Study Mode Evaluation

Ageing studies, Preclinical large animal evaluation, Blood bag study, Genotoxicity- In vivo and any other long tern studies or tests involving a large number of test material are carried out in a study mode.
Evaluations that are not regular and is tailor made to the customer usually follow a study mode which will be carried out under the responsibility of Study Director/s.
The study mode evaluations are carried out on a quality platform.
In study mode after discussion with the customer and having a initial consensus on the protocol, a study budget is intimated to the customer.
On mutual agreement on the budget the study protocol is sent to the customer.
The customer is to sent the initial payment and also the study protocol with due approval.
We always look forward to the visit of the customer to monitor the progress of the study as these are long term evaluations.
Usually large animal preclinical evaluation, blood bag evaluation, ageing studies etc are carried out under this mode.
Preclinical Large Animal Evaluation

Animals provide a valuable testing system anatomically, physiologically or even pathologically because of their phylogenetic closeness to humans. Preclinical large animal evaluation is generally conducted in order to provide a reasonable assurance of device safety prior to use in humans in a clinical trial. Relevant animal models are selected depending on the clinical application of the device.

Experience & expertise in the evaluation of critical cardiovascular & neurosurgical products and sophisticated facilities is a good advantage to us.

Expertise include evaluation of majority of the cardiovascular devices like drug eluting coronary stents, heart valve etc.

Accelerated Ageing Studies

The manufacturer must ensure the product and package system combine to create a total product that performs efficiently, safely and effectively in the hands of the user.

Accelerated aging is the storing of packages at elevated temperature and / or other intensified environmental conditions in order to simulate real time aging in a smaller duration of time. Environmental chambers are used for accelerated aging test.

The principle behind the concept of accelerated ageing is that the ageing of medical device packaging can be accelerated to two time space by increasing the storage temperature by 10oC, by what is known as Q10 analysis.

The ageing studies are carried out on the basis of the following:

• Donald S Barcan and Harold F Miller, Package Validation in Max Sherman (Ed.), Medical Device Packaging Handbook, Marcel Dekker Inc, NY, 1998, pp267-30
• The European Agency for the Evaluation of Medicinal Products. Guideline for stability testing : stability testing of existing active substances and related finished products, CPMP/QWP/122/02 rev 01 , Dec 2003