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STUDY PLAN

STUDY TITLE
TSEST FOR STERILITY ON PRODUCT - 20 mm FLIP-OFF SEAL; GREEN (GN-16).

TEST GUIDELINE (S): ISO 11737-2:2019

STUDY NO.: ST-G0010-21P

STUDY CODE: ST

SPONSOR
Autofits Packaging Pvt. Ltd.
D-3, M.I.D.C., Malegaon Ind. Area,
Sinnar, Nashik - 422113.
Maharashtra, India.
www.autofits.com

SERVICE PROVIDER
Medzus Healthcare Private Limited
Office-7, Ganga Heights,
Pathardi Road,
Nashik, 422010,
MH, India.
www.medzus.co.in

TEST FACILITY
Synergy Sterilisation (M) Sdn Bhd,
a STERIS Company (512058-V)
Plot 203, Kuala Ketil Industrial Park,
09300, Kuala Ketil, Kedah,
Malaysia.
www.steris-ast.com

Page 1 of 9
CONFIDENTIAL
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TABLE OF CONTENTS

1. STUDY DETAILS....................................................................................................... 3

1.1 Overview .................................................................................................................. 3

1.2 Study Responsibilities............................................................................................. 3
1.3 Proposed Study Schedule*...................................................................................... 3
1.4 Sponsor Details ........................................................................................................ 3

2. QUALITY ASSURANCE............................................................................................. 4

3. STUDY COMPLIANCE .............................................................................................. 4

4. STUDY GUIDELINES ................................................................................................ 4

5. SAFETY PRECAUTIONS ........................................................................................... 4

6. OBJECTIVE OF STUDY ............................................................................................. 4

7. PRINCIPLE OF STUDY ............................................................................................. 4

8. MATERIALS .............................................................................................................. 4

8.1 Test Item Information ............................................................................................. 4

8.2 Equipments & Material ........................................................................................... 5
8.3 Environmental Test Conditions ............................................................................. 5
8.4 Sample Size .............................................................................................................. 5

9. TEST PROCEDURE ................................................................................................... 5

10. ACCEPTANCE CRITERIA ......................................................................................... 5

11. AMENDMENTS AND DEVIATIONS ......................................................................... 5

12. STUDY PLAN AND REPORT DISTRIBUTION ......................................................... 6

13. ARCHIVING .............................................................................................................. 6

14. STUDY REPORT ....................................................................................................... 7

15. STUDY PLAN APPROVAL ........................................................................................ 8

Annexure 1. Test Item Information Sheet ......................................................................... 9

ST-G0010-21P Study Plan Page 2 of 9

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1. STUDY DETAILS
1.1 Overview
Study Title : Test for sterility on product - 20 mm flip-off seal; Green (GN-16).

Study Number : ST-G0010-21P

Study Code : ST

Sponsor : Autofits Packaging Pvt. Ltd.

D-3, M.I.D.C., Malegaon Ind. Area,
Sinnar, Nashik - 422113.
Maharashtra, India.

Service Provider : Medzus Healthcare Private Limited

Office-7, Ganga Heights,
Pathardi Road,
Nashik, 422010, MH, India.

Test Facility : Synergy Sterilisation (M) Sdn Bhd,

a STERIS Company (512058-V)
Plot 203, Kuala Ketil Industrial Park,
09300, Kuala Ketil, Kedah,
Malaysia.

1.2 Study Responsibilities

Technical : Mr.
Analyst-I : Mr.
Analyst-II : Mr.
QA : Mr.

1.3 Proposed Study Schedule*

Study Initiation Date : XX/XX/XXXX
Experiment Start Date : XX/XX/XXXX
Result Recording Date : XX/XX/XXXX
Experiment Completion Date : XX/XX/XXXX
* Actual date will be mentioned in Final Report.

1.4 Sponsor Details

Sponsor Representative
: Mr. Suveeth Kumar
Autofits Packaging Pvt. Ltd.
D-3, M.I.D.C., Malegaon Ind. Area,
Sinnar, Nashik - 422113.
Maharashtra, India.

Monitoring Scientist : Mrs. Leena More

Autofits Packaging Pvt. Ltd.
D-3, M.I.D.C., Malegaon Ind. Area,
Sinnar, Nashik - 422113.
Maharashtra, India.

ST-G0010-21P Study Plan Page 3 of 9

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2. QUALITY ASSURANCE
The Quality Assurance Unit personnel of Medzus Healthcare Private Limited will
inspect at different phases of the study and reviews the draft and final study
plans, draft and final reports to assure the integrity of study in compliance with
ISO/IEC 17025:2017.

3. STUDY COMPLIANCE
This study will be conducted in compliance with Quality Management System as
per ISO/IEC 17025:2017.

4. STUDY GUIDELINES
This study will follow below guidelines-
 ISO 11737-2:2019- Sterilization of health care products — Microbiological
methods — Part 2: Tests of sterility performed in the definition, validation
and maintenance of a sterilization process.
 EN ISO 11737-2:2009- Sterilization of health care products —
Microbiological methods — Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization process (ISO 11737-
2:2009).

