Validation Protocol

For Climate Incubator

Document No.:

BIOBASE BIODUSTRY(SHANDONG)CO., LTD

 Table of Contents

Validation Team Protocol Approval

Chapter 1 Introduction 4

Chapter 2 Installation Qualification 8

Chapter 3 Operation Qualification 19

Chapter 4 Final Report and Approval 29

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VALIDATION PROTOCOL APPROVAL:

Prepared By/Title/Date: ______________________________________________

Verified By/Title/Date*: ______________________________________________

Approved By//Title/Date: ______________________________________________

Approved By//Title/Date: ______________________________________________

Approved By//Title/Date: ______________________________________________

*Note: If the validation is executed by a service provider, then the engineer who does the
validation is the performer, and customer is the first verifier, reviewer and approver.

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 Chapter 1 Introduction

The purpose of this installation, operation, and performance qualification is to provide

documented evidence that the equipment is installed properly and its performance meets
specifications set forth by the manufacturer.

Scope
This protocol is to validate theBIOBASE BIODUSTRY (SHANDONG)Co., LTd Climate
Incubator at initial installation, modification and relocation.

Model _________________________________

Serial No. _________________________________

Located _________________________________

Used to _________________________________

Revalidation

Frequency of revalidation depends on the usage of the system. It is recommended that

the system needs a revalidation when any of the following happens:

 Change control board

 Change temperature sensor

 Annual maintenance (OQ only)

 System relocation

Responsibilities

Person overseeing the design will perform the qualification and record the information.
The responsible engineer will verify the records and write the report.
Quality Assurance will review and approve the Protocol and Report.

Procedure

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The installation and operational qualifications (IQ & OQ) will be conducted by physically
installing and operating the system, comparing it to relevant documentation for
appropriate functioning and documenting results on the attached data sheets for future
change control. Performance qualification (PQ) will be performed by validating resistivity
of the product water from the system. TOC and microbial burden tests are optional.

1.Scope of application
Widely used in microbial cell culture, seed germination, seedling test, plant cultivation, and
insects, small animal husbandry etc.. Accurately simulate different environmental and climatic
conditions.

Test Equipment

To insure test equipment is documented and copies of calibration certificates are present.

Ensure all test equipment is documented in the table below and copies of calibration
certificates are appended to this action.

Calibration Date of Next

Instrument (Model) Series No.
Certificate No. Calibration
Thermometer
hygrometer

illuminance meter

Watch

The calibration of all test equipment used shall be traceable to national standards (or an
international equivalent).

The instruments shall be in known working order.

The calibration status of the equipment shall be valid (within calibration period, prior to
next calibration).

Acceptance criteria:
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All of the above are properly calibrated and accepted.

Accepted:

Signed: __________________________________ Date:________________

Comments & corrective actions required: (detail section and test number)

Reviewed:

Signed: __________________________________ Date:________________

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 Chapter 2 Installation Qualification
OBJECTIVE
To ensure that the system installed conforms to the purchase specifications and the
manufacturer’s User Guide, and to document the information that the equipment meets
specifications.

SCOPE
To be performed at time of installation, modification, and relocation.

RESPONSIBILITY
 Person overseeing the installation will perform the qualification and record the
information.
 The responsible engineer will verify the records and write the report.
 Quality Assurance will review and approve the IQ Protocol and Report.

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DESCRIPTION OF THE SYSTEM BEING INSTALLED:

ITEM CONTENT

Name of the product Climate Incubator

Manufacturer and Address Biobase Biodustry(Shandong) Co., Ltd
Contract/Order Number
Model
Serial Number
Manufacturing Date
Asset Number
Location

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SYSTEM SPECIFICATIONS
Model
BJPX-A250
Parameter

