Doc No.

PVR-019-001
Validation Report Issued date 2020.04.23

Process Name: Packaging validation Page 1 / 14

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□ Non-managed document

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Production Production
Dept./Team QMR
management management
Name Lee, Song-Ha Hyun, Ji-Hye Yoon, Ju-O

Date 2020/ 04/ 23 2020/ 04/ 23 2020/ 04/ 23

※ This document is effective from the approval date by the approver.

Revision history
No. Issued date Contents Dept.
Production
0 2020.04.23 Initial Validation
management

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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Process Name: Packaging validation Page 2 / 14

Contents

1 Overview .................................................................................................................................................... 3
1.1 Purpose .............................................................................................................................................. 3
1.2 Scope ................................................................................................................................................. 3
2 Reference ................................................................................................................................................... 3
3 Product ....................................................................................................................................................... 3
4 Test Process ................................................................................................................................................ 4
5 Test Condition & Test Result ................................................................................................................... 5
Annex 1. Performance check (Sterilization) ................................................................................................ 13

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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1 Overview
1.1 Purpose
The purpose of this report is to confirm the effectiveness of packaging and sterilization after the production of UTM is completed.

1.2 Scope
Model name Gmate® UTM
Process name Packaging process
List Component Quantity
Packaging Contents Universal Tranport Medium Medium (2ml) 1 ea
Gmate® Swab Sterile swabs (2.1g) 2 ea
Date of Test April 06, 2020 ~ April 22, 2020
Validation Type ■ Initial □ Revalidation □ Other ( )

2 Reference
2.1 Applicable standard
2.1.1 ISTA Procedure 2A:2011

2.2 Related document

2.2.1 [PSQP-705] Procedure of validation

3 Product
3.1 Description
3.1.1 Manufacturer: PHILOSYS Co., Ltd.
3.1.2 Product: Universal Transport Medium
3.1.3 Model: Gmate® UTM
3.1.4 Serial No.: -
3.1.5 Sample Quantity: 1 Box (50 Set)

3.2 Photograph

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4 Test Process
Using one process among next two kinds of process

4.1 Operating test

PERFORMANCE CHECK

PRODUCT

OPERATING TEST

END

4.2 Non-Operating Test

PERFORMANCE CHECK

PRODUCT

NON-OPERATING TEST

PERFORMANCE CHECK

END

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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Validation Report Issued date 2020.04.23

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5 Test Condition & Test Result

5.1 Atmospheric Conditioning (1 of 5)
Manufacturer PHILOSYS Co., Ltd. Dept. in charge Production management team
Product Universal Transfer Medium Tester Lee, Song-Ha
Model Gmate® UTM
Date April 06, 2020 ~ April 09, 2020
Serial No. -
Standard ISTA Procedure 2A:2011 Page 2

1) Test condition
① Anticipated conditions : Controlled conditions
② Test Temperature : 23℃
③ Test humidity : 50% R.H
④ Test time : 78h
⑤ Status of product : Packaged product
⑥ Sample quantity : 1 Box (50ea)

2) Test method
i. Test Profile

* Test graph of the chamber is presented in Appendix 1.

ii. After install specimen in the chamber. Conduct accordance with approved test plan as in “Test
profile”

3) Test equipment
Description Manufacturer&Model Serial No. Calibration date Calibration Laboratory
Chamber ESPEC/PSJ-4J 15012851 July 20, 2019 SICT

4) Test result
- Refer to page 11

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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* Appendix 1. Test graph of the chamber

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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5.2 Compression Test (2 of 5)

Manufacturer PHILOSYS Co., Ltd. Dept. in charge Production management team

Product Universal Transfer Medium Tester Lee, Song-Ha
Model Gmate® UTM
Date April 10, 2020
Serial No. -
Standard ISTA Procedure 2A:2011 Page 1

1) Test condition
① Test type : Apply and release test
② Test Force : 63.728 kgf (624.5344N)
(Test Force = [ Wt * (S-1) * F * 9.8 ] * 1.4
623.5344 ≒ [ 11.38 * (2-1) * 4 * 9.8 ] ) * 1.4
③ Test Time : 3s
④ No. of sample : 1 Box

2) Environment conditions: (27 ± 1) ℃, (36 ± 1) % R.H.

3) Test equipment
Calibration Calibration
Description Manufacturer&Model Serial No.
date Laboratory
Compression HAIDA/HB-A505S-
170801302 March 20, 2020 SICT
tester 2000

4) Compression Photograph

5) Test result
- Refer to page 11

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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5.3 Vibration Test (3 of 5)

Manufacturer PHILOSYS Co., Ltd. Dept. in charge Production management team

Product Universal Transfer Medium Tester Lee, Song-Ha
Model Gmate® UTM
Date April 13, 2020
Serial No. -
Standard ISTA Procedure 2A:2011 Page 2

1) Test conditions
① Test type : Dwell sine
② Frequency : 5 Hz
③ Displacement : 25 mm(p-p)
④ Test axis : Vertical (Z)
⑤ Test time : 48 min in total
⑥ Check time : After the test
⑦ Sample condition : Packaged product
⑧ Sample quantity : 1 Box

2) Environment conditions: (27 ± 1) ℃, (36 ± 1) % R.H.

