Biorad Medisys Pvt. Ltd.

Survey No. 48/3 & 48/7, Pashan-Sus Road, Sus Village, Tal.
Mulshi,Pune-411021 Maharashtra, India
VALIDATION PROTOCOL FOR TRANSPORTATION TEMPERATURE
FOR GASTRO PRODUCTS
Doc No. 504-TTVP-GEP-00 Revision No 00 Effective Date

1. BACKGROUND: The products travel from Pune to various part and uses air and goes to countries
where the temperature is sub-zero.

2. SCOPE

2.1. This study is being done for gastro products which are likely to be subjected to sub zero
temperature during dispatch and transportation.

2.2. Transportation temperature we propose to claim is -10 0C to +45 0C.

2.3. This protocol need not have scope to test these products at +45 0C because aging studies are
being carried out for Gastro products having already subjected to +60 0C and hence the success of
aging is itself a rationale and justification for the product to withstand high temperature up to
+600C for cumulative period of 3 months at +600C.

2.4. But our claim for transportation will be limited to +45 0C and for short time. Hence this
transportation temperature protocol is logical and fitting to our requirement since the upper
limit of temperature is tested separately.

3. RATIONALE

3.1. These products are subjected to temperature below 0 0C for short term and the cumulative time
is not expected to exceed a weak.

3.2. Hence our study at subzero temperature will be done at -15 0C for 15 days (15 x 24hr). This is 50C
lower than proposed claim and it is 8 days more than the average transportation cumulative
time.

4. PROCEDURE

4.1. Pack each of the product as per its packing configuration and carry out ETO sterilization of the
product in validated Sterilization chamber.

4.2. Keep all the products in a shipper carton with identification list of the products and put a
temperature data logger Elitech RC-5 in the shipper carton with a programmed range.

4.3. Put the samples in a deep freezer at -150C for 15 days i.e., 360 hrs.

4.4. All physical tests will be done after all the products attain room temperature, after minimum
24hrs. (Keep the shipper carton open)

4.5. Data will be downloaded from the temperature data logger Elitech RC-5. Data in the
range of -15 + 30C will be accepted.

4.6. Perform PRE validation and Post Validation testing.

Biorad Medisys Pvt Ltd Unauthorized Copying Prohibited Page 1 of 2

 Biorad Medisys Pvt. Ltd.
Survey No. 48/3 & 48/7, Pashan-Sus Road, Sus Village, Tal.
Mulshi,Pune-411021 Maharashtra, India
VALIDATION PROTOCOL FOR TRANSPORTATION TEMPERATURE
FOR GASTRO PRODUCTS
Doc No. 504-TTVP-GEP-00 Revision No 00 Effective Date

5. CONCLUSION : If all the Pre and Post validation tests pass, the product shall pass the transportation
temperature test for short period of time i.e 15 days.

6. REVISION HISTORY

Revision
Rev No Effective Date
Section No Description of change
00 10-08-2020 ALL First Issue
Approvals
Name Designation Signature Date

Prepared By Ajit Shilwant

Khushboo
Reviewed By
Warhade
Approved By Debasish Pradhan

Biorad Medisys Pvt Ltd Unauthorized Copying Prohibited Page 2 of 2