Pharma Focus Asia
Klöckner Pentaplast - Pentapharm® alfoil® films

Toxic-sterile ChargingIsolator for Preparation Vessel

Tailor made solutions for your needs

FPS is an Italian company specialised in the design and manufacture of containment systems and micronisation solutions for the handling and production of active pharmaceutical ingredient and sterile pharmaceuticals; FPS is focused on pharmaceutical, biotech and chemical companies all over the world. Eighteen years after its foundation, FPS has three sites: the headquarters in Como, a large production plant in Fiorenzuola d'Arda (Italy) and a sales office in Philadelphia (USA).

With almost 100 employees and over 1,300 systems in operation worldwide for handling pharmaceutical substances, FPS has remained very flexible and can easily adapt to very different customer needs.

FPS has recently designed a toxic-sterile charging Isolator for a preparation vessel. The user, a Pharmaceutical European company, needed to weight & charge a High Potent API into a process vessel under Grade A-ISO 5 conditions.

After carefully listening of the customer needs and studying and the challenges of their process, we highlighted the most critical:

- Keep the product sterile during the process (10-6SAL)
- Protect the operator from High Potent API (OEB 5)
- Avoid back injuries (because of heavy bags handling)
- Risk of cross contamination from processing different products.

After this initial analysis, we used our deep experience in this field to design the isolator, challenge our solution through an ergonomic study (testing with the user on a mockup model at scale) and we proceeded with manufacturing.

The solution proposed by FPS nullifies the risk of exposure for operators. As a result, they don't need to use PPEs which creates better ergonomics and leads to higher productivity. In addition, the system can assure Grade A sterile conditions inside each isolator chamber by using an integrated VPHP generator. Finally, the system can be used for Potent-Sterile API because it can operate both under a positive or negative pressure regime. Another useful feature: the isolator-Vessel connection doesn’t interfere with the loading cells.

The custom isolator hosts a VHPH generator & H14 HEPA filters and a CIP/WIP system to avoid cross contamination.

It works in positive pressure, so the product is kept sterile during the entire process, but the isolator can switch to negative pressure during CIP/WIP to protect the operator.

Heavy bags are moved on a stainless-steel cart inside the isolator and the process vessel has loading cells for accurate weight.

This special connection between the isolator and the Process vessel assures containment but also sterile conditions and avoids affecting the load cells.

"Our extensive experience in containment and a very close collaboration with the customer allowed us to design an isolator that can maintain the API sterility and protect his operators without using additional PPE," says Stefano Butti, FPS Sales Director. "This design also avoids the risk of cross contamination that can occur when processing different products. This solution is the perfect combination of optimum productivity and total safety."

--Issue 43--

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