Walk-In leading to rise in
Temperature
 Humidity generation through steam-based
humidifiers leads to an endless cycle wherein
Cooling System & Humidity System have to work
continuously in tandem. As a result, there is
significant Water & Power consumption

 This rise in Temperature

leads to the requirement of
additional cooling

 Additional cooling leads to

condensation on the cooling
coil thereby requiring
additional humidity
Page 1 of 9
Last Modified Date: 1-Jul-2019
 Sr. Item System Provided by NEWTRONIC
No.
3. Refrigeration  As per the new ECOtronic
System system, the cooling coil
temperature is controlled as
per the Dew Point
 Rh Conditions are therefore
achieved from ambient
humidity itself since moisture
absorption is minimal.
 It has also ensured the cooling
system is not ON continuously
but rather switches ON only on
a need-basis
 The ON time of the cooling
system is required for only
approx. 8 hours in a time
period of 24 hours
4. Further Advantages  No Utility area (of 800-
of ECOtronic System 1000mm) on the back-side
 No deviations during short term
events of door opening &
power failure
 Components operate only on a
need-basis
5. PLC-based Control  Complete Chamber Operations
System (for all Walk-Ins & Stand-alone
Humidity Chambers) are
controlled via a PLC of very
high-quality & reputed make
 There is a strong program logic
Last Modified Date: 1-Jul-2019
Other Manufacturers
requirement
 Cooling System continues to
remain ON throughout the
Chamber operations
 The claimed Chilling System
is more of a water-bath
with no definitive numbers
on power & water
reduction
 It also leads to higher AHU
requirements due to heat
dissipation inside the room
 No safety feature in the
event of water-freezing or
overflow of makeup tank
 No such advantages
 The PLC is not of an
established brand &
program logic is not very
robust
 Also, there is no facility to
send an email directly in
Page 2 of 9
Remarks
 Technical details such as flow rate, Δt of cooling
coils, auto-changeover upon failure of pump, etc
are not clear
 Chances of breakdown thereby increase
 Additionally, breakdowns cannot be anticipated
well-in-advance & their preliminary diagnosis also
pose a challenge
 Absence of utility area has led to greater storage
area within the Walk-In
 Less excursions has led to lesser filing of deviations
 Lesser failure of components & lesser breakdown of
Chamber
 PLC is an advanced, reliable & real-time way of
executing the chamber operations
 It acts quickly to achieve & maintain the set
conditions
 It has immunity to electrical noise, resistance to
vibrations and impact & facility for extensive
input/output (I/O) arrangements
 Sr. Item System Provided by NEWTRONIC
No.
to ensure high performance
standards
 An email alert directly from
the PLC in case of deviations
 To ensure Data Integrity, there
is tamper-proof flow of data
from PLC to Software.
6. Accurate  Temp Uniformity: ±1ºC
determination of
T/RH Uniformity  T/RH uniformity in Walk-Ins is
ensured through establishing
an accurate air-pattern. This,
in turn, is established
scientifically from an air-flow
stimulation software
 Not only uniformity of
conditions are established but
also, Hot & Cold Zones, Dry &
Humid Zones are identified in
the Walk-Ins
7. Software  A server-based, web browser-
based Software that ensures
ease-of-access
Last Modified Date: 1-Jul-2019
Other Manufacturers Remarks
case of deviations  An in-built memory within the PLC avoids additional
hardware & better data reliability
 In other-makes, the HMI
Display has an external
storage device port (such as
USB Port for Pen Drive)
thereby making the data
vulnerable to theft and
manual intervention. This is
a potential violation to
Data Integrity principles
 Temp Uniformity: ±2ºC  Very important documentary evidence for
justification of sensor positioning in Walk-Ins. The
 No such corresponding same is provided as part of PQ documents.
features
 Auditors are increasingly asking for sensor
placement justification
 Currently no other software  Software ensures user team is real-time updated
in the area of Stability with all events in your Stability & Micro
Chamber Management departments
offers so many features
Page 3 of 9
 Sr. Item System Provided by NEWTRONIC Other Manufacturers Remarks
No.
 Robust design incorporating all  Operations ensure user team is ready for any
the requirements of 21 CFR surprise audits
Part 11
 Eliminate need of daily print outs & reduce
 Bouquet of additional features Operational Costs
for ease of operations. Refer
table below for complete
feature list

 Significant emphasis on Data

Integrity
8. Safety Measure  If there is a Temperature  The entire Walk-In or  When the entire chamber shuts down, the excursion
during Temp. Overshoot or Undershoot then Standalone chamber shuts period is significantly high leading to filing of
Overshoot / it will lead to the supply cut- down greater number of deviation reports & justification
Undershoot off of only that specific of the downtime
component which is faulty
9. Humidity Overshoot  A Hygrostat is provided to cut-  Not provided  If sample safety for high humidity is not available
safety off the humidifier at a value then it becomes difficult to comply with GMP safety
greater than 5%RH of set value. requirements.
10. Alarms  Separate recordings for alarms  No separate recording of  Full traceability not available
and events as and when they alarms & events. Also, user  Partial compliance with 21 CFR part 11
occur, with user comments. cannot enter any comments
Same is tracked in audit trails  No feature of additional  Additional alarms quickly provide the exact reason
 Additional alarms on circuit alarms of breakdown
failure & thermostat trips
11. Mobile Alert System  Only one modem and SIM card  Individual modem and SIM  An effective Mobile Alert System provides accurate
between all connected card for each chamber information, minimizes the need of user
chambers.  Message showing only intervention as well as additional hardware.
 Alert message with full prefixed message as
information having “Scanner alert”
 Name of chamber
 Alarm detail
 Sensor id &
 Present Value
12. Booster Cooling  If the chamber temperature  No such system provided  Efficient control of temperature leads to minimal
deviation is at least 2°C more excursion periods, effective stability tests &

