Our experienced in-house laboratory staff has extensive knowledge of the validation process and experience with a wide variety of products.
Validation Services
Sample Effects Studies
Sample effects studies are tests to determine the best protocol and the suitability of Celsis technology with your products. Each specific product that is sent in is tested and customized with the ideal protocol to fit your needs. Sample Effect studies are done at minimal cost to new or existing customers.
Inoculation Studies
The objective of this test is to ensure that low level contamination of a test product can be detected with the Celsis System. Low levels of pure or mixed organisms are added to the product suspension and tested to ensure detection.
Volume discounts are available to test multiple products and lots.
Regulatory Submission Services
Our regulatory department will provide guidance and information on the regulatory aspects of implementing Celsis Rapid Detection systems. The regulatory department can aid in the submission of new drug applications and answer any questions pertaining to compliance issues.
Celsis Rapid Methods are currently utilized to test a wide variety of products in manufacturing facilities worldwide. Celsis systems are recognized by regulatory agencies worldwide as a valid testing method. Celsis has made validation extremely cost effective to assist companies in taking advantage of the significant economic benefits to their companies.
