ISPE announces speakers for 2024 Aseptic Conference

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

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

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!”

MSA Safety opens Morocco PPE manufacturing facility

MSA Safety, a safety solutions company, marked the grand opening of a new Manufacturing Operations centre in Chelalate, Morocco, with an official ribbon-cutting event.

The company’s newly constructed and larger facility will be home to the production of a variety of general personal protective equipment (PPE) product lines.

The new facility will also position MSA to better meet the growing demand for MSA safety products in the Europe, Middle East and Africa (EMEA) region.

MSA Safety has had a presence in Morocco since 2002 when the company acquired CGF Gallet of France.

Jose Sanchez, MSA Safety Vice President of MissionOPS, said: “Expanding our operation in Morocco is part of our strategy to invest in regions where we’re seeing growth and a demand for our safety products. By investing in a larger facility, we’re able to optimise our manufacturing footprint to better serve key markets in the EMEA region, support our growth goals for the product lines that are currently manufactured there, and maintain a high level of customer service.”

In 2021, the Morocco team won the John T. Ryan Sr. Award for Safety Excellence. An internal award created in honour of one of the company’s co-founders, it is presented annually to the associates of an MSA manufacturing facility who show exemplary dedication to the company’s culture of safety and the MSA mission.

Bob Leenen, Senior VP and President of MSA International said: “The confidence we have in our associates and the leadership team in Morocco is why we’re investing in this location. This new facility will provide a better work environment for our growing team and enhance our ability to meet the needs of our customers throughout the region.”

ColPro Technical Solutions completes cleanroom for Unica Building Services Venlo

ColPro Technical Solutions has built a cleanroom in Katwijk (North Brabant) Netherlands on behalf of Unica Building Services Venlo.

Unica Building Services manages and maintains all building-related installations. The company coordinates the complete management and maintenance of buildings in combination with carrying out tests and inspections.

The wall panels were made in ColPro’s monoblock system on plinth construction in its factory in Almelo and installation was carried out by its own field service technicians.

Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

The panels were produced in the ColPro Technical Solutions factory in Almelo and installation was carried out by its own field service technicians and have an Advantica L-Control coating in white RAL 9010. Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

In a significant leap towards advancing cleanroom technology, ColPro Technical Solutions has recently unveiled its state-of-the-art cleanroom facility in Katwijk, Netherlands. The facility promises to be a game-changer in the realm of cleanroom solutions, catering to diverse industries with its advanced features and cutting-edge technologies.

 

CleanSpace unveils innovative new programme Clean Fit

In a strategic move to redefine the speed to market of defining and developing the Cleanroom market, CleanSpace, a prominent leader in cleanroom solutions, today unveiled its innovative programme, Clean Fit. This pioneering initiative is set to forge synergies with regional developers, aiming to showcase the advanced design and functionality of a CleanSpace cleanroom within buildings that are presently on the lease market.

“Clean Fit is designed to make it easier for life science companies to visualize and achieve their ideal production environment,” said Glenn VandeGrift, President of CleanSpace. “Our partnership with developers not only facilitates this visualisation but also significantly reduces the financial barrier to entry for these companies, ensuring a smoother start-up phase.”

Through Clean Fit, prospective tenants, particularly those interested in spaces of 5,000 sqft or more, are provided with complimentary Basis of Design (BOD) drawings, test fit drawings, and initial construction sets. This value-added service is intended to save tenants substantial amounts of time and costs, thereby sustaining their cash flow during the crucial phase of establishment.

“Our vertically integrated approach is what sets CleanSpace apart,” said CEO George Wiker. “We manage every aspect from design to installation, which means our clients benefit from our efficiency and expertise. The Clean Fit program exemplifies our dedication to providing comprehensive solutions that meet the complex needs of the life sciences industry.”

Currently, there are two showcase cleanrooms under construction, located in Houston, Texas, and within the Historic Curtis Building in Philadelphia, PA. These strategic locations are expected to open for tours prior to the conclusion of 2023, marking a significant milestone in providing access to CleanSpace’s cutting-edge cleanroom technologies.

Board Advisor Ralph Melfi added: “By expediting the process of cleanroom integration for our clients, we’re not just accelerating their production timelines—we’re facilitating the advancement of critical therapies and products to the market. Clean Fit is a game-changer for the life sciences sector.”

