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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Processes and Sterilizes Liquid Parenteral Pharmaceuticals

The SVP Essential and LVP systems from Syntegon provide modular solutions tailored for liquid pharmaceutical manufacturing. Designed for flexibility, these systems handle mixing, homogenizing, and filling of both small and large volume parenterals. With capacities ranging from 13 to 20,000 liters, they integrate seamlessly into production lines through automation, enabling efficient batch and continuous operations. These systems feature robust CIP/SIP capabilities, ensuring rapid, contamination-free cleaning. Constructed with stainless steel, they comply with GMP and FDA standards, making them ideal for antibiotics, infusion solutions, and cell culture media production. The prefabricated cleanroom design reduces installation time and guarantees a minimal footprint, adapting to various production requirements. With over 70 pre-tested modules and ISA-88 structured automation, Syntegon’s solutions ensure process precision and operational control.

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Fills and Seals Vials for Liquid Pharmaceuticals

The FLC 3000 from Syntegon is designed to efficiently fill and seal vials in liquid pharmaceutical production lines, particularly for high-demand products like Covid-19 vaccines and monoclonal antibodies. Its compact GMP-compliant design supports a wide filling range of 0.2 to 500 milliliters and achieves throughput of up to 600 vials per minute, reducing changeover times with only three format part sets required. The machine’s peristaltic pump technology ensures precise dosing while maintaining sterility, and it integrates seamlessly into production environments with options for full in-process control. A clean and hygienic design facilitates easy maintenance and operator safety, meeting stringent GMP and FDA requirements. The FLC 3000 can be customized with additional filling technologies and systems as needed, providing robust support for both batch and continuous operations.

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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 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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Performs Precise Freeze-Drying for Biotherapeutics

The Freeze-drying equipment from Telstar integrates a cryogenic refrigeration system tailored for pharmaceutical and biotechnology applications. It offers precise freeze-drying capabilities essential for stabilizing biotherapeutics, probiotics, and high-potency drugs. Equipped with dual cryogenic freeze-dryers, it features a shelf area of up to 29.7 m² and an ice condenser capacity reaching 600 kg. Using a multi-stage high vacuum system, it achieves shelf temperatures down to -70°C and condenser temperatures of -100°C, thereby ensuring effective moisture removal and product stability. Semi-automatic loading and unloading carts, coupled with Lyosuite SCADA control, facilitate seamless operation and integration into production lines. Compliance with GMP guidelines and a CIP/SIP system enhance cleaning efficiency, while its N2 chamber environment supports anaerobic loading. This system is ideal for manufacturers demanding precision in lyophilization processes to produce products like live attenuated vaccines and novel therapeutic compounds.

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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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Preserves and Stores Biological and Medical Samples

The Telstar Boreas U830 Upright Ultra Low Temperature Freezer offers optimal storage solutions for biotech and medical environments by leveraging ultra-vacuum insulation technology. This design significantly enhances insulation capacity, supporting long-term preservation of critical biological samples such as DNA, cells, and virus cultures. With a storage capacity increased by 30% within the same footprint, it suits various applications from pharmaceuticals to deep-sea food storage. Its AISI 304 stainless steel interior and use of natural refrigerants ensure longevity and environmental compliance. The freezer’s user-friendly control panel and heated pressure relief port facilitate seamless operation and easy access, making it a crucial component for laboratory efficiency and sample integrity.

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