IOPQ MULTI-HS 15 Digital Multi-Position Hot Plate Stirrer - F20500531

DIGITAL MULTI-POSITION HOT PLATE Doc No: BQ-MP/HS15-
STIRRER
Date:
QUALIFICATION PROTOCOL
Digital Multi-Position Hot Plate Stirrer

MULTI-HS 15 (F20500531)
Make: Velp Scientifica

Model No: MULTI-HS 15 Digital - F20500531
Product: MULTI-HS 6/15 Digital Multi-position Hot Plate Stirrer.
Serial No.:
Instrument ID:
Supplied to (Client Details)

APL Research Center Injectables
Sy.No.313&314, Bachupally Village,
Quthubullapur(M), R R Dist. Hyderabad-500090
www.biomatiq.com
Page 1 of 16
STIRRER
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Table of Content:
S.No. Description Page No.

1. Document Approval 3
2. Objective 4
3. Purpose 4
4. Scope 4
5. Manufacturer and supplier 5
6. Purchase order Details 6
7. Inspection Report upon delivery 6
8. Safety Instructions 7
9. Installation Qualification (IQ) 8
10. Operational Qualification (OQ) 9 - 12
11. Performance Qualification (PQ) 13 – 14
12. Training Log 15
13. Warranty Certificate 16
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Page 2 of 16
STIRRER
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1. Document Approval:
M/s BiomatiQ:
The signature of the BiomatiQ Representative indicates that this qualification document's Design has been
prepared and approved for thorough testing of the Heating Block to ensure it has met all manufacturing and
performance requirements as specified by Velp Scientifica.
Authorized by: ________________________________
M/s APL Research Center Injectables:
The Owner/User signature indicates this document has been reviewed and approved to assure that it
effectively documents all customer requirements for qualification.
Client Scope Reviewed Approved
Name
Department
Signature
Date
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STIRRER
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2. Objective:
The objective of this qualification is to verify that the MULTI - HS 6/15 Digital Multi-position Hot Plate
Stirrer Make: ________________________, Serial No: _______________________ operates in accordance
with the specified URS Manufacturers recommended conditions and current Good Manufacturing Practices.
3. Purpose:
The MULTI - HS 6/15 Digital Multi-position Hot Plate Stirrer which is used to heat a sample at desired
temperature and maintain the same temperature throughout the experiment by stirring the sample with a
magnetic bead to maintain uniform temperature in the sample. For further detail refer our user manual.
4. Scope:
❖ The qualification protocol will consist of creating, reviewing & approval of an Installation
Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and user
Training of the equipment.
❖ The Installation Qualification verifies that the MULTI - HS 6/15 Digital Multi-position Hot Plate
Stirrer is appropriately identified, located and installed as per manufacturers recommended
conditions.
❖ The Operational Qualification will consist of validation of operational procedures as recommended
by the Manufacturer and within the scope of the URS. The system operation as mentioned in the
operation Manual including the various controls and user settings will be evaluated and confirmed.
❖ The Performance Qualification consists of verification of the system performance for the above-
mentioned purpose. The Heating Bath will be subjected to operation at different settings and the
performance evaluated to confirm with the URS and manufacturers recommendation.
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Page 4 of 16
STIRRER
Date:
5. Manufacturer & Supplier:
Manufacturer:
Company Name Velp Scientifica

Address Via Stazione, 16
20865 Usmate (MB) - Italy
Tel. + 39 039 628811
Contact www.velp.com/en-ww/contact-us
Supplier:
Company Name BiomatiQ Quality Solutions

Address 1386, Apuroopa Township, Opp More Super Market, Pragathi
Nagar, Quthubullapur, Hyderabad 500090 India.
Phone No. 9121010201

E-Mail contact@biomatiq.com
www.biomatiq.com
Page 5 of 16
STIRRER
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6. Purchase Order Details:

Purchase Reference Number: _____________________________
Copy Attached: Yes / No
Verified by (BiomatiQ): Reviewed by (Client):
7. Inspection Report Upon Delivery:

