Robotic Aseptic Fill-Finish: ABB Cleanroom Arms

At the end of making any injectable drug, a sterile liquid goes into a sterile vial, syringe or cartridge, and the container is closed before a single microbe gets in. That last step is called fill-finish, and robotic aseptic fill-finish is slowly replacing the people who used to do it. This post follows the job from wartime laboratories, where people measured penicillin into ampoules by hand, through cleanrooms and sealed isolators, to the robotic lines being shown this autumn. It ends with where ABB's cleanroom robots and cobots fit today, and what is still hard about putting robots next to open vials, from hydrogen peroxide cleaning to the cost of a line.

Capped vaccine vials on a production line at Shifa Pharmed near Tehran, 2021. Photo: Hamed Jafarnejad / Wikimedia Commons (CC BY 4.0)

How sterile filling moved from open benches to sealed boxes

During the Second World War, penicillin production in Britain was a laboratory job scaled up. A 1943 Ministry of Information photo shows a laboratory worker measuring purified penicillin into ampoules or bottles by hand. The filled containers were then freeze-dried under vacuum until only the penicillin powder was left, ready to be dissolved again before an injection. The work was done at open benches by people in gowns, and the person doing the filling was also the biggest contamination risk in the room, since people shed skin and particles all day.

A laboratory worker measures purified penicillin into containers in England, 1943. Photo: Richard Stone, Ministry of Information via Wikimedia Commons (public domain)

Machines arrived early for the filling itself. A 1932 photo from the glassmaker Schott shows an automatic device for filling medicines into ampoules. The room around the machine changed more slowly. In the early 1960s the physicist Willis Whitfield at Sandia National Laboratories designed the modern cleanroom, with a constant stream of highly filtered air flushing particles out of the space. People stayed at the line for decades. A 1975 photo from Oy Medica's plant in Helsinki shows three employees in caps and masks filling ampoules by hand.

Three employees filling ampoules by hand at Oy Medica's plant in Helsinki, 1975. Photo: Eeva Rista, Finnish Heritage Agency / Wikimedia Commons (CC BY-SA 4.0)

The next step was to take the operator out of the critical zone altogether. Isolators are sealed boxes with glove ports, decontaminated with vaporized hydrogen peroxide before each run, so the filling area stays Grade A while the room around it can be a lower grade. Robots moved into those boxes next. The Canadian company Vanrx Pharmasystems, founded in 2007, built the SA25 Aseptic Filling Workcell, where a robot does all the filling inside a closed isolator with no glove ports at all. Cytiva bought Vanrx in February 2021 to add drug product filling to its bioprocessing range.

A sealed glovebox at Gdansk University of Technology, the same glove port idea used on pharmaceutical isolators. Photo: LukaszKatlewa / Wikimedia Commons (CC BY 4.0)

Annex 1, AI vision and ABB robots on today's fill lines

Regulation is pushing in the same direction. The revised EU GMP Annex 1 for sterile medicines was published in August 2022 and took effect on 25 August 2023. It asks every site for a contamination control strategy and says technologies such as restricted access barrier systems, isolators and robotic systems should be considered to protect the product. Isolators and RABS are not strictly mandatory, but a new plant that skips them has to explain why.

Gowned operators at work in the cleanroom of a vaccine plant in Iran, 2021. Photo: Tehran Times / Wikimedia Commons (CC BY 4.0)

On 15 September Cleanroom Technology reported that Steriline will show its VKSFCM11 robotic filling line under an isolator at CPHI Milan from 6 to 8 October. The line uses an AI camera system called OmniAI Vision, with cameras placed away from the filling and capping area so they do not block the first air, and it is aimed at small batches and cell and gene therapies. On 28 September Genentech broke ground on a $750 million expansion in Hillsboro, Oregon, adding device fill-finish and roughly 250 jobs that mix manufacturing with AI, automation and robotics skills.

Workers place filled vials into trays by hand at the end of a vaccine line, 2021. Photo: Sadegh Nikgostar / Wikimedia Commons (CC BY 4.0)

ABB is not the usual name inside a filling isolator, and we found no ABB fill-finish project to report. Its cleanroom robots are certified to ISO 14644-1, and ABB lists pharmaceuticals and biotech among their markets. The IRB 1200's particle emission meets ISO class 3, and the IRB 1300 comes in a Clean Room version. Around the isolator, arms like these could load nested tubs, move trays to freeze dryers or pack finished vials, while an IRB 360 FlexPicker could handle high speed packing downstream. We covered similar work in cell therapy manufacturing.

An ABB IRB 1300 Clean Room robot. Photo: ABB

What aseptic filling robots still have to solve

The direction for factories is fewer people in Grade A and more robots that never leave it. Small batch medicines, such as personalized cell therapies, need lines that change product quickly and fill a few hundred units instead of millions. Robots suit that, because a new container format can often mean a new program and gripper rather than a new machine. The open problems are validation and cleaning: every robot surface must survive repeated hydrogen peroxide cycles without shedding particles, and every motion must be proven not to pass over an open vial.

An ABB GoFa cobot working with lab instruments at the SLAS lab automation conference. Photo: ABB

Cost and skills are the other limits. A robotic isolator line is a large investment, and the people who run it need to understand robots, airflow and sterile practice at the same time. Simulation helps here: a filling cell can be laid out, its reach checked and its paths tested in RobotStudio long before anyone builds the isolator around it. Collaborative arms are already common in drug research labs; XtalPi, for example, built automated lab workstations with ABB GoFa CRB 15000 cobots.

Automated lab workstations at XtalPi, built with ABB GoFa cobots. Photo: ABB

Patients never see an aseptic filling line, but they handle what it makes. Genentech's Oregon site will add device fill-finish, including combination products, and devices such as prefilled syringes and autoinjectors let patients treat themselves at home without drawing a dose from a vial. More of those devices will be filled and assembled by robots inside sealed boxes. The open question for the next few years is whether smaller drug makers can afford robotic lines, or whether that work goes to the few contract manufacturers that can.

An autoinjector, one of the drug delivery devices filled on device fill-finish lines. Photo: Raimond Spekking / Wikimedia Commons (CC BY-SA 4.0)

Innovation

AI solutions for effortless ABB robot control.

Automation

Robotics

ceojohntran@chatwithrobot.net

+84905311611

© 2025. All rights reserved.

qtran1215@gmail.com