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Packaging for non sterile product

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Arunkumar Created:   Oct 14, 2021 Last commented:   1h ago

Packaging for non sterile product

What is the requirements of managing a  flow of the process for non steriled category? we don't fall in the cleanroom criteria.we need just follow the controlled environment. Only problem is packaging outside the assembly line .so is it ok (or) will have to go for civil change. we primary packaging as polythin . we are mechanical ventilator manufacture with non sterile .

 

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić 1h ago

The type of medical device determines the conditions under which it must be manufactured. This is not prescribed anywhere. So it is up to the manufacturer to set requirements for environmental conditions in production. In ISO 13485: 2016, requirement 6.4.1 states that manufacturers must document requirements for the work environment need to achieve conformity of product requirements, especially if conditions may affect product quality.

From your example, you need to define what is controlled environment, how you will prove that these criteria for a controlled environment are met. For example, it can be temperature monitoring, humidity monitoring, regular cleaning process, disinfection, microbiological cleanliness of premises, and so on.

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Oct 14, 2021

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