Ref No.

:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

Prepared by: (Initiator) Verified by: (QA Validation)

_____________________________________ _________________________________
(Name/Sign & Date) (Name/Sign & Date)

A) RAW MATERIALS, COMPONENTS & PACKAGING MATERIALS DESCRIPTION

No. Part/Component Material Description/Specification Material/Part No.

1 Balloon and shaft CTO3 Latex Amber C11002
2 Valve Hard Valve (Bespak Bk 333053s) D20000
3 Rubber sleeve Coloured Rubber Sleeve D21008
D24001
4 Marking material Thinner A, Ink Maraflex
d24003
5 Silicone treated coating Silicone Fluid 100cs D22002
6 Adhesive Glue Adhesive S172b, Methylene Chloride S172b D01300, D01501
7 Inner bag LDPE INNERBAG 43MM D40010
8 Top Web TOP WEB 60GSM W RUSCH D41433A
9 Base Web BASE WEB DS120 FILM DE4151

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

B) SAMPLING AND TEST PLAN:

Acceptance Criteria & Quantity Samples Required
No. Test Description Acceptance Criteria
Test Method Reference *Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Visual Inspection
Shall meet the requirement defined. QAS-008
( Dimension
1 Minimum OL 360mm EN1616:1997 N/A N/A N/A
measurement OD &
OD 5.3-0.33+0.33
OL)
When tested accordance with the N/A
Security of Drainage method given in annex B, the
2 EN1616:1997 N/A N/A
funnel drainage funnel shall not part from
the test connector.
The minimum force at break shall be N/A
given as in Table 2 EN 1618: 1997 EN1618:1997
3 Security of Connector N/A N/A
Specification Outer Diameter (OD): EN1617:1997 60 60 60
OD >4mm = 15N
When tested per Annex B, Force at N/A
break shall be more than 20N or until EN1618:1997
4 Tensile Properties N/A N/A
specified force is applied for catheter EN1617:1997
outer diameter more than 4mm.
As per test procedure in N/A N/A N/A
Visual Inspection on Packaging seal shall not have any
5 PTM 002, ASTM
packaging seal seal defect
F1886M
Package shall not show any sign of As per test procedure in N/A N/A N/A
6 Bubble leak test
leak PTM 002, ASTM D2096
Colored water leak Package shall not show any sign As per test procedure in N/A 60 N/A 60 N/A 60
7
test leak PTM 002, ASTM F1929
8 Seal strength test Seal strength value 2.54N As per test procedure in N/A 60 N/A 60 N/A 60
PTM 034, ASTM
This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

F88/F88M

Total Sample N/A 180 N/A 180 N/A 180

Grand Total Sample

NOTE:
1) Validation no: X-13-007
2) The product only consist one size CH 16.

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

C) TEST RESULT:

Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
Visual Inspection Shall meet the
( Dimension requirement defined.
1
measurement OD & Minimum OL 360mm
OL) OD 5.3-0.33+0.33
When tested accordance
with the method given in
Security of Drainage
2 annex B, the drainage
funnel
funnel shall not part from
the test connector.
The minimum force at
break shall be given as in
Security of Table 2 EN 1618: 1997
3
Connector Specification Outer
Diameter (OD): OD >4mm
= 15N
4 Tensile Properties When tested per Annex B,
Force at break shall be
more than 20N or until
specified force is applied

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

C) TEST RESULT:

Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
for catheter outer diameter
more than 4mm.
Visual Inspection on Packaging seal shall not
5
packaging seal have any seal defect
Package shall not show
6 Bubble leak test
any sign of leak
Colored water leak Package shall not show
7
test any sign leak
Seal strength value
8 Seal strength test
2.54N

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size
Disposition (Pass/Fail)

Recorded by (Sign/Date):

Verified by (Sign/Date):
(QA-Validation)
Verified by (Sign/Date):
(QA Director/Manager)
Verified by (Sign/Date):
(RA Manager)
Verified by (Sign/Date):
(R&D Manager)
Verified by (Sign/Date):
(VS Director/Manager)
Comments/Remarks:

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia
 Ref No.:_________ Page ____of____

REAL TIME AGING STUDY RECORD FORM

Product Name: Size: Sterility: Product Code: Manufacturing Date: Expiry Date:
HYDROSTATIC CATHETER 16CH Gamma
FOR BLADDER Sterile Lot No: Start Date: End Date:
DISTENSION, STERILE
Reason for Study:
1. To verify the performance of the product and packaging in real time aging. (Legacy product)
2. To verify the performance of product after colorant specification upgrade from supplier , material Colanyl Red GG130 to Colanyl
red 131, in real time aging

C) TEST RESULT:
Results
*Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
No. Test Description Acceptance Criteria
------------- ------------- ------------- ------------- ------------- --------------
Size

NOTE:
1) Record result in quantity fail/quantity tested

This document contains proprietary information. It may not be reproduced without prior written approval.
THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT
SOI-083/F1 Rev.1 Malaysia