AGEING STUDY PROTOCOL FOR Doc No.

: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

Aging Study Protocol for Auto disable Syringe (Early

Activation) for Fixed Dose Immunization with Attached
Needle 23Gx1” (0.5ml 3 Piece)
(Protocol No.: RHEL/ASP/06-0.5/3)

Document information, authorship and approvals

Prepared by Job Title: Signature: Date:
Sheillah Bett QC Assistant 01/01/2022

Reviewed by: Job Title: Signature: Date:

Fridah Jepkorir QA Assistant 01/01/2022

Approved by: Job Title: Signature: Date:

Vikrant chowgule Quality Head 01/01/2022

1.0 PURPOSE

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

The purpose of the stability study is to establish the shelf life and label storage instructions
applicable to all future batches of the product manufactured and packaged under similar
circumstances. The degree of variability of individual batches affects the confidence that a
future production batch will remain within specification throughout its shelf life. The study is
applicable for both real time condition and accelerated condition aging studies.

2.0 SCOPE
The scope of this protocol is limited to the Auto Disable Syringe (Early Activation) for Fixed
Dose Immunization with Attached Needle 23Gx1” (0.5ml 3 Piece) product for its shelf life (5
Years) manufactured at Revital Healthcare (EPZ) Limited, Kenya facility. REMI Stability
Chambers Capacity 1000 liters M/C No. LAB/INST/46
3.0 REFERENCES

3.1. ASTM F1980—21: Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices.
3.2. EN ISO 11607-1: 2020 Packaging for terminally sterilized medical devices.
3.3. ICH Guideline on Stability Studies (ICH Q1)
3.4. ISO 7886:3 2020 Auto disabled syringes for fixed dose immunization

4.0 ABBREVIATIONS:
4.1. BET: Bacterial Endotoxin Test
4.2. CAPA: Corrective Action/Preventive Action
5.0 RESPONSIBILITY
5.1. Quality Control
5.1.1 Is responsible for the withdrawal of the sample as outlined in the protocol.
5.1.2 Is responsible to perform testing as per protocol.
5.1.3 Is responsible to prepare report after completion of study then review the report
with Supervisor and manager and get it approved from QA.
5.2 Manager QC
5.2.1 Is responsible to evaluate protocol for accuracy, functionality and assignment of
responsibilities.
5.2.2 Is responsible to review the protocol.
5.3 Manager QA
5.3.1 Is responsible to approve the protocol.
5.3.2 To ensure that the procedure outlined in the protocol is followed.

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

6.0 PRODUCT DETAILS

Sr. No. Product Name
Auto Disable Syringe for Fixed Dose
1 PRODUCT NAME Immunization(Early Activation) with Attached Needle
23Gx1” (0.5ml 3 Piece)
2 LOT NO. 220201 226005 226105
3 MFG. DATE 22.01.02 22.05.12 22.05.13

4 EXP. DATE 27.01.01 27.05.11 27.05.12

5 STERILISATION ETO ETO ETO

7.0 MATERIAL DETAILS
Sr. No. Component Name Material used Grade

1. Barrel and plunger Polypropylene RG568MO

2. Gasket Natural TPE 3250-01

3. Ink for graduation Black pigment UN1210

Adhesive Epoxy DHUV-7933T
4.
Cannula Stainless steel SS 304
5.
Stainless steel clip Stainless steel SS 304
6.

8.0 SAMPLE QTY. TO BE KEPT (AS PER SAMPLING PLAN)

Condition Total Sample Qty.

Accelerated (Condition (A))
Temperature: - 59±10C 400 Pcs per Lot
Humidity: - 60%±5%
Real time (Condition (B)) 2,000 Pcs per Lot
Temperature: - Room Temperature
Humidity: - 60%±5%

9.0 SAMPLE QTY.TO BE WITHDRAWN AT EACH INTERVAL

Time interval
Condition (A)
Initial 12th week 24th week
0
Accelerated: 59±1 C 100 Pcs 100 Pcs 100 Pcs

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO DISABLE
SYRINGES

Batch No. 220102

Time interval
st
Condition (B) 1 48th 60th 61st
Initial 3rd 6th 12th 18th 24th 36th
Month Month Month Month
Month Month Month Month Month Month
Real Time; 100 100 100 100 100 100 100 100 100 100 100
Room Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs
Temperature

Batch Nos. 226005 and 226105

Time interval
Condition (B) Initial Initial Initial Initial Initial Initial Initial Initial Initial Initial Initial

Real Time; 100 100 100 100 100 100 100 100 100 Pcs 100 100
Room Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs Pcs
Temperature

10.0 STORAGE CONDITION

Storage Condition Temp. Condition Total time of study Test intervals

Temperature. 59 ± 10C
Accelerated Humidity. 60% ± 5% 24 Weeks 03

Room Temperature
Real Time Humidity. 60% ± 5% 61 Months 11

11.0 TESTING REQUIREMENT

For testing of samples, follow the product applicable standards, Finished Product Specification and Test methods of
Revital Healthcare (EPZ) limited.