Humidity Range 50-90%RH

Humidity
±5%-7%RH
stability
Temperature Without Lighting: 4~50℃
range With Lighting:10~50℃
Temperature
±1℃(Balanced work)
fluctuations
Cycle range of 0 to 100, of 30 segments, each time setting range: 0
Working Hours to 99 hours
0 to 59 minutes, if the period is set to 0, for the continuous work
Supply voltage 220V、50Hz
Input power 860W
Shelf number 3Block

REQUIREMENTS OF SUPPORTING UTILITIES

1. Ambient temperature：±5~35℃

2. Relative humidity：≤80%RH

3. The surrounding without strong vibration and corrosive gases

4. Should avoid direct sunlight or other hot and cold sources

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IQ CHECKLIST

 Packaging
 System and Accessories
 Documentation
 Installation Environment
 System Installation

CONFIRMATION OF PERSONNEL INVOLVED IN INSTALLATION QUALIFICATION

Name (Print) Signature Date Position Department

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INSTALLATION QUALIFICATION

A. Packaging

Description Acceptance Criteria Result

(Pass/Fail/Deviation)

External Packing Intact

External
Packaging No Water Marks

No Forced Entry/Damage

Body incubator External intact, no damage

Inspection
All external connectors are intact
Conclusion:

Inspected by: Date:

Confirmed by: Date:

B. Main body and Accessories

Description Acceptance Criteria Result

(Pass/Fail/Deviation)

incubator Name Climate Incubator

Model
Biobase
Manufacturer Biodustry(Shandong) Co.,
Ltd.

products Serial No.

Conclusion:

Inspected by： Date：

Confirmed by: Date:

C. Documents
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 Description Acceptance Criteria Result Located
(Conform/Deviation) in
User Manual One Set

Validation One Set

Protocol
Certificate of One
Quality
Purchase Contract No:
Contract
Conclusion:

Inspected by： Date：

Confirmed by: Date:

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 D. Installation Environment

Result
Description Acceptance Criteria
(Pass/Fail/Deviation)
Power 220VAC 10％，50Hz or 110
VAC, 60 HZ
Ambient temp. ±5~35℃
Relative Humidity ≤80%RH
Conclusion:

Inspected by: Date:

Confirmed by: Date:

E． System Installation
Description Acceptance Criteria Result
(Pass/Fail/Deviation)
The surrounding without strong
1 vibration and corrosive gases

Should avoid direct sunlight or other

2 hot and cold sources

High concentrations of dust around,

3 in addition to maintain the level of
installation, should reserve some
space between the device and the
wall

Should be installed in a
4 well-ventilated place

Power supply Power supply is properly

grounded

Power cord is connected

Conclusion:

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Inspected by： Date：

Confirmed by: Date:

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DEVIATION REPORT

Deviation:

Impact on Installation and Outcome:

Name and Signature: Date:

Suggested Remedy:

Justification on Acceptance:

Name and Signature： Date:

Verification After Correction

□ Accepted □ Rejected

Name and Signature： Date:

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ISSUES/COMMTS

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IQ CONCLUSIONS:

The Climate Incubator (Serial number ) is properly installed

per the Installation Qualification protocol. All related items are inspected and meet
user’s and manufacturer’s criteria.

System Installation Qualification is completed and ready for the Operation Qualification.

VALIDATION IQ RESULTS APPROVAL

Report Written By_______________________ Title__________________________

Signature_____________________________ Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________ Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________Date__________________________

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 Chapter 3 Operation Qualification

OBJECTIVE
To determine that the system/equipment operates according to specifications, and to
record all relevant information and data to demonstrate it functions as expected.

SCOPE
To be performed after installation, modification or relocation, after the Installation
Qualification has been completed.

RESPONSIBILITY
 Person responsible for operating the system/equipment will perform the qualification
and record the information.
 The supervisor will supervise the study, verify the completion of the records, write the
deviation report and the Operational Qualification Report.
 Quality Assurance will review and approve the OQ Protocol and Report.

