Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.

Sponsored Content

Fulfilling Annex I in Sterile Drug Production: When to Use Automatic Loading and Unloading Systems for Freeze Dryers
Fulfilling Annex I in Sterile Drug Production: When to Use Automatic Loading and Unloading Systems for Freeze Dryers

Sterile drug production has always been a challenging task to perform in the pharmaceutical industry. There are many requirements to fulfill: to assure product quality, to protect the operator when potent compounds are present, to achieve high levels of efficiency,.…. And all of them must comply with the existing pharmaceutical regulations. In Europe, the main directives to follow are 2001/83/EC and 2017/1572. Annex I of these guidelines for CGMPs was modified in 2022 and it has agitated the sector as human intervention is explicitly not accepted at all under class A conditions. This article will analyse how to address these challenges in different scenarios.

Download Sponsored Content

To download this sponsored content, complete the form below. Once submitted, you will receive a link via the email you provided to download the sponsored content.

Company Type

By completing this form, you consent to have your information provided to the third-party sponsor of this content and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you . ISPE will store your information in a secure environment and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Facilities & Equipment Product Development
Sterile Prd