Heating, ventilation, and air conditioning (HVAC) system consumed huge energy. Especially chillers, hot water generation, boiler operation consumed lots of energy. We can understand the qualification requirement from the table 1. Loosing microbial controls is very high due to unplanned shut down. An efficient design and qualification approach can help firm for long run.
It is not advised to switch off the ventilation system completely, it is rather advised not to do it. Premises, pressure conditions, microbiology, everything would be out of control during that time. This would make the subsequent measures for the restoration of the GMP-compliant state very complex because each time a requalification would be necessary to reach the normal GMP-compliant state.
However, planned shut own need to be evaluated with risk management program and identify what are the action need to be considered during start up. And for unplanned shutdown, a detailed investigation needs to be performed to identify the all probable root causes and proper corrective and preventive action need to be implemented. Impact assessment need to be prepared to identify all the effected area.
It is not recommended to shutdown Grade B and Grade C area. In case of sterile application through any such major shutdown may need an assessment through media fill simulation.
Apart from switch off the HVAC, a cost-effective design can help sustaining your business. Below points are identified as an improvement point for new/or existing design,
Dear Readers,
This article is published understanding the current requirement as due to COVID-19 pandemic condition pharmaceutical facilities out of enough man power and resources. This article will be helpful for better understanding the requirements and will support for impact assessment. Based on the preliminary impact assessment, understanding and industrial experience author was narrated all the requirements/ actions. Assessments can be different case to case based on the input information /or criticality of product manufacturing requirements. Thank you .
Author Desk
Planning everything prior to doing it and then executing any tasks makes it easy to carry out the maintainance smoothly and successfully. Thank you for sharing the information with us through this article. This would definitely be helpful next time for planning out any task.
Saw your material, and hope you publish more soon. Rozina Linn Bone
I think this is among the most vital info for me. And i am glad reading your article. Donnamarie Blane Anna-Diana
Good post. I learn something tougher on totally different blogs everyday. It’s going to all the time be stimulating to learn content material from other writers and apply somewhat something from their store. I’d want to use some with the content material on my blog whether or not you don’t mind. Natually I’ll provide you with a hyperlink in your net blog. Thanks for sharing.
I am happy that you got some valuable information. You can use in your Blog as well. Thanks