Unpacking Instructions:
❖ NOTE: Do not open any of the shipping containers unless a representative of BiomatiQ is present.
Warranty claims for missing items will not be honored unless an BiomatiQ representative is present
to verify the contents of each container as it is unpacked.
❖ These instructions provide information on how to unpack an instrument and place it on the
workbench, along with details of the equipment required to perform this task.
To unpack the Instrument:
❖ Carefully cut the plastic straps surrounding the packing box and remove the cardboard cover.
❖ Remove and set aside the inner boxes containing the instrument components.
❖ Inspect the instrument for any visible damage. If any damage is found, document the extent of the
damage in the General Preparation table of the product Checklist. You should also forward a copy of
the damage report to the BiomatiQ Office dealing with the supply of the equipment.
❖ Lift the instrument clear of the base and position it on the intended workbench.
❖ Once the instrument is located on the intended workbench, complete installation as detailed in the
Checklist.
❖ You may want to keep all of the packing materials in case it is necessary to move the instrument to
another location at a later stage.
Delivery Inspection signing off:
Verified by (BiomatiQ): Reviewed by (Client):
www.biomatiq.com
Page 6 of 16
STIRRER
Date:
8. Safety Instructions:
❖ Set up the appliance in a spacious area on an even, stable, clean, non-slip, dry and fireproof surface.
❖ It is an electrical instrument and must be placed away from wash basins/sinks, flammable
fumes and corrosive chemicals.
❖ Risk of burns! Exercise caution when touching the housing parts and ensure that the mains power
supply cable does not touch the heating base plate.
❖ Always check for proper earthing in the wall socket.
❖ Process and heat up any media that has a flash point higher than the adjusted safe temperature limit
that has been set to fixed safety circuit 120°C
❖ It is recommended that all such units should be connected to an electrical source, which is
protected by means of Miniature circuit breaker (MCB) and earth leakage circuit breaker (ELCB)
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Page 7 of 16
STIRRER
Date:
INSTALLATION QUALIFICATION(IQ)
9. Installation Qualification:
Verify the Instrument System components:

❖ Upon unboxing ensure that there is no transit damage and all the parts are intact.
❖ Check for the following items and pre-requisites, mark the availability in the table below.
Item Parameters Yes/No/NA

Digital Multi Position Hot Plate Stirrer. With 15 positions
Utilities:
Power Supply 230 V/AC, 50Hz.
Safety Provisions Earthing Should be <3V
Environmental Conditions 5-40°C
Foot Print/Table space 240x65x550 mm
User Manual Should be available
Temperature control Knob 01No.
Speed Control Knob 01No.
Timer/menu Button 01No.
Warranty Card 03 years
Installation Qualification Signing Off:
Comments:
Name Designation Signature & Date
Performed by
(BiomatiQ):
Reviewed by
(Client):
Approved by
(Client):
www.biomatiq.com
Page 8 of 16
STIRRER
Date:
OPERATIONAL QUALIFICATION(OQ)
10. Operational Qualification:
The Aluminum alloy heating plate with ceramic coating (1) ensures:
❖ Optimum heat distribution and a high specific power thanks to the circular configuration
❖ Temperature homogeneity
❖ High resistance to thermal stress and thermal shock
❖ High resistance to chemical agents and surface abrasion.
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Page 9 of 16
STIRRER
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❖ Magnetic stirring is generated by neodymium magnets, driven by brushless motors which offer a virtually
unlimited duration. Size and shape of the magnetic stir bar determines the stirring efficiency at any given
speed. The stirring bar code which satisfies most applications for MULTI-HS 15 is the A00001057 (6x20
mm)
NOTE: The vessel must be made of a suitable material to withstand the foreseen temperature.
NOTE: Using the heating plate at high temperatures may cause discoloring. This does not alter the thermal,
mechanical and chemical resistance of the plate in any way.
10.1 Operating Modes:
Critical variables Acceptance criteria Observation