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

12.0 TESTING REQUIREMENT

A. FOR ACCELERATED TIME CONDITION
Start Date: 13/05/2022

LOT No.: 220201 Mfg. Date: 22.01.02 Exp. Date: 27.01.01 Lot Size: 720,000 Pcs.
LOT No.: 226005 Mfg. Date: 22.05.12 Exp. Date: 27.05.11 Lot Size: 720,000 Pcs.
LOT No.: 226105 Mfg. Date: 22.05.13 Exp. Date: 27.05.12 Lot Size: 720,000 Pcs.

Number of Samples used: 400 Pieces per lot

PRODUCT DESCRIPTION: Auto Disable Syringe for Fixed Dose Immunization with Attached Needle
23Gx1”(0.5ml 3 Piece) packed and sealed in a medical grade Blister film with medical grade paper.The
Syringe Barrel and plunger is made up of polypropylene( P.P), gasket is of Natural TPE and the needle is
made up of stainless steel. The Syringe is sterile, non-toxic, non pyrogenic and is sterilized by Ethylene
Oxide Gas.
Three Months Data Compilation at Temp.: 59 ±1oC
100 pieces of each batch will be sampled for finished product analysis as in the timeline specified below;

No. of samples used Result Result Result

(Initial) (12 weeks) (24 weeks)
(n) 13/05/2022 10/08/2022 12/11/2022

The test results will be provided in the finished product analysis report (syringes) Doc. No. Z/F/07/253
(Annexure I)

B. (i) FOR REAL TIME CONDITION

Start Date: 03/01/2022

LOT No.: 220201 Mfg. Date: 22.01.02 Exp. Date: 27.01.01 Lot Size: 720,000 Pcs.

Number of Samples used: 1,500 Pieces per lot

PRODUCT DESCRIPTION:
Auto Disable Syringe for Fixed Dose Immunization with Attached Needle 23Gx1”(0.5ml 3 Piece) packed
and sealed in a medical grade Blister film with medical grade paper.The Syringe Barrel and plunger is
made up of polypropylene( P.P), gasket is of Natural TPE and the needle is made up of stainless steel.
The Syringe is sterile, non-toxic, non pyrogenic and is sterilized by Ethylene Oxide Gas.

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

Eleven Months Data Compilation Results at Room Temperature

100 pieces of each batch will be sampled for finished product analysis as in the timeline specified below;
No. of
1st 6th 12th 18th 24th 36th 60th 61st
samples Initial 3rd Month 48th month
Month Month month month month month month month
used
n
03/01/22 03/02/22 03/04/22 03/07/22 03/01/23 03/07/23 03/01/24 03/01/25 03/01/26 03/01/27 03/02/27

The test results will be provided in the finished product analysis report (syringes) Doc. No. Z/F/07/253
(Annexure II)

(ii)FOR REAL TIME CONDITION

Start Date. 14/05/2022

LOT No.: 226005 Mfg. Date: 22.05.12 Exp. Date: 27.05.11 Lot Size: 720,000 Pcs.
LOT No.: 226105 Mfg. Date: 22.05.13 Exp. Date: 27.05.12 Lot Size: 720,000 Pcs.

Number of Samples used: 1,500 Pieces per lot

PRODUCT DESCRIPTION:
Auto Disable Syringe for Fixed Dose Immunization with Attached Needle 23Gx1”(0.5ml 3 Piece) packed
and sealed in a medical grade Blister film with medical grade paper.The Syringe Barrel and plunger is
made up of polypropylene( P.P), gasket is of Natural TPE and the needle is made up of stainless steel.
The Syringe is sterile, non-toxic, non pyrogenic and is sterilized by Ethylene Oxide Gas.
Eleven Months Data Compilation Results at Room Temperature
No. of 61
1st 3rd 12th 18t 24th 36th 48th 60t
samples Initial 6th Month h h st
Month Month month month month month month month
used month
n 14/05/22 14/06/22 14/08/22 14/11/22 14/05/23 14/11/23 14/05/24 14/05/25 14/05/26 14/05/27 14/06/27

100 pieces of each batch will be sampled for finished product analysis as in the timeline specified below;

The test results will be provided in the finished product analysis report (syringes) Doc. No. Z/F/07/253
(Annexure III)

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 AGEING STUDY PROTOCOL FOR Doc No.: Z/F/07/328
Issue Date: 01/09/2021
STERILE HYPODERMIC RE-USE Rev. No.: 00
PREVENTION FEATURE/AUTO
DISABLE SYRINGES

13.0 Accelerated aging Time

The Accelerated Aging Time equivalent to real time aging shall be derived by the following formula:
2 = AA study factor
7 = Week in days
For example:
a. Reuse Prevention Syringe, Shelf Life: 5 Years
b. Real Time Temp.:240C
c. Accelerated Aging Temp.:590C
Accelerated Aging Time in Week: (Desired shelf life in days / (2^ ((AA Temp.− RT Temp)/10)))/7.
Accelerated Aging Time in Week: =1825/ [2^ (59-24)/10]/7= 23.044week
Equivalent to 24Weeks.

14.0 Remark:
A systematic approach will be adopted for the evaluation of the stability information, which includes
results from the visual, dimensional and performance tests. The data at each time frame will be evaluated,
analyzed and the same will be reported in the report for this protocol.

In case of any deviations or unexpected failures in the test results, the same will be investigated with
proper CAPA after consultation with QA section.

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