Inspect ampoules and vials with highly reliable semi-automatic machines

Rota offers inspection of parenteral liquid drug through semi and fully automated inspection machines with state of the art camera systems.  The semi-automatic machines are cost-effective, reproducible and can be systematically validated.

The integrated cameras capture images of the objects to be inspected and send these magnified up to 10 times on the LCD screen. Because nothing checks more reliably than a human being, up to six objects are presented to the operator at simultaneously, who can then decide quickly whether the liquid is free of particles or not. The machines can reach a speed of up to 6.000 per hour for the ampoules.

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Customisable Ampoule filling machine with the highest filling accuracy

Rota’s filling machines allow the filling from small scale batches to mass production with optimal performance range. Filling can be done for the ampoules and vials that are from 0.2 ml to 30 ml and can afford up to 24.000 per hour.

Ampoules are the perfect containers to store parenteral fluids and their filling demands rigidly controlled sterile conditions. Rota’s own rotary pumps guarantee high filling accuracy in continuous operation without re-adjustment. This Ampoule filling machine comes with an easy to handle approach when looking to clean and sterilise the filling system, whether manually or with automatic CIP/SIP systems.

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Simulates Subcutaneous Injections for Formulation Testing

The SCISSOR N3 from Pion is an in vitro subcutaneous injection simulator designed for biopharmaceutical and pharmaceutical R&D. This tool accurately mimics the physiological conditions experienced by injectables, allowing you to assess drug release dynamics and optimize formulations without relying on animal models. Ideal for screening excipients and rank ordering formulations, it yields bio-relevant insights for injectable drugs, including adalimumab and insulin formulations. Compatible with optional fraction collectors and the Rainbow R6 UV-vis spectrometer, the SCISSOR N3 enables real-time, in situ data collection. It supports liquid formulations in controlled, bench-top environments, providing critical data for long-acting injectables and innovative drug delivery solutions.

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Processes and Encapsulates Liquids at High Pressure

The DeBEE 2000 from Pion is a high-pressure homogenizer designed for diverse applications within the pharmaceutical, biotech, chemical, food, and cannabis industries. It uniquely combines R&D versatility with pilot scale production capabilities, enabling effective processes such as cell disruption, particle size reduction, and nano-encapsulation. This system is ideal for creating protein therapeutics, liposomal encapsulated vitamins, and other intricate formulations, including cannabis-infused beverages. Capable of handling both liquids and slurries, the DeBEE 2000 ensures product consistency and quality with cGMP compliance and SCADA integration for real-time monitoring and control. It features a clean-in-place (CIP) system, simplifying maintenance while ensuring hygiene standards are maintained. With electronic signature compatibility and comprehensive data collection functionalities, this equipment supports stringent regulatory requirements. Pion provides customization options to meet specific production needs, backed by engineering support for seamless integration into your existing production line.

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Processes Nanoemulsions and Reduces Particle Size

The Micro DeBEE Laboratory High-Pressure Homogenizer from Pion is a versatile bench-top solution tailored for precise laboratory operations. This air-powered unit excels in processes such as cell lysis, nanoemulsions, particle size reduction, and dispersion, achieving industry-leading results with operating pressures up to 30,000 PSI. Designed for pharmaceuticals, biotech, and cosmetics, it aids in producing high-yield formulations like liposomal vaccines, protein therapeutics, and polymeric nanoparticles. With a flow rate of 15 LPH and requiring only clean, dry air for operation, it integrates seamlessly into your lab, offering no-assembly-required maintenance. Engineered for bioavailability enhancement and tighter particle distribution, it complies with laboratory standards while its small footprint and easy cleaning optimize workflow efficiency.

