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Dr. D. Prabhakaran, second from right, and associates with Teledyne Hanson’s DB6 manual diffusion system

Testimonial by D. Prabhakaran, PhD, Master of Pharmacy, Vice President of Operations for In Vitro Research Solutions Pvt. Ltd., Bengaluru, India.

As a Contract Research Organization, iVRS does in vitro release testing (IVRT) and in vitro permeation testing (IVPT).

During IVPT, many research papers suggested full media replacement. We wanted to evaluate the impact of partial media replacement for the same study and obtain the results for IVPT.

We have used Teledyne Hanson’s DB6 manual diffusion system in IVPT applications, using the partial aliquot sampling withdrawal method, thereby avoiding the need for full media replacement, since 2019. We found that Teledyne Hanson’s DB6 manual diffusion system produced results that were well within limits and reproducible.

We have completed the study using partial replacement, i.e., aliquot sampling and replacement of withdrawn solution, instead of doing full media replacement. The results obtained for the particular product we have worked on are satisfactory and meet the regulatory requirements for its intended purpose.

Hanson’s DB6 manual diffusion system is upgraded to consider the challenges inherent in a water bath system. It has a rugged build and is one of the more precise instruments available for IVRT and IVPT applications.

The DB6 provides a more precise temperature from cell to cell, volumetric accuracy of all the cells is very precise, and it features ease of use for sampling as well as sample application. The software is user-friendly, with full 21CFR part 11 compliance, and the company provides prompt service and application support.

 

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