CONFIRMATION OF PERSONNEL INVOLVED IN INSTALLATION QUALIFICATION

Name (Print) Signature Date Position Department

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APPROVAL FOR OPERATION QUALIFICATION (OQ)

Check item Yes No

IQ Completed and Approved

OQ Protocol is Completed
Signature Date:

DOCUMENT CHECK

SOP Title Document Location QA Approval Date

Number

Name and Signature： Date：

TRAINING RECORDS
Course on SOP# Staff Name Date

Name and Signature： Date：

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OQ Checklist
 System Operations
 Temperature setting
 Lighting & humidity
 Defrost

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  OPERATION QUALIFICATION

A. Handing Precautions

Item Confirmation Process

1. The equipment first start, the controller internal parameter (in
addition to the set temperature, time) Do not modify.
2. Lighting Do not open unless necessary.
3. Work indoor vertical wind circulation and each bracket items
Handing precautions should not be placed too full.
4. Ambient temperature is above 35 °C or box temperature
higher than 50 °C, non-running compressor.
5. Should cut off the power supply when the device is not in
use, keep dry, clean inside and outside.

Results
Conclusion

Recorded by： Date：

Confirmed by: Date:

B. Temperature Controller Description

Panel：

Button, the indicator description:

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 Item Confirmation Process
1. ：Main interface and query interface, click to switch
query interface and the main interface; setting
interface long press to enter the program;
Setting interface, click the down switch value,
long press to exit the setting interface;

2. ：Main interface and query interface, click to turn on

or turn off the backlight;
Set interface, an increase in the value or switch up
parameters;

3. ：Main interface and query interface, long press to

Temperature control turn on or turn off the defroster (see defrost
parameters -> manual defrost);
Decrease the value or down to switch the
parameter setting interface;

4. ：Main interface and query interface, long press to

enter the parameter menu;
Set interface, switching the position of the
cursor;

5. ：Click to turn on or off lighting;

6. ：Press 2 seconds to run or stop the program.

Conclusion

Recorded by： Date：

Confirmed by: Date:

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C. Introduction to use
Example:
equipment needed to start work after 120 minutes, for 10 cycles, each cycle set in
paragraph 2, first paragraph of the need to work for 720 minutes, the temperature control at
30 °C, the illumination of 6, and humidity control at 60% RH; firstSec 1200 minutes, the
temperature is controlled at 10 °C, light intensity for four, humidity control at 50% RH.

Operation process Results

a) Long press the "SET" button for 4 seconds, enter the total set
interface;

b) Click on the ">" key to move the cursor to switch to the value of
the total cycle, using the "∧" and "∨" key to modify the set
value of the total cycle of 10; then click on the "SET" button, the
cursor is in the total number of segments the value, modify the
settings of the total number of segments 2; then click on the
"SET" button, the cursor on the value of the appointment, to
modify the appointment time is 120 minutes;

c) then click on the "SET" button, enter the first paragraph set
interface, the cursor on the value of the temperature, the
temperature setting is modified to 30 °C; click on the "SET"
key, the cursor on the value of the humidity, themodify the
humidity setting to 60% RH, and then click on the "SET" button,
the cursor is in the value of the illumination to modify
illumination setting is 6; then click on the "SET" button, the
cursor on the value of the time, to modifyThe time setting is 720
minutes;

d) and then click on the "SET" button to enter the set state in
paragraph 2, as described above, followed by the setting of
temperature, humidity, light intensity, and time was revised to
10 °C, 50% RH, 4; last long press the” SET"button for 4
seconds to exit the setting interface, return to the main interface,
set;

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 e) long press "R / S" button for 2 seconds, the controller starts
timing of the appointment time running status display:
Appointment timing ... 120 minutes, the program began to run
after the first paragraph;

f) program into the first paragraph, if the internal parameters of

timing, then the timer starts running status display: timing ...;
timing way, this time running status display: running ...when the
temperature reaches the set value, the time to start; timing way,
when the temperature and humidity reaches the set value, the time
to start;

g) after the end of the first paragraph of the timing to the second
stage, after the end of the second paragraph of the timing, enter
the first paragraph of the second cycle, and so on; after the end of
the second paragraph of the timing of when the 10th cycle, the
end of the program is running, close all out put, buzzer (press any
key to mute).

h) Note: When the humidity is set to 0, humidification and

dehumidification are not turned on, can be used as a biochemical
containers used.