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Labels and Verifies Pharmaceutical Containers

The LR105 by CAM is a high-speed labelling solution specifically designed for the pharmaceutical industry. This automated machine excels in labelling vials, ampoules, carpules, and syringes at speeds of up to 500 labels per minute. Capable of both inkjet and thermal transfer printing, the LR105 integrates seamlessly into your production line, offering full control via an intuitive operator panel. Customizable options include checking systems for accurate printing verification, label code readers, and product rejection capabilities for quality assurance. Ideal for pharmaceutical manufacturers, the LR105 ensures compliance with stringent industry standards and provides reliable, precise labelling for a wide range of liquid pharmaceutical products, from insulin vials to chemotherapy drug ampoules.

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Performs Sterilization of Diverse Pharmaceutical Products

The SteriMega Plus from Telstar is a saturated steam sterilizer designed to handle a wide range of materials, including solid, porous, and liquid products, critical in pharmaceutical and biotech manufacturing. Its high-performance steam sterilization process conforms with GMP standards and European certifications like EN 285 and PED, ensuring regulatory compliance. With customizable options, this equipment offers versatility to address specific production needs, making it suitable for sterilizing ampoules, syringes, culture media, and more.

Incorporating advanced automation, the SteriMega Plus seamlessly integrates into existing production lines, offering PLC control for efficient operation. Its robust design supports batch, pilot, and continuous operations. Material options like stainless steel enhance durability and corrosion resistance. Equipped with a CIP (Clean-In-Place) system, it simplifies maintenance and ensures minimal downtime, solidifying its role as a reliable asset in ensuring sterility and product safety in critical production environments.

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Fills Lyophilized Pharmaceuticals with Precision

The Sterile Lyophilised Filling Line from Telstar is designed specifically for pharmaceutical and biotech manufacturers, ensuring sterile and precise filling of lyophilized pharmaceuticals such as monoclonal antibodies and injectable drugs. This engineered-to-order system features a multi-chamber design that facilitates seamless integration into existing production lines, addressing stringent regulatory requirements with GMP compliance. The line’s high-accuracy weighing and filling capabilities ensure consistent dosing, minimizing product wastage and contamination risks. With automated PLC controls, it allows for remote monitoring and integration with upstream and downstream processes. Constructed from high-grade stainless steel, it offers excellent corrosion resistance and is equipped with a CIP system for efficient cleaning, reducing downtime and ensuring continuity in production. Customizable elements, such as chamber sizes and throughput rates, ensure that the system can be tailored to your specific production needs, accommodating various pharmaceutical powders, lyophilized vaccines, and controlled-release formulations.

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Ensures Sterility in Pharmaceutical Testing

The Pura 2+ Sterility Test Isolators from Telstar are engineered for pharmaceutical and biotechnology sectors, offering a double-chamber system for continuous sterility testing. The isolators maintain Class ISO 5 (Grade A) air cleanliness, vital for injectable vials and lyophilized pharmaceuticals. These units facilitate controlled sterility testing through a positive-pressure environment and integrated HP+® bio-decontamination, ensuring process integrity. Designed for flexible operations, they allow additional materials to be bio-decontaminated in a transfer chamber while ongoing tests continue in the main chamber. The Pura 2+ prioritizes contamination-free environments with H2O2 monitoring and rigorous glove testing. Fully compliant with GMP standards, it is an ideal choice for manufacturers seeking reliable sterility assurance in batch and continuous production settings.

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Monitors Sublimation Front Advancement in Real-Time

The Telstar Sublime is a real-time sublimation front monitoring system designed for pharmaceutical and biotechnology industries. This innovative system employs single-use wireless probes to track the sublimation front temperature interface during freeze-drying. It excels in optimizing cycle development by providing accurate multipoint temperature readings, thus enhancing process understanding and repeatability. Key applications include the production of monoclonal antibodies, lyophilized vaccines, and vitamin tablets. The Sublime integrates seamlessly with automatic loading and unloading systems, reducing logistics complexity and cross-contamination risks. It is fully compliant with cGMP and FDA 21 CFR Part 11 standards, ensuring the highest level of quality control for your operations.

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