Custom solution for your bulk sterile manufacturing
FULLY-AUTOMATED
PERSONNEL PROTECTION
ASEPTIC PROCESS
Challenges with bulk sterile powder
Several types of containers
Comecer solutions for Bulk API Powder Aseptic Handling and Filling in Pharma are compatible with all different types of containers.
RTP bag
Bottle shaped bag
PE keg
alu keg
Isolator or RABs?
An ISOLATOR is a barrier systems well defined (physical) that can be validated to provide significant risk reduction of bio-contamination. An isolator provides an uncompromised, continuos, Grade A isolation of its interior from the surronding environment.
A RABS is a combinations of physical and aerodynamic barrier over the aseptic process zone. RABS is an alternative contamination control methodology designed to be used in a higher classification cleanroom (EU Grade B – ISO 7 minimum) and based on systems of less engineering complexity.
Why Comecer prefers the isolator?
Given the complete separation between the operators and the aseptic area, the isolator solution is more likely implemented together with a certain level of automation when the batch sizes are significant. Same when the API has in some extent containment need the solution with isolator is a must. On the other hand RABs can be adopted when an extremely manual operation is carried out and no issue of containment is involved.
Process ad hoc design
All the Bulk Sterile processes have many aspects in common, however every applications has its own specific requirements and constraints.
For this reason Comecer re-designs the system configuration ad hoc integrating newly conceived solutions to already adopted functional modules.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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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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