3) Test procedures
i. Fix the bracket on the vibration table.
ii. Put the specimen on the vibration table.
iii. Operate the vibration tester.

4) Test equipment
Serial Calibration Calibration
Description Manufacturer&Model
No. date Laboratory
VIBRATION TESTING SG-
SHINKEN/G-0310L JAN 04,2020 SICT
SYSTEM 4763
SHINKEN/V-11-
ACCELEROMETER 1689 FEB 20,2020 SICT
101S

5) Test result
- Refer to page 11

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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* Appendix 1. Vibration test Data_Z axis

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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5.4 Drop Test (4 of 5)

Manufacturer PHILOSYS Co., Ltd. Dept. in charge Production management team

Product Universal Transfer Medium Tester Lee, Song-Ha
Model Gmate® UTM
Date April 16, 2020
Serial No. -
Standard ISTA Procedure 2A:2011 Page 1

1) Test conditions
① Sample weight : 11.38kg
② Drop weight : 0.81m
③ Drop orientation : 1 Corner 3 Edges 6 Faces
④ Number of drops : 10 times in total
⑤ Check time : After the test
⑥ Sample condition : Packaged product
⑦ Sample quantity : 1 Box

2) Environment conditions: (27 ± 1) ℃, (36 ± 1) % R.H.

3) Test procedures
i. Set the test height of drop.
ii. Put the specimen on drop table
iii. Perform the drop.
iv. Repeat from steps ii) to step iii) for each required surface.

4) Test equipment
Calibration Calibration
Description Manufacturer&Model Serial No.
date Laboratory
DROP TESTER DUOCOM/HS-120 - - -
STRAIGHT EDGE EAGLE/2000mm 12062537-8 JUL 31, 2019 SICT
ELECTRONIC AUG 16,
CAS/DB-150 CDYD03632 SICT
BALANCE 2019

5) Test result
- Refer to page 11

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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5.5 Vibration Test (5 of 5)

Manufacturer PHILOSYS Co., Ltd. Dept. in charge Production management team

Product Universal Transfer Medium Tester Lee, Song-Ha
Model Gmate® UTM
Date April 17, 2020
Serial No. -
Standard ISTA Procedure 2A:2011 Page 2

1) Test conditions
① Test type : Dwell sine
② Frequency : 5 Hz
③ Displacement : 25 mm(p-p)
④ Test axis : Vertical (Z)
⑤ Test time : 48 min in total
⑥ Check time : After the test
⑦ Sample condition : Packaged product
⑧ Sample quantity : 1 Box

2) Environment conditions: (27 ± 1) ℃, (36 ± 1) % R.H.

3) Test procedures
i. Fix the bracket on the vibration table.
ii. Put the specimen on the vibration table.
iii. Operate the vibration tester.
iv. Perform a final visual inspection and an operational check for the specimen

4) Test equipment
Serial Calibration Calibration
Description Manufacturer&Model
No. date Laboratory
VIBRATION TESTING SG-
SHINKEN/G-0310L JAN 04,2020 SICT
SYSTEM 4763
SHINKEN/V-11-
ACCELEROMETER 1689 FEB 20,2020 SICT
101S

5) Test result
Check list Test Result
1. Visual inspection
- Mechanical damage such a deformation, No abnormal was found
separation, crack, etc.
2. Performance check
Refer to *Annex 1.
- Sterilization Validation test

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

 Doc No. PVR-019-001
Validation Report Issued date 2020.04.23

Process Name: Packaging validation Page 12 / 14

* Appendix 1. Vibration test Data_Z axis

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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Process Name: Packaging validation Page 13 / 14

Annex 1. Performance check (Swab sterilization)

1. Test Protocol
A. Put the sterilized swab in a flask with 50ml D.W.
B. After keeping the flask in water bath at 37℃±0.5℃ for 24hours, cool the flask.
C. Transfer the elusion solution to the soybean casein digest ager medium and sabouraud dextrose agar medium and
incubating the medium for 5 days.
D. After incubating, observe the growth of aerobes or fungi.

2. Test Result
Aerobes (Soybean Casein digest Agar)
Negative control Positive control

Result

No aerobes growth

Fungi (Sabouraud Dextrose Agar)

Negative control Positive control

Result

F705-02(0) Philosys Co., Ltd. A4(210x297mm)

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Validation Report Issued date 2020.04.23

Process Name: Packaging validation Page 14 / 14

No fungi growth

3. Conclusion
As a result of the microbial enumeration test of sterilized Gmate® Swab, no aerobes and fungi were observed.

F705-02(0) Philosys Co., Ltd. A4(210x297mm)