Page 4 of 9
Last Modified Date: 1-Jul-2019
 Sr. Item System Provided by NEWTRONIC
No.
than the set value then both
the primary Cooling system &
standby cooling system switch
on together to bring the
temperature within range
11. Surge Arrester  Surge Arrester is provided to
filter electrical noise in-line
and noise generated by
chambers.
12. Component Working  Calculation of Working Hours
Hours for all major components
13. Standby Cooling Switchover to Standby systems is
System  Automatic upon detection of
fault
 Scheduled (via Touchscreen)
 Manual (via Touchscreen)
14. Standby Humidity Switchover to Standby systems is
System a. Automatic upon detection of
fault
b. Scheduled (via Touchscreen)
c. Manual (via Touchscreen)
15. Power Supply  Single phase for up to 30,000
Litre capacity (& up to 70,000
Litres in case of Walk-In
Humidity (Stability) Chambers
16. Service Engineers  NEWTRONIC also ensures
engineers are well-trained with
all-round knowledge on
important aspects of
refrigeration, humidity,
Last Modified Date: 1-Jul-2019
Other Manufacturers
 No such system provided
 No such feature
 Manual switchover requires
change in the control
system wiring
The switchover is only
automatic
 3 phase even for Walk-Ins
as small as 4,000 Litres
 Knowledge of engineers are
silo-based
Page 5 of 9
Remarks
reduced consumption of power
 Electrical noise can interfere with the function of
other instruments in the lab. They go through
disturbance and may get damaged on long term
basis.
 Facilitates prompt Preventive Maintenance for
better life
 Avoids maintenance related NCs
 Requires additional documentation in SOPs & may
void the validation
 Not an efficient way to execute manual switchover
 Increases dependency on service team &
engineering department
 Not providing scheduled or manual switchover will
lead to unnecessary burden on the primary system
 Auditor can raise NCs on the operations of the
standby system and its usefulness
 Electrical load will be higher & it leads to higher
consumption of power
 In the event of a breakdown, the preliminary
diagnosis & subsequent resolution are generally
handled by a single contact point. This decreases
the breakdown time leading to lower excursion
period
 Sr. Item System Provided by NEWTRONIC Other Manufacturers Remarks
No.
electrical & software

Page 6 of 9
Last Modified Date: 1-Jul-2019
Introducing NEWTRONIC ICDAS v2.1 - A state-of-the-art Chamber Management Software

Page 7 of 9
Last Modified Date: 1-Jul-2019
 S No Major Features Benefits
1 Server-based Installation, web browser-based 21 CFR Part 11 Requires no installation at Client-side
Ready Software Eliminates multiple software installations & qualifications
Ease-of-access: Accessible for any desktop/laptop

2 Perpetual License with unlimited no. of users Cost-effective requiring only one-time CAPEX expenditure

3 Restricted rights & privileges to access the system at user- Very Important from Data Integrity point of view
level

Flexibility of defining multiple user-groups such as Operator

Supervisor, Authorization, Admin, Super-Admin (at Plant-
level)

There is also Departmental segregation of chambers, data

and users

4 e-Review, e-Approval, e-Signature, e-Comments of: Make your plant paperless & eliminate the task of daily print-
 Data Logs outs
 Alarms
 Audit Trails
 Equipment Parameter Modifications
5 Comprehensive Audit Trails: Audit Trails are becomingincreasingly important from Auditor
 Alarms point of view
 Alarm Acknowledgement
 User Activity
 Equipment Activity
 email Audit Trail
 SMS Audit Trail

6 Customized SMS & Email Alarms to Engineering & Lab users Ensures the involvement of the correct team to attend to an
activity

Page 8 of 9
Last Modified Date: 1-Jul-2019
 7 System generated proactive emails on pending activities: Staying audit-ready on a daily basis
 Data Pending for Review
 Data Pending for Approval
 Alarms Pending for acknowledgement
 Pending database archival

8 A real time window user can see status of all connected Very Important screen for ease-of-operations. User can
chambers in one window at same time attend to only those items that flash in RED, if any
9 Viewing I/O Status & Running Hours of all major components Leads to effective Preventive Maintenance activities
10 Automatic & Manual daily data backup facility. Automatic
data backup can be done both, remotely & locally
11 Online Diagnosis For faster resolution to any software/PLC matters
12 Harmonization of reporting format (header, footer, etc) &
other such operations throughout the plant
13 Various inbuilt security features such as 2-level
authentication, password aging, auto-logout, security
lockout, password re-confirmation, etc
14 Ability to calculate MKT (Mean Kinetic Temperature)
15 Possible to connect to all leading LIMS packages

Page 9 of 9
Last Modified Date: 1-Jul-2019