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Stability Studies, FDA, GMPs & ISO 9000,accelerated aging,stress testing,method validation protocols,material failures,degradation rates,medical device consultants,pharmaceutical consultants

 

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medical device consultants,pharmaceutical consultants,biomedical,diagnosticsSearch Our Website


 

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Develop statistically valid stress and other accelerated aging studies which can simulate real time product aging

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Recommend win-win strategy for getting total FDA cooperation and fast product approval

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Invent, design and validate laboratory test methods for completion of stability studies

We have thorough knowledge and expertise in the evaluation of plastic, metallic, glass, woven and non-woven fabric materials as well as various solutions and mixtures. These evaluations have included stability, accelerated aging and actual failure of a material or product during normal use. 

We have completed product performance studies concerning the effect of radiation, E-Beam, ethylene oxide and steam sterilizations as well as temperature, humidity, pressure, vibration and time.

We have been involved in the successful transformation of numerous faulty product designs and sub-optimally operating manufacturing processes.

Stability Studies, Accelerated Aging, Stress Testing,  Forced  Degradation

Stability studies should include some degree of  forced degradation testing, more commonly called as accelerated aging or stress testing.

Even though there are no detailed guidelines that one should follow in developing this type of testing, here are a few pointers:

1. Thoroughly understand how the product will be used and what  are the conditions of warehousing, storage before use at the distributor's/customer's sites.

2. Fundamentally understand the underlined engineering and other scientific principles that control product performance and quality.

3. Simulate in the lab "worst case scenario" conditions for a given product, and evaluate the product's performance.  Here it is very important to remember that simulations are just that: simulations; real life could be more or less different.
 

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TechnoBusiness Solutions
403 Christie Ct., Stewartsville, NJ 08886 USA
Costas B. Chantzis, CEO 

Tel.: 908.387.9276
Fax: 908.387.0447  Email
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