The Clean Fit service aligns seamlessly with CleanSpace’s mission to support and enhance the growth of the life science industry. It provides a comprehensive look at the company’s cleanroom capabilities while eliminating complexities associated with setting up such sophisticated spaces.

CleanRooms International Selected by Instrumentum for Sterile Processing Cleanrooms

CleanRooms International (CRI) – a leading manufacturer of state-of-the-art cleanroom solutions, is delighted to announce that it has been selected as the trusted partner to design and equip cutting-edge ISO 7 Sterile Processing Cleanrooms for Instrumentum.

Instrumentum is an outsourced provider of sterilisation services for surgical instruments in advance of surgeries, raising the quality of sterilisation and quantity of surgical instruments available for surgery centres and hospitals. The rapidly emerging service allows surgery centres and hospitals to focus their efforts on core competencies and their resources toward better patient care by outsourcing instrument sterilisation to a trusted, specialised service partner. Instrumentum established their new headquarters in The Research Park at Florida Atlantic University in Boca Raton, FL and is an emerging leader in this arena.

The ISO 7 Sterile Processing Cleanroom is a pivotal component of Instrumentum’s mission to uphold the highest standards of sterility, ensuring patient safety and health. CleanRooms International is dedicated to meeting this vital need by providing a custom cleanroom solution tailored to the exacting requirements of Instrumentum’s proprietary sterile processing solutions.

“We are honoured to complete the first project for Instrumentum, and to be chosen as their cleanroom partner for future expansion,” said Tim Werkema, President and CEO of CRI. “Our team is fully committed to delivering a cleanroom that not only meets but exceeds the stringent standards of sterile processing. We recognise the critical role of this cleanroom in ensuring patient safety and will spare no effort to provide a solution that matches the exacting needs of Instrumentum.”

“CleanRooms International is a trusted name in the cleanroom industry. We are proud to partner with CleanRooms International due to their commitment to quality and delivering a state-of-the-art cleanroom solution customised to our specific needs,” said Dan Johnson, CEO of Instrumentum. “The fact that they manufacture the majority of the cleanroom components in their builds was a determining factor during the evaluation process.”

This partnership between CleanRooms International and Instrumentum marks a significant milestone in the journey towards improving the standards for sterilisation services provided to the healthcare industry in the United States. Use of third-party sterilisation service companies has already become a normalised practice in several other countries around the world, and this partnership will now provide those services in the US.

Conducting the sterilisation process in a protected and certified environment that is built by CleanRooms International is empowering Instrumentum to deliver best-in-class medical device sterilisation services to surgery centres and hospitals and raise the bar for accountability in delivering “Sterile Every Time”.

FAULHABER opens modular cleanroom for the production of medical technology products

On September 13, the new cleanroom of the FAULHABER headquarters was unveiled and presented with both management and project managers present at the opening.

The cleanroom has a surface area of ​​90 sqm and will be used in the future to make products for medical technology and the pharmaceutical industry under controlled conditions. Production in the cleanroom will start in the middle of next year.

The medical technology market is continuously shaped by new trends, and the requirements for quality and purity of the applied drives pose specific challenges. To create more production capacity for drive systems for this future industry, FAULHABER recently installed and opened a new cleanroom at its main location. The drives that will be made here from 2024 meet the special requirements of the medical industry and are suitable for all kinds of medical and pharmaceutical technology.

The new cleanroom has a surface area of ​​125 sqm, of which 90 sqm is reserved purely for production, surrounded by airlocks for personnel and equipment to ensure that cleanroom conditions are maintained.

Andreas Melzer is the head of the Safety, Facility & Maintenance department at FAULHABER. He explains: “Our cleanroom is certified according to ISO Class 7. This means that the permitted concentration of particles in the air is limited, as is microbiological contamination of the air.”

This level of cleanliness is achieved by changing the air 25 times per hour, which means that the air is completely replaced approximately every two and a half minutes. By comparison, in other production areas without cleanroom conditions, the air is replaced three or four times per hour. That shows how powerful the ventilation system for the new cleanroom is.

It took the project team seven months to set up the new production space.

The construction work was carried out behind a wall, which protected the ongoing production from penetrating dust. The new cleanroom was opened on 13th September, 2023 in the presence of the project team and Managing Directors Lutz Braun, Dr Udo Haberland and Hubert Renner.

