SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS – Free PDF download

Manostaxx
Manostaxx

 

http://www.manostaxx.com

 

 

 

Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. A well designed  HVAC system will also provide comfortable conditionsfor operators.

These guidelines mainly focus on recommendations for systems for  manufacturers of non-sterile dosage forms, and include tablets, capsules,  powders, liquids, creams, ointments, etc. The HVAC design principles  contained in the guidelines may be applied to other dosage forms.

HVAC system design influences architectural layouts with regard to items  such as airlock positions, doorways and lobbies.The architectural components  have an effect on room pressure, differential cascades and cross contamination control. The prevention of contamination and cross contamination is an essential design consideration of the HVAC system. In  view of these critical aspects, the design of the HVAC system should be  considered at the concept design stage of a pharmaceutical manufacturing
plant.

Temperature, relative humidity and ventilation should be appropriate and  should not adversely affect the quality of pharmaceutical products during  their manufacture and storage, or the accurate functioning of equipment.

This document aims to give guidance to pharmaceutical manufacturers.

 

Download PDF here

Continue at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC_QAS15-639_31082015.pdf

 

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:

www.manostaxx.com

 

Manostaxx
Manostaxx – Industrial Management Consulting

Leave a Reply

Your email address will not be published. Required fields are marked *