Discussing the Evolution of Aseptic Processing Equipment for Regulatory Compliance (CPHI Milan 2024)

Editor's note: this interview was originally published on PharmTech.com.

The Pharmaceutical Technology Group sat with Zaim Gashi, area sales manager, Steriline, at CPHI Milan to discuss current aseptic processing regulatory requirements and the evolution of aseptic processing equipment to stay compliant. Gashi, who joined Steriline in 2007, has held his current position since 2015. From 1992 to 2015, he built his expertise as a designer and developer of control systems, primarily within the pharmaceutical industry. This technical expertise provided a strong foundation for his current role, in which he manages agents and clients across Southeast Asia, West Balkans, Greece, and Bulgaria.

Zaim Gashi, Area Sales Manager, Steriline. Image courtesy of Steriline.

“[A]septic processing equipment has evolved following generational technological and regulatory changes and [the] development of new drugs and consumables,” Gashi stated. Evolution of aseptic processing equipment has gone “from very simple equipment with almost an existing flexibility in the past, where the biggest responsibility was on the operators, [to] [t]oday, [where] we have the most sophisticated machines equipped with artificial intelligence technology, including robots with high flexibility,” he explained. Certain operational achievements that were once within the purview of manual operators are nowadays executed by robots or devices that are manufactured using high-precision components.

“In my opinion, the driving force is the ultimate goal of fulfilling the very strict rules imposed by current regulations. We must always bear in mind that we are mostly dealing with products that are injected into human or animal bodies. Therefore, it is of paramount importance to maintain septic conditions during the entire filling and finishing process. In this context, we cannot fail to mention Annex 1 of Volume 4 of the EU [European Union] guidelines, which has become something of a holy book for professional environmental monitoring. Reducing the risk of contamination caused by operators [is among] the important [considerations],” Gashi added.

Gashi also pointed out that, though the vast majority of Steriline’s customers choose isolators as their barrier system, isolators are not mandatory, according to Annex 1; however, isolators are mentioned almost 50 times. “Robotic systems are also mentioned, and [they] are likely to play the main role in environmental monitoring and gloveless isolators. The other driving forces are new drugs and consumables, especially single-use systems and RTU [ready-to-use] containers … [these] are mostly used in case of small batches,” Gashi said.

Click above for the full interview.

Attendees can visit Steriline at Booth A42 in Hall 18. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.