➢ Switch on the instrument through the main switch (2)
Commissioning ➢ Display shows software version, the last set point values and
OFF on both displays (if “Start mode” is set on Stop.
➢ Adjust motors speed set point by turning the speed control
knob (3)
➢ Click the knob to start stirring
Stirring ➢ The speed increases until set point achievement
➢ A microprocessor ensures constant speed even when the
viscosity changes (counter-reaction)
➢ Switch off the stirring by clicking the knob
➢ Adjust heating plate temperature set point by turning the
temperature control knob (4)
➢ During all the time of set point adjusting, the temperature set
point led (B) is switched on
➢ Click the knob to start heating
➢ Display shows real plate temperature for 3 seconds and
temperature set point for 1 second alternatively
➢ When temperature set point is visualized, the relative led (B)
turns on
➢ While the instrument is heating, the Heating ON led (A)
Heating
turns on
➢ Switch off the heating by clicking the knob
➢ When heating function is off and the heating plate
temperature exceeds 50 °C, the message “Hot” is shown on
the temperature display until temperature falls below 50 °C
NOTE: This warning is not active if the instrument is not powered.
NOTE: In case of black-out, once the power is back the device restarts in the set
restarting mode (“Strt mode”)
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Page 10 of 16
STIRRER
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➢ To access the timer function, click the Timer/auto

reverse/lock button (E)
➢ On the displays tInE h h: n n are visualized.
➢ Set the timer turning the speed control knob until the desired
nE E nE
value and click to confirm
➢ Timer led (C) turns on
➢ Timer countdown starts when one of the main functions is
on or when temperature reaches set point value (see chapter
Timer
5, “Time Strt”)
➢ When countdown is active, timer led flashes.
➢ Esc timer menu: a) click twice timer/auto reverse button
b) wait 5 seconds without touching any
knob
➢ When timer countdown ends End tIne are
shown until operator action. It’s possible stirring continues if
nE
the parameter “time Sped” is ON.
➢ To access autoreverse function click twice the
Timer/autoreverse/lock button (D)
➢ On the displays A.r Eu n n. s are visualized
Autoreverse ➢ Set the autoreverse turning the speed control knob until the
desired value and click to confirm
➢ The autoreverse led (D) turns on
➢ Autoreverse starts when stirring is on
➢ Holding the Timer/autoreverse/lock button (E) for 3
seconds, the instrument will lock its settings during
operations.
Lock ➢ Unlock the control panel by holding the
Timer/autoreverse/lock button (E) for 3 seconds.
➢ If other buttons are clicked while the instrument is locked,
the LEDs around the lock button will blink for few seconds.
10.2 Settings
❖ Press both knobs for 3 seconds to enter into the setting mode when heating and stirring are off.
❖ Clicking the Timer/autoreverse button (F) it is possible to pass from one of the following parameters
to the next ones.
➢ The speed can be set on scale value from 100-1000 RPM

10.2.1 Speed control
step 100rpm.
10.2.2 Temperature ➢ The temp set values display from Room temperature from
Control 50 to 120oC step 10oC.
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Page 11 of 16
STIRRER
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➢ Stop: when the instrument is switched on through the

main switch, OFF is visualized on both displays.
10.2.4 Starting Mode
➢ Run: when the instrument is switched on, it restarts to
work with the last set points set.
➢ Snap: timer countdown starts as soon as one main
10.2.3 Timer/ function (Temperature/Speed) is on.
Autoreverse /lock ➢ Set P: timer countdown starts when temperature set point
button is reached. The Timer can be set from 1min to
99h:59min.
10.2.4 Continue
stirring after timer ➢ If “on”, stirring continues after timer end
end
10.2.5 Reset ➢ It allows to restore default setting parameters
Note: Click the stirring control knob to visualize the set value. Turn the knob to set the new value and
click to confirm.
To esc setting mode wait 10 seconds without touching any knob or push both knobs at the same time.
Operation Qualification Signing Off:
Comments:
Name Signature & Date
Performed by
(BiomatiQ):
Reviewed by
(Client):
Approved by
(Client):
www.biomatiq.com
Page 12 of 16
STIRRER
Date:
PERFORMANCE QUALIFICATION(PQ)
11. Performance Qualification:

