Harmful API particles escaping from uncoated tablets during bottling or blister pack operations is a growing threat in many pharma packaging facilities.
Looking for an alternative to conventional hard shell isolator technology Solo Containment has developed an engineered acrylic containment system that combines total process visibility with what it calls exceptional API containment.
The company says that occupational exposure data from recent installations proves that the Solo system attains OEB 5 containment standards during tablet bulk loading , vibratory feed and final fill/packing operations.
Using multi-stage HEPA filter exhaust airflow the Solo packing line isolators create a safe negative pressure airflow around all API exposed parts of the packing operation. Visibility through the cast acrylic isolator walls is unrestricted and operator access to load hoppers and set up stations are contained by full arm length glove access developed from ergonomic trials at the design phase.
Recognising that one of the major particulate escape sources is tablet hopper loading Solo has developed solutions for contained tablet in feed using both the EziDock CSV systems as well as RTP canister technology. These systems permit routine replenishment of bulk tablets with close-to-zero aerosol escape.
In a recent SMEPAC test with a US client, the Solo system registered a reduction in operator exposure from an unacceptable 16 micrograms /M3 with the un contained process to levels below 10 nanogram m3 with the containment isolator in place.
The Solo system has already been applied to high speed blister lines, large-scale micro tablet cassette fillers and conventional tablet bottling lines. In all cases, says Solo Containment, the clients have enjoyed significantly lower construction costs as well as faster delivery cycles than would be the case with conventional isolator technology.
While the engineered acrylic solutions Solo provides are ideal for high volume lines operated on a bulk campaign basis, clients in the CRO or clinical trials sector seek a single campaign duration system that avoids any risk of batch-to-batch API cross contamination.
At the CTS facilities, the Solo team has harnessed the same total transparency, negative pressure and multi HEPA filter airflow principles and constructed the containment from flexible film complete with welded in glove access sleeves, load airlocks and waste disposal sleeves. Solo’s flexible film filling line isolators are constructed from FDA compatible anti static films that may be attached around the filling machine, capsule filler or blister machine in minutes, giving a fast track change over at each campaign change.
The engineered acrylic and soft wall packaging isolators are subjected to design review, ergonomic and task efficiency verification and detailed operator training.