#advanced compliance

IMA Life is able to supply complete lines: from the initial washing of bottles, through depyrogenation, filling, capping, etc. … up to and including secondary packaging. All this with or without freeze-drying systems and, in the part where the product is exposed, using an isolator. Isolated solutions are applied to production lines for aseptic and non-toxic products and increase the safety of the final product, ensuring improved aseptic standards and lower operating costs.

All the equipment is produced inside the IMA Life facilities, which is a key factor today. Although we were not among the first to address this market segment, we have come up with a solution that is still unique today. Our isolators have “6 faces” (six walls) in view of the fact that the base of the cube-like structure is also the base of the machine which will then be integrated. This technical detail ensures greater sealing capability, avoiding gaskets between the isolator and the base of the machine, which are present in all other solutions on the market.

Towards a “gloveless” solution implies that the enclosed, fully automated aseptic processing can run completely without human intervention. Therefore, a highly automated machine like INJECTA requires a very minimal presence of gloves around its filling & stoppering “isles” thanks to its reliable, fully robotic system. Some gloves are installed for emergency access or cleaning, but they are not necessary during the production process.

INJECTA is perfectly integrated with IMA Life’s 6-sided isolator with reduced shell width, minimizing the presence of gloves.

INJECTA is designed to run with no mouse holes, conveyors, glass-to-glass contact or vibrating bowls which all create risks to the batch.Its multi-axis robotic arms are able to execute the safe, ergonomically uncompromised movement of difficult-to-handle containers offering also repeatability with the flexibility to easily change the process or the container type being filled, so as to efficiently produce high-mix batches. In absence of traditional, mechanical components, decontamination cycles are much shorter too.

“Glovelessness” implies that isolators can run much cleaner than a conventional isolator and be completely closed. All product contact parts are sterilised in place, avoiding need for an operator to directly enter the classified aseptic clean space. All of this drastically reduces the likelihood of a source of microbial contamination. In other words, sophisticated robotic systems operating in an isolator system, can ensure not only outstanding sterility assurance and product safety, but also product outcome reliability in commercial scale production.

INJECTA design is on a pathway leading to fully automated aseptic processing, towards a gloveless system that tends to run without any form of human intervention. Results: cost and time saving, major safety for operators and, thanks to the isolator environment, an increase in product quality and safety.

In the pharmaceutical industry, aseptic processing is monitored—in accordance with regulatory requirements—to prove the environment surrounding a process does not negatively impact product quality and, ultimately, patient safety. Environmental parameters monitored include temperature, relative humidity, differential pressure, and airborne particles. Annex 1, FDA and cGMP’s guidance on Aseptic Processing give special attention to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels for viable and non-viable environmental and process monitoring. Compliance to these regulatory guidelines, which require continuous monitoring of airborne particle cleanliness, has been a driver for pharmaceutical companies to install facility monitoring systems.

Optical particle counters have historically been the only way of monitoring the cleanliness of the air in real time in pharmaceutical applications. These instruments are installed, based on the principles of quality risk management (QRM) in locations where there is the greatest risk of airborne particle contamination to the process. These instruments could not determine particle viability; they can only count and size particles in real-time.

Recently, the commercialisation of a new technology based on Laser Induced Fluorescence (LIF) has made it possible to look at airborne viable microbial counts in real time. Real-time alarms notify facility operators of alert limits to enable an immediate response to an unwanted event or excursion. Real-time viable particle counters not only offer the potential to monitor these very clean and controlled environments, but can also provide continuous data when integrated into a facility monitoring systems FMS System. 

INJECTA is ready to interact with new real-time airborne viable particle counting technologies to quickly react to possible microbial excursions

Approval of this technology will result from discussions between the pharmaceutical companies and the authorising bodies. IMA Life is carefully evaluating applying the technology to the current machines, whereas it will be part of the design criteria for all pipeline projects.

The potential to instantly respond to an airborne microbiological event when it happens is exciting – and beneficial: it improves process understanding and enhances process knowledge. Result is an increase in product quality, a safer product, and risk reduction.