5. SAFETY PRECAUTIONS
All necessary safety measures will be taken care during the conduct of the study.
When required, personnel involved in the study shall wear gloves, head cap and
facemask in addition to the protective clothing to ensure adequate personnel
health and safety.

6. OBJECTIVE OF STUDY
The objective this study is to evaluate the sterility of product - 20 mm flip-off
seal; Green (GN-16).

7. PRINCIPLE OF STUDY
Sterility testing of product is typically performed using media called SCDM
(Soybean-Casein Digest Medium). The test item is aseptically placed in the
sterile growth media. The inoculated test item requires incubation at 30±2°C for
14 days. If the media has turned turbid after fourteen days, the sample has failed
the sterility test.

8. MATERIALS
8.1 Test Item Information
The test item information provided by the sponsor as per Test Item information
Sheet (TIIS) is furnished as below:
Name of the Test Item : 20 mm flip-off seal; Green (GN-16)
Test item Code by Sponsor : NA
Name to be used in Report : 20 mm flip-off seal; Green (GN-16)
Test Item Code by Test Facility : NA
Batch No./Lot No. : 279,08,20 (A)
Date of Manufacture : 07/05/2021
Date of Expiry : 06/05/2025
Storage Conditions : Ambient (21 to 29°C)
ST-G0010-21P Study Plan Page 4 of 9
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The Sponsor is responsible for authenticity of the test item and no further
characterization of test item will be performed at Medzus Healthcare Private
Limited. Test item information provided by the sponsor in Test Item Information
Sheet.

8.2 Equipments & Material

No. Item
1 Laminar Air Flow
2 Incubators
3 Soyabean Casein Digest Medium (SCDM)
4 Peptone Water
5 B subtilis -Subculture

8.3 Environmental Test Conditions

Tests will perform at a temperature within the range of 15 °C to 25 °C and at a
relative humidity between 25 % and 65 %.

Environment for Sterility Test: According to ISO 11737-1, sterility test will
conduct under aseptic conditions in controlled environments as indicated in ISO
14644, such as under a laminar air flow in an assigned room.

8.4 Sample Size

10 Numbers of 20 mm flip-off seal; Green (GN-16) will use to assess the sterility
of product.

9. TEST PROCEDURE
Tests shall performed as per-
a. Each sample should aseptically immerse separately in previously sterilized (at
1210C) 200 ml of Soyabean Casein Digest Medium.
b. Incubate the test item inoculated tubes at 30±2°C for 14 days
c. Similarly, Negative control & positive control tubes incubates at above condition.
d. Observe the tubes daily during incubation period for evidence of microbial
growth (presence of turbidity and/or growth). The presence of growth and or
turbidity results in failure of sterility in the product.
e. Positive control should show satisfactory growth.
f. Negative control should not show any growth.

10. ACCEPTANCE CRITERIA

When tested in accordance with ISO 11737-2: 2019; the product inoculated
medium should not show growth and or turbidity.

11. AMENDMENTS AND DEVIATIONS

The study will be conducted as per the mutually agreed and approved study plan
with the sponsor. The amendments / deviations if any occur during study period
will be mentioned in the study report.

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12. STUDY PLAN AND REPORT DISTRIBUTION
The original Study Plan and Study Report will be distributed between Sponsor
and Test Facility as follows:

Study Plan
a) Copy No. 1/2 – Sponsor.
b) Copy No. 2/2 – Archives,
Study Report
a) Copy No. 1/2 – Sponsor.
b) Copy No. 2/2 – Archives,

13. ARCHIVING
All study related records, study plan, and final report will be maintained in the
archives of Medzus Healthcare Pvt. Ltd. for 1 year from the date of the
completion of the study, all the records will be handled according to
ISO/IEC17025;2017 Management System. After the completion of archiving
period, the test facility management will co-ordinate with the sponsor for further
course of action on archived material.

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14. STUDY REPORT
Final study report will include, but not limited to the following information:
 Study Schedule
 Quality Assurance Statement
 Identification of Study
 Test Item details
 Test System details
 Materials and test methods
 Result and Conclusion
 Incubation Time
 Incubation Temperature
 Growth Observation

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15. STUDY PLAN APPROVAL
The Study Plan for the Study No: ST-G0010-21P, entitled – “Test for sterility on
product - 20 mm flip-off seal; Green (GN-16).” has been mutually agreed and
approved.

For Medzus Healthcare Private Limited (Service Provider):

Mr. Rahul R. Patil.

_____________
Technical Manager
(Sign & Date)

Mrs. Neha Patil.

______________
QA-Manager
(Sign & Date)

Ms. Madhuri Patil.

______________
QC-Manager
(Sign & Date)

For Autofits Packaging Pvt. Ltd.:

Mr. Suveeth Kumar _____________

Sponsor Representative (Sign & Date)

Mrs. Leena More _____________

Monitoring Scientist (Sign & Date)

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Annexure 1. Test Item Information Sheet

ST-G0010-21P Study Plan Page 9 of 9