The project provided some interesting insights into working with a group of people from several different disciplines, not all of who were used to understanding the possible options in order to outline and create the requirement for the 'ideal' solution.
The project was an active vaccine process for veterinary products that needed European GMP Grade A process requirements and operator protection. The product weight and size was the major ergonomic problem to resolve especially as there were two stages of processing.
Space and ease of manipulation were as always the overriding factors. Containment via the Bassaire patented seal system and manufacture due to our own in house expertise allowed Bassaire to focus on the customer's needs, which developed as the project progressed. The resulting unit is effectively two isolators interconnected. A transfer isolator where a glass demijohn 200mm diameter x 460mm high weighing 30 kg or so containing sealed product along with other items is passed and 'locked in'. Here the items are sanitized and gassed.
The demijohn has a stirrer that operates constantly through this cycle. Once gassing is complete the demijohn is transferred via a lockable trolley system to the main isolator. Here the product vessel is connected to a sterilised filling loop after the product has been modified to meet its specification.
Within this facility temperature and pressure monitoring is indicated constantly and both isolators provide European 'Grade A' conditions. The construction even with the large access doors performed to a high integrity (a pressure loss of less than 50 Pascal's from a 1000 Pascal test pressure when corrected for temperature and ambient variations) above the medium integrity originally specified.
Constructed from 4mm 316C stainless steel the unit has a 1.6µ bead blast finish.