Conclusion

Recorded by： Date：

Confirmed by: Date:

D. Parameter description:

Temperature parameters: password (the main interface, long press”>” 3 seconds to enter the
password interface)

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Parameter Parameter Function Range (factory
name parameters)
When measuring temperature> set
Over-temperature temperature + over-temperature alarm,
alarm instrument warning lights are bright, cut 0.0～50.0 (5.0) ℃
heating protection relay, open refrigeration
buzzer sounds;
Zero adjustment Zero adjustment = mercury thermometer -99.～99.9(0) ℃
readings - Display temperature;
When the deviation of the actual
temperature, adjust the parameter values to
Full-scale tune correct;
Whole -999～999（0）
Full-scale adjustment = 1000 * (mercury
thermometer readings - Displays
temperature) / temperature display
When measuring temperature> = set
Off heating
temperature + off heat, turn off the heating -50.0～50.0(2.0) ℃
output
When the control mode is 0, if the set
temperature <environmental temperature
normally open temperature, the compressor
Normally open
is automatically switched to the normally -50.0～50.0
temperature
open type; when the control mode 1, if the (10.0) ℃
set temperature <normally open
temperature, the compressor is
automatically switchedis often open.
When the control mode is 2, the opening
Open point of the refrigerant for: measuring
refrigeration temperature> = the set temperature + open -20.0～20.0(0.0) ℃
refrigeration.

Control mode 2, the cooling off point: the

measurement temperature <= set
Close
temperature + Close refrigeration; (Close
refrigeration -20.0～20.0(-0.2) ℃
refrigeration should be less than open
refrigeration points)

Refrigeration Compressor delay protection time, the 0 to 3600 (180)

delay compressor is stopped and re-open time seconds
interval> = delay time;

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Conclusion:

Recorded by： Date：

Confirmed by: Date:

E Defrost parameters: password (the main interface at the same time long press
"SET" and "∨” 3 seconds to enter the password interface)

Range
Parameter Parameter Function
(factory
name
parameters)
Interval of 0.0 ~ 9.0 ℃ defrost interval time in hours 0～200（12）
one h
Interval of 9.1 ~ 15.0 ℃ defrost interval time in hours 0～200（24）
two h
Interval of Greater than 15. 0 ℃ when the defrost interval 0～200（72）
three time in hours h
Defrost a Output of 0.0 ~ 9.0 ℃ defrost time, in seconds 0～300（60）
S
Defrost 9.1 ~ 15.0 ℃ defrost output time in seconds 0～300（60）
two S
Defrost Output of greater than 15.0 ℃ defrost time, in 0～300（60）
three seconds S
0： No manual defrost function;
Manual
defrost 1：Main interface, long press "∨" to 8 0～1（0）
seconds, start defrosting, defrost time based on
the parameter: defrost, defrost, defrost three;

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DEVIATION REPORT

Deviation:

Impact on Operation and Outcome:

Name and Signature： Date：

Suggested Remedy:

Justification on Acceptance:

Name and Signature： Date：

Verification After Correction

□ Accepted □ Rejected

Name and Signature： Date：

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ISSUES/COMMENTS

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OQ CONCLUSIONS
The Climate Incubator (serial number: ) has passed
Operation Qualification per approved OQ protocol. All items inspected meet user’s and
manufacturer‘s specifications.

VALIDATION TEAM OQ RESULTS APPROVAL

Report Written By_______________________ Title__________________________

Signature_____________________________ Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________ Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________Date__________________________

Approved by Title__________________________
(Print name)

Signature ______________________________Date__________________________

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