Ravona-Pharma products are designed to conform to all applicable international standards and the

end-user requirements (URS) for overall production and quality assurance processes.

 

 

Among the standards and directives that we meet are:

 

       ISO14644-Clean room and associated control environments

 

• Part 2 –Specification for testing and monitoring to prove continued compliance with above

• Part 7 – Separative devices (clean air hoods, glove boxes, isolators, mini environments).

• Part 8 – Classification of airborne molecular contamination

•  

      ​ISO 10648 Containment enclosures

• Part 1  - Design principles

• Part 2 – Classification according to leak tightness and associated checking method.

 

       EN 294 – Safety of machinery safety distance to prevent danger zones being reached by the upper limbs.

 

      EN ISO 12100-2 Safety of Machinery,  basic concepts and general principles of design:

• Part 1  - Basic Terminology and methodology

• Part 2-  Technical principals

 

 

 

 

 

 

Ravona  is an ISO 9001-2015 quality managment certified  company.