IMA Life IsoTech Lab

a. Isolators make it easier to achieve GMP Annex 1 requirements than RABS technologies. By implementing more stringent hygienic design solutions and especially by integrating automated decontamination methods.
b. Isolators are able to maintain aseptic requirements for a greater duration, thereby enabling longer and more efficient campaigns.
c. Isolators can implement temperature, humidity, pressure and pressure cascade configuration requirements that are not possible with other technologies.
d. Decreasing costs: class C instead of Class B surrounding the filling area requested for RABS approach. 

1. Lower air-conditioning costs.
2. Lower gowning time.
3. Lower cost for gowning material.
4. Fewer particle and microbiological monitoring requirements.

a. Unlike closed-RABS, isolators can achieve higher containment levels and be suitable for OEB requirements of 5 or more.
b. They can be used more easily in high bio-containment environments such as BSL-2 or BSL-3 facilities.
c. They can include automated or semi-automated washing systems for toxic risk reduction at the end of production or automated VPHP-based deactivation solutions in the case of biological products.
d. They are equipped with mechanical design, ventilation and sealing systems superior to any closed-RABS.

a. Isolation and RABS technology can physically separate the operators from the filling area, thereby reducing contamination risks. But isolators are able to guarantee protective positive pressure conditions and validated, integrated decontamination able to increase the sterility assurance compared to other technologies.

a. IMA has decided to manufacture complete filling lines, including the isolator. One of the major benefits of bringing all parts design and manufacturing activities under one roof is the resulting harmony between single machines in the line. All the aseptic procedures, as with sterile material introduction into the isolators, are carefully analysed and studied during extensive mock-up activities, decreasing training requirements and increasing risk management.

a.“SAL 10-6” is achieved by means of a validated and repeatable cycle as requested by GMP Annex 1.
b. Results are not dependent on the operator.
c. VPHP can be used at the end of production to reduce biohazard risks.

a. Yes, the delivery is generally 2-3 months longer: depending on the actual line configuration.

a. The cost-saving is accomplished by virtue of:

1. Fewer batches being discarded for reasons linked to lack of sterility: this data is not quantifiable, as it is human-dependent and strongly related to the value of the actual products being handled.
   A single exercise can be recommended: calculate how much money can be saved if a single batch per year is saved thanks to the isolator.
2. Investments generated by the environment downgrade (HVAC + gowning time plus material & environmental monitoring): some of the major pharmaceutical companies have declared in public conferences that their savings can be estimated as being between 1 and 1.3 million euro per year (this amount is valid for EU and USA, in other countries it might be different).

All this means that the cost savings entirely pay for the isolator itself after just a few years of operation.