Filling and Closing Machine for Small Batches

ROTA xfillR aseptic filling system is the perfect fit for processing the smallest batches in research and development as well as in the production of batches for clinical trials in the pharmaceutical and biotech industry. Filling different containers with just one extremely compact machine means not only time and cost savings, but also an investment in flexibility and thus lasting independence.

xfillR is also the ideal system for processing small batches in the biotech industry.

Advantages

Processing of a wide variety of objects

The xfillR is the innovative development of a multipurpose machine for processing different objects such as vials, syringes, eye droppers, nasal sprays, cartridges, micro-tubes or Sarstedt® tubes, in nests, trays and in bulk.

To close the objects, the xfillR can handle various types of closures, such as stoppers, droppers, aluminum caps, screw caps, spray pumps, RayDyLyo®, etc.

To close these objects, xfillR also handles a wide variety of closures, such as stoppers, plungers, droppers, aluminum caps, screw caps, snap-on closures, RayDyLyo® etc.

 

Gentle transport

The xfillR and its precise individual handling of each object guarantees gentle transport without glass/glass or glass/metal contact. Scratches and particle emissions are thus avoided.

Everything with one compact machine

With the xfillR it is possible to process all cylindrical objects, whether RTU (Ready To Use) in nests or trays, whether free standing or not, in complete batches or just a single object. Filling is accomplished by means of a rotary piston pump or a peristaltic pump. The 100% check of the filling is done with a weighing cell. Finally, plugs, piston plugs or droppers can be inserted and caps placed, crimped, screwed or snapped on.

Properties

+ Unique and multipurpose machine

+ High flexibility – “all in one” solution

+ Small batch sizes from 1 to 10,000

+ Modular design, expandable at any time

+ Processing of a wide variety of objects

+ Versatile closures can be processed

+ High versatility of closures

+ Very compact design, also available as a wall installation

+ Short changeover time

+ Easy to operate

+ High degree of automation due to full servo-drive system

+ Suitable for RABS & Isolator – from aseptic to high potent application

Popular options

+ Debagging station for nested objects

+ Debagging station with inverting device for vials in trays.

+ 100% or statistical weigh-check verification & control

+ “Zero-Reject“ – system

+ Peristaltic pump filling

+ Recirculation system for suspensions

+ RTP alpha port

+ cRABS or Isolator

+ Particle monitoring

+ Qualification documents

+ Electronic batch protocol

+ 21CFR Part 11 compliance

+ Batch record printer

+ Filling by peristaltic pump

Model Versions

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Thanks to simple changeover of size parts and user-friendly recipe management, ROTA washing machines highlight the shortest hangeover times assuring highest productivity for our customers.

Up to 24.000 per hour

Efficient and gentle washing

In parenteral packaging, open containers have to be washed before they can be sterilised. Already at this first stage, quality in washer design and construction pays off. Issues in the washing process will downstream process steps. ROTA washing machines are suited best for an efficient and gentle washing of ampoules and vials.

Combined use of ampoules and vials can be easily achieved with one and the same Rota washing machine. Simply exchange ampoule pincers and ampoule format parts with the ones for vials within a few minutes. This saves investments for buildings, machines, personnel and equipment.

High-security standard

The transportation of the containers by means of precision pincers and the latest servomotor technique guarantees a high-security standard with respect to glass breakage and cross-contamination.

From 9 mm to 68 mm container diameter

Thanks to simple changeover of size parts and user-friendly recipe management, ROTA washing machines highlight shortest hangeover times assuring highest productivity for our customers.

Up to 24.000 per hour

A comprehensive variety of models guarantees an optimal adaption to the capacity range as needed.

So you know what‘s inside

Labels are the signboard of all products. Drugs may be marketed only with properly attached and error-free labels. A particular requirement to labelling therefore is the outstanding focus on product safety and quality. There the labelling machine becomes part of the quality control system.

Focus on safety

ROTA labelling machines for self-adhesive labels meet all requirements of the pharmaceutical industry in an optimal manner. And this with top precision at high speeds. Compact design, precise label handling and state of the art on-board electronic controls are the guarantee for your investment.

Up to 24.000 per hour

A variety of machine models assures an optimal match to the requirements of your production performance. Upright transport of all containers, whether of glass or plastic, guarantees a high precision application of labels. Flexible solutions at in-feed and out-feed of the labeller allow its integration into packaging lines from other manufacturers, as well.

Like a tailor-made suit

ROTA labelling machines are ideal for integration of any kind of control and printing features from various manufacturers. You as customer inform us of your requirements and preferences; we deliver the fully integrated solution as well in hardware as in software.

For more information Contact Us 

Highest flexibility for the best conditions

Based on its well-proven ampoule filling and sealing machines, ROTA was one of the first machine manufacturer proposing in its port-folio so-called combination machines. These present the capability to fill and close ampoules but also fill and stopper vials as well, with minimum changeover. We continue to offer this flexibility nowadays with the most modern machines.

Up to 24.000 per hour

From small scale batches to mass production, ROTA has with its know-how and the performance range of its machines the right answer for your application when it comes to process ampoules and vials on the same machine.

From Ø 9 mm to Ø 52 mm

Your manufacturing also benefits from the high flexibility and the ease of use of our machines. Combination machines feature quick changeover without dismantling main processing parts, increasing machine availability and productivity.

