Steriline, a company producing complete aseptic packaging lines for injectable and ophthalmic products for global pharmaceutical companies, will be participating in CPHI Frankfurt.
Steriline
At the Steriline stand (Hall 9.0, Stand 9.0F6), visitors will be able to view the features of the new RNFM22 robotic filling line, an ideal solution for all pharmaceutical companies looking to enhance manufacturing efficiency while ensuring compliance with the industry’s strict standards - an achievable target thanks to the line’s flexibility and advanced automation integrated with AI applications.
Specifically, the line that will be presented at the trade fair is intended for Beximco Pharmaceuticals Ltd. (Beximco Pharma), an emerging generic drug player committed to providing access to affordable medicines. Company’s state-of-the-art manufacturing facilities have been accredited by the regulatory authorities of USA, Australia, European Union, Canada, and Brazil, among others, and it currently focuses on building presence in many emerging and developed markets around the world.
Beximco Pharma is consistently building upon its portfolio and currently producing more than 500 products encompassing broad therapeutic categories and the Company has created strong differentiation by offering a range of high-tech, specialized products which are difficult to imitate.
“CPHI is a key event for Steriline to meet with our partners from all over the world,” says Federico Fumagalli, chief sales officer of Steriline. “We are a company that constantly innovates and works on complex and bespoke technologies. The Frankfurt event is therefore an important showcase for presenting all our solutions to the market.”
The RNFM22 is an advanced robotic solution designed for primary packaging, ideal not only for pharmaceutical companies but also for all CDMOs, i.e. companies that offer drug manufacturing services to pharmaceutical companies. The machine manages nested bottles (from 6R to 50R) and can be configured to also prepare pre-filled syringes (PFS) and cartridges. Equipped with a Combo dosing system (peristaltic pumps or volumetric pumps, depending on product type) and an IPC system for weight control (statistical or 100%, according to customer requirements), the RNFM22 employs three Stäubli robots for handling primary containers with zero glass-to-glass contact. The machine also has a stopper vibrating feeder with a tool-less format change system and a system for stopper position inspection system at the outfeed. Although this inspection component is not present in the solution on display, it can be easily integrated.
The line on the CPHI stand consists of an Automatic Debagger (ADB), which removes the tub from the external protective bag, an Automatic Delidder / Deliner (ADE), which removes two Tyvek sheets (specifically, the upper thermally sealed lid and the internal liner resting on top of the nest) and a two-step robotic filling machine, RNFM22, which processes the “nested” containers directly, ensuring no glass-to-glass contact.
“This approach differs from traditional lines and requires specific, advanced technology,” says Zaim Gashi, sales area manager for South-East Asia and the Balkans of Steriline. “The presence of robots and cameras at every stage of the filling, stoppering and capping process also ensures maximum operational flexibility.”
The syringes and cartridges closing , and total or partial vials stoppering, along with the capacity of the machine to handle both water-like products and suspensions in response to specific customer requests, are the other main features of the RNFM22, which has a production capacity per hour (without IPC) of up to 2,400 vials and 3,500 syringes (1 ml PFS).
The complete line consists of other parts not on display at the trade fair. The first of these is the Automatic Denester (ADN), which neatly removes the bottles from the nest, preparing them for the next processing stages. This is followed by the Positive Diverting System (PDS), which can direct the vials to the freeze dryer (lyophilised products) or to the capping machine (liquid products). The PDS is equipped with a vision system featuring a dedicated camera for stoppering quality control, which is particularly important for vials intended for the lyophilisation process.
“Lastly, there is the VCM50 capping machine, also designed according to the latest requirements set out in Annex 1,” continues Zaim Gashi. “Before capping, a vision system with cameras verifies the stopper position, even in the event of return from the freeze dryer. At the end of the cycle, another vision system inspects capping quality, ensuring a result that conforms to the customer’s requirements.”