Aseptic Processing

Depyrogenation tunnels use high-temperature air (typically 250°C and over) to sterilise and remove endotoxins from glass containers. These systems are essential in aseptic manufacturing for preparing bulk vials and ampoules before filling. They operate continuously, ensuring uniform heat distribution, validated lethality and compliance with pharmacopoeia and GMP Annex 1 standards.

Barrier technologies, including isolators and RABS, ensure Grade A protection by physically separating operators from the aseptic zone, reducing contamination risks. Designed for full compliance with GMP Annex 1 and first air requirements, they can be integrated with fully automated fill-finish systems. These barriers can also be configured to handle high-potent or biohazardous products, ensuring both product and operator safety in critical processing environments. 

Decontamination systems use VHP (Vapourised Hydrogen Peroxide) to decontaminate tubs and trays containing RTU components before entry into aseptic areas. These systems avoid risking the contamination of aseptic areas, eliminating complex debagging operations, and are often used as part of a fully automated fill-finish line for RTU components. The process guarantees bioburden reduction while meeting the latest regulatory standards for aseptic manufacturing for Grade A material transfer. 

RTU debagging and opening systems aseptically introduce RTU tubs and trays into Grade A environments, ensuring compliance with No-Touch Transfer (NTT) principles. Available in both fully automated robotic versions and semi-automatic configurations with operator assistance, these systems integrate seamlessly with isolators or RABS. They feature custom-designed mouse-holes to ensure proper class separation and full conformity with GMP Annex 1 requirements.

Robotic denesting systems automate the transfer of RTU syringes, cartridges or vials from their nests into aseptic filling lines. These units ensure precise handling, no glass-to-glass contact and compatibility with various primary container formats. They can include vision systems for quality verification and are integrated seamlessly into isolators or RABS environments. 

These solutions are designed for the aseptic filling and stoppering of RTU vials, syringes or pre-capped cartridges, using advanced anthropomorphic robots to ensure precise handling in Grade A environments. Suitable for both small and large batch sizes, they are fully compatible with isolator or RABS integration. Configurations can include 100% In-Process Control (IPC) and scalable layouts, making them ideal for both clinical manufacturing and commercial production. 

Liquid filling and stoppering machines are the core products of IMA Life and are designed for aseptic environments. Fully compliant with GMP Annex 1 and FDA requirements, they introduce sterile solutions into vials and insert rubber stoppers and/or other kinds of closures (i.e. eye droppers, inhalators, etc.) immediately afterwards.
They feature high-speed capabilities, advanced dosing solutions (peristaltic, rotary piston, etc.), movable and synchronised nozzle arms, and precise stopper placement to preserve sterility. These systems are often used in medium and large-scale production with In-Process Control strategies.

Cleaning-In-Place (CIP) and Sterilisation-In-Place (SIP) systems are automated technologies used to clean and sterilise pipings and processing equipment connected to aseptic fillers without disassembly. These systems reduce changeover time, minimise manual handling and ensure validated sterilisation cycles. They can be utilised to support any kind of aseptic dispensing solution for injectables and ophthalmic drug products. 

Powder filling and stoppering systems dose sterile powders into vials with high precision and minimal dust generation, ensuring safe and efficient processing. Operating within closed RABS or isolator environments, these systems support various dosing technologies, including vacuum-assisted and auger-based solutions, to accommodate different powder characteristics. Ideal for handling antibiotics, biologics or cytotoxic drugs in compliance with GMP Annex 1.

Automated loading and unloading systems for freeze dryers ensure aseptic transfer of filled containers to and from the lyophilisation chamber. They are integrated in isolators and RABS to assure Grade A continuity to reduce contamination risks and operator intervention. Modular configurations support different types of loading strategies, size formats, and synchronised operation with freeze-drying cycles.

Capping machines can provide precise and secure closure of vials and bottles. These systems apply caps in aseptic areas or Grade A Air Supply (GAAS) areas, often integrated with torque and visual inspection capabilities. Compatible with a wide range of cap types and designed to be managed using steam-sterilisable components and to prevent particle generation, they comply with GMP Annex 1 and FDA guidelines 

Ampoule filling and sealing machines process liquid pharmaceuticals introducing them into open ampoules under laminar airflow and sealing the ampoules using flame technology. These systems offer high throughput, precise dosing and sterile conditions, making them ideal for injectable drugs. Modern configurations support nitrogen flushing, CIP SIP and isolator integrations.

Bag filling and closing systems enable the aseptic filling of small and large volume parenteral drugs into flexible bags under Grade A conditions. Designed for full GMP Annex 1 compliance, they ensure sterility and closure integrity. Suitable for fully automated versions, these systems can be integrated with isolators or RABS and they are able to manage different types of drug products and combi devices with both in-line powder and liquid filling.

Inspection and coding machines combine automated visual inspection with data printing and serialisation in full compliance with drug product traceability. They detect cosmetic defects while applying laser or inkjet codes for traceability. Usually integrated downstream of aseptic lines, these machines allow for product quality and regulatory adherence.

Tray loading systems organise containers like vials into trays for batch transport.  Designed for flexible line configurations, these systems can operate at high speed and be integrated with upstream or downstream units.