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

 

 

 

 

 

 

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