ISPE announces speakers for 2024 Aseptic Conference

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Featured speakers at the 2024 ISPE Aseptic Conference will be health representatives from Australia, Europe, and the US.

The representatives from these national regulatory agencies will discuss current issues in aseptic processing from a technical perspective and the latest developments in aseptic and sterile manufacturing.

These featured speakers will also provide clarifications and weigh in on key learnings from the initial steps towards the implementation of Annex 1.

Attendees will have the opportunity to submit questions to the panellists.

The featured speakers are representatives from the following:

  • Austrian Agency for Health and Food Safety (AGES/Austria)
  • Regierungspraesidium (RP) Tübingen in Germany
  • Swissmedic in Switzerland
  • Therapeutic Goods Administration (TGA) in Australia
  • United States Food and Drug Administration (US FDA)

The confirmed featured speakers are:

Christina Meissner, GMP Inspector at the Austrian Agency for Health and Food Safety (AGES)

Meissner said: “As a representative of the Austrian Competent Authority, I will be reporting on the status of the implementation of Annex 1.”

“There will be specific examples of best practices, but also of areas where the industry needs to improve,” Meissner continued.

 

Daniel Muller, Head of GMP Inspectorate at Regierungspraesidium (RP) Tübingen in Germany

Muller said: “As a German regulator, I will be talking about our experiences in inspections since Annex 1 came into effect in August 2023.”

Muller will be discussing the areas where RP have seen good strategies of implementation, common hurdles for implementation, and where the industry has to improve.

Maria Löflund, Site Head Manufacturing Vienna at Takeda

Löflund said: “ISPE provides a great platform for exchanging knowledge and best practices with other companies on current and important industry topics.”

“I am looking forward to the 2024 ISPE Aseptic Conference in March and the valuable discussions on aseptic processing and implications of Annex 1 changes to the industry, as well as welcoming visitors to our Takeda production site in Vienna to share insights into our technologies and processes,” Löflund added.

 

Alexander Herzog, Secretary General of PHARMIG in Austria

Herzog said: “My talk will focus on the contribution of the pharmaceutical industry in Austria to world health.”

The 2024 ISPE Aseptic Conference will bring together leading professionals from several industries including:

  • Pharmaceutical and biopharmaceutical manufacturers
  • Technology providers
  • Academic scientists
  • International regulators

Vitech works with Airbus to design innovative air recirculation system for satellite cleanroom

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Viessmann Technologies (Vitech) has completed a state-of-the-art satellite manufacturing cleanroom in Madrid for Airbus.

The modular cleanroom solutions provider was chosen for the completion and commissioning of the new cleanroom, and it was executed in order to make the area ready for its qualification and handover.

The new build was completed in Getafe, close to Spain’s capital city Madrid.

Vitech encountered some specific challenges along the course of the build. These hurdles were the result of the need for 15m high ceilings, set levels of recirculation, and a short lead time.

The cleanroom needed to have a 15m ceiling. Therefore, Vitec installed more than 3000 sqm of ceiling grid system at over 15m. This area of wall and ceilings then had to be sealed to ensure tightness and correct pressure. “Panels for sound absorption have been added into the ceiling to minimise the noise from the complete ventilation system,” the company added.

The room also now contains six personnel airlocks with air showers, cleanroom doors and a conductive cleanroom floor.

The wall, floor, and ceiling system also integrated lights, sprinklers and exhaust air grids.

The ventilation system needed to create ISO Class 8 levels of cleanliness to meet manufacturing guidelines. Vitech worked with Airbus to design an innovative air recirculation system in order to do this.

The system is comprised of 10 recirculation units with H14 and AMC filtration systems, including adjustable flow velocity and direction.

The demands of all of these needs were compounded by a short lead time. “The project has been handed over in just over 26 weeks from the start date,” Vitech said.

LR Pure Systems chooses CAT to double its cleanroom capacity

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LR Pure Systems, a specialist in the field of high-tech solutions for ultra-high-purity gas and fluid systems, has doubled its cleanroom capacity at its site in Heimerdingen (Baden-Württemberg), Germany.

The additional ISO 6 Class cleanroom area enables the commissioning of another state-of-the-art system for cleaning components, such as those used in wafer processing or technical gas supply.

CAT Clean Air Technology supported  LR Pure Systems, its long-time partner with the implementation of this expansion project.

“The high requirements for the chemical cleanliness of the cleanroom in accordance with DIN EN ISO 14644-8 proved to be a challenge in the planning phase, and in the implementation phase above all the floor height of the existing building,” CAT Clean Air Technology said in a LinkedIn post.

“Repeatedly, pipes had to be rebuilt during ongoing production operations in order to optimally position the plenum and the filtration technology and to maintain the required height in the approximately 115 sqm cleanroom. The connection of the existing cleanroom systems also required coordination skills and flexibility from all those involved!”