For FAULHABER, the new addition means an increase in production capacity. The branch in Schönaich, Germany, has had a cleanroom tent for products for the semiconductor industry since 2021.

Melzer added: “But the first permanent cleanroom at this location is something very new, and very exciting for us.”

Commissioning is planned for mid-2024, when there will be a permanent team of FAULHABER employees trained and equipped for cleanroom work, who will primarily work in the new facility.

Before then, the room still needs to be equipped with workstations and equipment, and the cleaning system still needs to be connected to the material lock. This ensures that all components used meet cleanroom requirements.

Thanks to the modular structure of the new FAULHABER cleanroom, future expansion of production capacity in this area is possible.

SMC expands manufacturing capabilities with new cleanroom

SMC has expanded its manufacturing capabilities with the completion of a new cleanroom in Noblesville, Indiana.

The cleanroom footprint is approximately 25,000 sqft, or half a football field, and is designed with a modular aluminum honeycomb wall system which allows for layout versatility and future expansion or modifications to the cleanroom.

The modular construction also facilitates the progression of cleanliness as an operator will put on a cleanroom suit, covered from head to toe, in an ISO 7 room, and move through air locks to progressively arrive at the ISO 5 cleanroom work areas.

“After successful construction of our cleanroom, operating and maintaining the working conditions within it will be where SMC must apply extra care. An ISO 5 cleanroom must always meet minimum standards across the five fundamental parameters to be defined a proper facility for human comfort. These five are: temperature, humidity, airflow, filtration, and pressure.

For example, the recommended temperature for ISO 5 is 68°F (+/- 2°) for operator comfort when wearing a cleanroom suit and PPE. Relative humidity must be set at a level higher than 30% and lower than 50%; an RH below 30% will create static electrostatic discharge which can damage components or attract particulate matter, and above 50% will promote biological contaminates such as mold or bacteria growth,” said Chad Bosler, VP of Operations.

“Our ISO 5 cleanroom will be manufacturing and assembling high purity components essential to semiconductor chip manufacturing as well as food grade products for the food and beverage industries.

All our clean components are assembled and packaged in a work environment where HEPA filtration covers 70% of the ceiling areas with a downward airflow that circulates and changes the inside air 360 times per hour while maintaining an outward positive air pressure compare to the adjacent room,” said Senior Engineer, Garrett Flora.

SMC’s cleanroom construction is only one of many future capital investment projects on its corporate campus in its expansion pipeline. Over the next ten years, its plan is to increase current employment of 850 workers by 35% to about 1,157 employees and invest a total of $30.2 million in industrial facilities at its headquarters by 2032.

IPA Clean Swab

IPA Clean Swab is a high quality, cleanroom swab for the critical cleaning of small and hard-to-reach areas. The wide paddle head offers extraordinary cleaning abilities by featuring an inner layer of foam for absorbency and an outer layer of micro-denier for holding contaminants and avoiding cross-contamination.

A four-inch handle containing a reservoir of 99.7% isopropyl alcohol adds even more cleaning power to the paddle head. Once the solvent is released from the handle, it is absorbed into the soft paddle head. Unlike some self-saturating swabs, the IPA Clean Swab is wrapped in microfiber for ultimate cleanliness. This easy-to-use system is ideal for removing lubricants, adhesives, residues, or other contaminants on circuit boards, sensors, or stencils. It is perfect for cleaning laboratory testers, electronic components, keyboards, print heads, and printers.

Class 100 laundered and packaged, IPA Clean Swab is free of particulates making it suitable for medical surfaces. With no tribogeneration, the swab is safe to use on ESD static-sensitive devices when the head is moist.

IPA Clean Swab is effective for medical device manufacturing and assembly, electronics manufacturing and assembly, IoT, and telecom applications.

  • ISO Class 4-7 (class 10 – 10,000) compatible
  • Ultra-low particle fiber, NVR, and Ion levels
  • High solvent capacity
  • Micro-denier polyester over foam
  • Non-abrasive wide paddle head
  • 99.7% IPA-filled 3.5″ polypropylene handle
  • Free of silicone, amides, DOP contamination
  • Safe for ESD static-sensitive surfaces
  • Ultrasonic welding with no adhesives