❖ The purpose of performance Qualification is to establish that the equipment and its components are
as per the specifications and are installed as per the approved design.
11.1 Critical parameters to be met:
Critical Variables Acceptance Criteria Observation
Operate the Digital Multi Hotplate

The Instrument should be operational.
Stirrer as per manual
11.2 Temperature Performance Details:
Sl. No. Set temp. Observed temp. Deviation in temp. Remarks
1.
2.
3.
11.3 RPM Performance Details:
Sl. No. Set RPM Observed RPM Deviation in RPM Remarks
1.
2.
3.
11.4. Result:
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Page 13 of 16
STIRRER
Date:
11.5 Attachments:
Sl. No Title Document. No
Performance Qualification Signing Off:
Comments:
Name Signature & Date
Performed by
(BiomatiQ):
Reviewed by
(Client):
Approved by
(Client):
www.biomatiq.com
Page 14 of 16
STIRRER
Date:
12. Training Log:

Below trainees are authorized to Operate and maintain this instrument in daily routine.
S.No Trainee Name Department Designation Signature
Trainer Signature & Date (BiomatiQ):
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Page 15 of 16
STIRRER
Date:
13. Warranty Certificate:
We confirm that the products supplied by us under the below details are under warranty and BiomatiQ
Quality Solutions, Instrument, shall, as and when called for during the period of warranty, provide Service,
Repair and ensure normal running of the equipment within the shortest possible time.
Product Description
Product Name
Product No
Serial No
Make
Warranty Period
Date of Installation
Client Name & Address:
Authorized Signatory (BiomatiQ):
www.biomatiq.com
Page 16 of 16

IOPQ MULTI-HS 15 Digital Multi-Position Hot Plate Stirrer - F20500531

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DIGITAL MULTI-POSITION HOT PLATE Doc No: BQ-MP/HS15-

Digital Multi-Position Hot Plate Stirrer

Make: Velp Scientifica

Supplied to (Client Details)

S.No. Description Page No.

Authorized by: ________________________________

M/s APL Research Center Injectables:

Client Scope Reviewed Approved

5. Manufacturer & Supplier:

Company Name Velp Scientifica

Company Name BiomatiQ Quality Solutions

Phone No. 9121010201

6. Purchase Order Details:

Verified by (BiomatiQ): Reviewed by (Client):

7. Inspection Report Upon Delivery:

Verified by (BiomatiQ): Reviewed by (Client):

Verify the Instrument System components:

Item Parameters Yes/No/NA

Installation Qualification Signing Off:

Name Designation Signature & Date

10. Operational Qualification:

Critical variables Acceptance criteria Observation

➢ To access the timer function, click the Timer/auto

➢ The speed can be set on scale value from 100-1000 RPM

➢ Stop: when the instrument is switched on through the

10.2.5 Reset ➢ It allows to restore default setting parameters

Operation Qualification Signing Off:

Name Signature & Date

11. Performance Qualification:

11.1 Critical parameters to be met:

Critical Variables Acceptance Criteria Observation

Operate the Digital Multi Hotplate

11.2 Temperature Performance Details:

Sl. No. Set temp. Observed temp. Deviation in temp. Remarks

11.3 RPM Performance Details:

Sl. No. Set RPM Observed RPM Deviation in RPM Remarks

Sl. No Title Document. No

Performance Qualification Signing Off:

Name Signature & Date

12. Training Log:

S.No Trainee Name Department Designation Signature

Trainer Signature & Date (BiomatiQ):

13. Warranty Certificate:

Client Name & Address:

Authorized Signatory (BiomatiQ):

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