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.
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