Overcoming Challenges in Aseptic Pharmaceuticals Manufacturing

Commentary How can pharmaceutical companies comply Annex 1 and pass a GMP audit?

2024-08-26 From Filippo Parini, Area Sales Manager of Steriline 1 min Reading Time

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The current Annex 1 poses challenges for pharmaceutical companies. The specialist for the aseptic filling of pharmaceuticals supports companies in meeting these challenges. A commentary by Filippo Parini, Area Sales Manager of Steriline.

Filippo Parini, Area Sales Manager of Steriline(Bild: stefankiefer.com) — Filippo Parini, Area Sales Manager of Steriline
(Bild: stefankiefer.com)

The new Annex 1 prescribes the regulations and standards for aseptic manufacturing, with a particular emphasis on the contamination control strategy. This core document requires all pharmaceutical companies to develop and maintain a Contamination Control Strategy (CCS), a detailed document outlining all the strategies implemented to prevent contamination of aseptic products.

Considering that humans are the primary source of contamination, it is not surprising that Annex 1 recommends significantly reducing or even eliminating human intervention in aseptic manufacturing processes. This reduction should be achieved through the use of advanced automation technologies.

Additionally, current regulations strongly recommend the adoption of isolator systems, devices that physically separate the product from the external environment and human operators, further reducing the risk of contamination.

According to current regulations, all actions or practices that can be automated must be automated. This principle drives the industry towards increasingly automated and secure solutions.

To meet these requirements, equipment suppliers such as Steriline are developing and proposing fully automated and isolated turn-key solutions. These solutions integrate robotic systems and isolators to ensure maximum protection against contamination.

In conclusion, the optimal response to make pharmaceutical companies compliant with Annex 1 appears to lie in the integration of automatic and/or robotic technologies with isolator systems, offering a winning combination for safe and efficient aseptic manufacturing. To pass a GMP audit it is mandatory that the Contamination Control Strategy document is updated and periodically reviewed.

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