UTM - Packaging Process Validation

Doc No.
PVR-019-001
Validation Report Issued date 2020.04.23
Process Name: Packaging validation Page 1 / 14
□ Managed document (Team: )

□ Non-managed document
Item Created by Reviewed by Approved by
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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)

Doc No. PVR-019-001
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

Doc No. PVR-019-001
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

Doc No. PVR-019-001
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

Doc No. PVR-019-001
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

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* Appendix 1. Test graph of the chamber

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5.2 Compression Test (2 of 5)

Model Gmate® UTM
Date April 10, 2020
Serial No. -
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

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5.3 Vibration Test (3 of 5)

Model Gmate® UTM
Date April 13, 2020
Serial No. -
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
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

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* Appendix 1. Vibration test Data_Z axis

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5.4 Drop Test (4 of 5)

Model Gmate® UTM
Date April 16, 2020
Serial No. -
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
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

Doc No. PVR-019-001
5.5 Vibration Test (5 of 5)

Model Gmate® UTM
Date April 17, 2020
Serial No. -
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
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

Doc No. PVR-019-001
* Appendix 1. Vibration test Data_Z axis

Doc No. PVR-019-001
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

Doc No. PVR-019-001
No fungi growth
3. Conclusion
As a result of the microbial enumeration test of sterilized Gmate® Swab, no aerobes and fungi were observed.

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Doc No.

Process Name: Packaging validation Page 1 / 14

□ Managed document (Team: )

Item Created by Reviewed by Approved by

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

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

Process Name: Packaging validation Page 2 / 14

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

Process Name: Packaging validation Page 3 / 14

2.2 Related document

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

Process Name: Packaging validation Page 4 / 14

4.1 Operating test

4.2 Non-Operating Test

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

Process Name: Packaging validation Page 5 / 14

5 Test Condition & Test Result

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

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

Process Name: Packaging validation Page 6 / 14

* Appendix 1. Test graph of the chamber

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

Process Name: Packaging validation Page 7 / 14

5.2 Compression Test (2 of 5)

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

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

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

Process Name: Packaging validation Page 8 / 14

5.3 Vibration Test (3 of 5)

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

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

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

Process Name: Packaging validation Page 9 / 14

* Appendix 1. Vibration test Data_Z axis

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

Process Name: Packaging validation Page 10 / 14

5.4 Drop Test (4 of 5)

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

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

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

Process Name: Packaging validation Page 11 / 14

5.5 Vibration Test (5 of 5)

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

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

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

Process Name: Packaging validation Page 12 / 14

* Appendix 1. Vibration test Data_Z axis

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

Process Name: Packaging validation Page 13 / 14

Annex 1. Performance check (Swab sterilization)

Fungi (Sabouraud Dextrose Agar)

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

Process Name: Packaging validation Page 14 / 14

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

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