Process concepts for minimal operating personnel intervention | Integrated lines for vials

The manufacturing of large quantities requires highly automated process concepts. To achieve this goal, machines for the basic processing steps like washing, sterilizing, filling and closing are integrated in a production line. The large throughput capacities allow for low manufacturing costs. The reduced operator impact on the objects leads to even improved process quality of the sterile filling.

With engineers and technicians at your hand …

All automated ROTA machines can be linked and integrated into compact processing lines. Even ampoules, vials, and bottles can be easily processed on the same system. Large and complex machinery of this type is commonly designed and built to specific customer needs. Already in the design phase, an experienced team of engineers and technicians is supporting our customers.

Starting from 1.500 vials per hour

The application field is almost unlimited. Be it standard products, serums, antibiotics, or freeze-dried products – there is a suitable ROTA line available. Furthermore, oRABS, cRABS or isolator technology can of course be implemented.

Up to Ø 68 mm

Our systems are characterized by their compactness and low utility consumption. Your manufacturing also benefits from the high flexibility and the ease of use of our machines. Particularly of interest are our flagship combination lines where ampoules, vials, and bottles are processed on the same system.

For more information Contact Us 

One system supplier for integrated lines with Freeze Dryers

In addition to its capability in offering complete processing lines for ampoules and vials, ROTA Verpackungstechnik entered in an extended partnership with Austar to complete its port-folio with freeze drying capability, including automatic loading and unloading systems and barrier systems as well.

Core equipment for the production of lyophilized products

Austar freeze-dryer designed in Germany, is widely used in pharmaceutical fields including, Antibodies, Therapeutic Proteins and Peptides, Vaccines, Chemical preparations and High Potent compounds, Plasma Blood preparations, and APIs, involving different scale applications such as laboratory, pilot-scale production and commercial production etc. The production capacity ranges from 0.5m2 to 40m2. We can provide customized solutions for toxic products, organic solvent products and liquid nitrogen refrigeration according to clients’ special needs.

The Freeze Dryer automatic loading & unloading system can be equipped with oRABS, cRABS and isolator according to different product requirements. Together with the filling line forms a highly integrated sterile filling and sealing system for lyophilized powder, leading into a versatile range of applications in terms of product, container size and production capacity.

Process development support services: Freeze Drying Laboratory

Equipped with cutting-edge technologies, the Austar Freeze Drying Laboratory is capable of providing comprehensive services for determination of Process critical parameters with development of freeze-drying cycle, cycle optimization and scale-up, analysis of the quality of freeze-dried product, troubleshooting and training.

The AUSTAR Freeze Drying Laboratory has the technical consulting team with extensive industry experience in freeze-drying cycle development, cycle optimization, scale-up and technology transfer, and is able to provide services to meet the requirements of development of freeze-drying cycle and freeze-dried product. By using analytical equipment such as Differential Scanning Calorimetry (DSC), Freeze Drying Microscope (FDM) and Karl-Fischer coulometer, physicochemical characteristics of the product prior to and after freeze drying could be determined, which could allow us to gain deeper understanding about the product and the process, and thereby optimizing the freeze-drying cycle, increasing the production efficiency and improving the product quality.

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Ampoule filling and sealing machine from small scale batches to mass production

Virtually zero breakage

Ampoules – the perfect container to store parenteral fluids. It is self-evident that the filling and sealing may only take place under optimal sterile conditions. In order to achieve the high level of safety and process reliability, the appropriate technical solution and decades of experience are required.

Highest flexibility for the best conditions

A comprehensive list of optional features and accessories allows our machines to meet your individual needs. Combination machines in which ampoules, vials and bottles can be filled and closed with minimal changeover work underline our flexible and wide machine port-folio.

Up to 24.000 per hour

With its ampoule filling and sealing machines ROTA is a leading manufacturer in this field. From small scale batches to mass production, ROTA has with its know-how and the performance range of its machines the right answer for your application.

For ampoules from 0.2 ml to 30 ml 

Ease of handling unburdens cleaning and sterilisation of the filling system, whether manually or with automatic CIP/SIP systems.

For more information Contact Us 

Process concepts for minimal operating personnel intervention

The manufacturing of large quantities requires highly automated process concepts. To achieve this goal, machines for the basic processing steps like washing, sterilising, filling and closing are integrated in a production line. The large throughput capacities allow for low manufacturing costs. The reduced operator impact on the objects leads to even improved process quality of the sterile filling.

With engineers and technicians at your hand

All automated ROTA machines can be linked and integrated into compact processing lines. Even ampoules, vials and bottles can be easily processed on the same system. Large and complex machinery of this type is commonly designed and built to specific customer needs. Already in the design phase an experienced team of engineers and technicians is supporting our customers.

Starting from 3.000 ampoules or vials per hour

The application field is almost unlimited. Be it standard products, serums, antibiotics or freeze-dried products – there is a suitable ROTA line available. Furthermore oRABS, cRABS or isolator technology can of course be implemented.

From Ø 9 mm to Ø 52 mm

Our systems are characterised by their compactness and low utility consumption. Your manufacturing also benefits from the high flexibility and the ease of use of our machines. Particularly of interest are our flagship combination lines where ampoules, vials and bottles are processed on the same system. This saves investments for buildings, machines, personnel and equipment