SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES & TECHNOLOGY

BIOMEDICAL TECHNOLOGY WING

TEST MATERIAL PREPARATION & SUBMISSION

This guideline is prepared to help you understand the importance of proper “sample preparation” for the
different tests performed for the biological evaluation of materials.

It must be noted that testing is to be performed on the final product, or on representative

samples taken from the final product or from materials processed in the same manner as the
final product.

Submitting proper samples will go a long way in ensuring that you get the proper test reports in time.

We strongly advise you to visit us and discuss your testing requirements and get first hand information
on the sample requirements for the selected tests; especially if you plan to submit the test reports to
any regulatory agency.

GENERAL INFORMATION:

We conduct tests on the samples submitted by you and the test results provide results for the
test samples only. We do not certify your batch or product quality.

Our test reports will specify the test material/sample code as mentioned by you in the test request
forms. Kindly ensure that you have specified the proper sample code that will reflect your end use. If
you are submitting the test reports to a regulatory agency, ensure that the test sample codes will
provide unambiguous traceability to your material/product. We will not accept requests for change of
test sample codes or other details such as name of company etc. on the test report after testing.
General Guidelines:
Dos
1. Contact the lab and understand the specific requirements beforehand
2. Follow the specific instructions on each test request form
3. Submit samples in separately marked packets for different tests
4. When replicates are required, pack the samples in separate individual packets
5. Label the packets correctly
6. Indicate the sterilization status- whether sterile and method of sterilization
7. Indicate clearly, special storage conditions if any for your sample
8. Do indicate shelf life of samples when the sample is unstable or has a limited shelf life only
9. Do submit appropriate CONTROL samples, if required as part of the study/test.
10. If test materials are to be archived then a special request need to be given. Test materials will
be archived for a maximum of 3 years.
Don’ts

1. Do not submit samples with hazardous / infectious/ radioactive content

2. Don’t have sharp and pointed edges for your samples. Remove any burrs or sharp edges from
the sample pieces
3. Don’t submit samples before prior intimation to the customer service cell, either by post or in
person.
4. Don’t mix samples for different tests together. Pack the samples for different tests separately
5. Do not use staplers or pins on sterile packets. If sending by post/courier, ensure that there is no
damage due to stapling by the courier agency.