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Validations are a “GMP” requirement of good manufacturing practice that each manufacturer identifies what validation work is necessary to prove control of the critical aspects of their particular operation.
Comecer supplies FAT (Factory Acceptance Test) protocol validation for every Hot Cell/Dispensing system/Isolator.
Comecer performs SAT (Site Acceptance Test) and supply if request IQ & OQ protocols (Installation Qualification & Operational Qualification)
The validation protocols comply to the following standards:
ISO 14644 (Cleanrooms and associated controlled Environments)
ISO 10648 (Containment enclosures)
EEC-GMP (Good Manufacturing Practice – Annex 1 Manufacture of sterile Medicinal Products)
PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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Technical Cookies
Technical cookies are technical cookies whose use does not require the user's consent. These cookies are essential to enable you to navigate a website and use its full functionality. Without these cookies, which are absolutely necessary, a website could not provide certain services or functions and browsing would not be as easy and easy as it should be. A cookie of this type is also used to store a user's decision on the use of cookies on the website. Technical cookies are essential and cannot be disabled using this feature. In general, however, cookies can be disabled completely in your browser at any time.
Statistical Cookies
Statistical cookies are used to monitor the performance of the site, for example, to know the number of pages visited or the number of users who have viewed a particular section. The analysis of these cookies generates anonymous and aggregated statistical data without any reference to the identity of the site's visitors. They are also useful to evaluate any changes and improvements to be made to the site itself.
Targeting cookies
Targeting cookies are cookies set by third parties such as YouTube, Facebook, Twitter. These cookies track your behavior such as playing videos or what tweets you have already viewed. If you do not consent to these cookies, you will not be able to watch videos on this website or use the social sharing feature. These cookies may be used by the cookie provider to create a profile of your interests and show you relevant advertisements on other sites. They do not directly store personal information but are based on the unique identification of your browser and Internet device.
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