CSV Containment provides three DIT® reactor charging stations with double chamber for a new department for HPAPI production.
DIT® reactor charging with double chamber for HPAPI production is the safest way to charge drums, even of different diameters, without changing any part of the equipment. The DIT® dual-chamber configuration allows for a unidirectional handling flow of drums and powders, from clean to dirty. This causes the charging chamber to be segregated from the pre-chamber and drum, which is never exposed to potential contaminants. A very high level of containment is thus achieved, up to OEB6.
For this reason, a newly built Facility in northern Italy has chosen CSV Containment to realize no less than three double-chamber, double-iris rigid isolators. Although these are twin stations, each one is dedicated to a specific reactor, taking into account all the constraints around the charging point, its size, as well as its orientation. Three glove boxes with automatic irises and pre-chamber drum inlets have been placed in the state-of-the-art pharmaceutical manufacturing plant.
Each station has been designed to facilitate the work of the operators as much as possible. Indeed, their design is meant to provide convenient access to the chambers for reactor charging and offer adequate space during bag-out operations. In addition, bag handling inside the isolator is designed to be unhindered, thanks to the inflatable seal that allows the metal profile usually used around the inner door to be eliminated. In this way, the floor of the two chambers is clear of clutter and bags can be conveniently moved without having to overcome obstacles.
In the fabrication and assembly workshops, additional investments have been made in equipment and training to implement the skills needed to make containment systems. This is to make the production times faster and increase quality control. In addition to rigid isolators, CSV Containment also makes plastic and flexible accessories, such as those for the bag out, in-house. That is not to say that the client’s needs and requests are neglected: certified material supplied directly by them can also be used for custom-made liners. Recent Twin Tie closing systems complete the product range of offerings, all made by CSV Containment.
Test and assistance.
Lastly, it is noteworthy that the testing and validation phases are also entirely performed by CSV Life Science Group staff. In particular, after the installation, the stations are subjected to SMEPAC testing by CSV Containment’s in-house team. Customer support continues in the after-sales phase and, through the constant exchange of information with the operators themselves, aims to make the work experience increasingly satisfactory. Its great flexibility allows CSV Containment to quickly identify solutions for any critical issues or customer needs accruing during the use of the supplied products. This flexibility can be seen in all the products, like the continuous liners available in different shapes, sizes, and square footage and the separation solutions that are universal and adaptable, meaning one model for different types of use.
DIT® reactor charging main features:
- Pre-chamber equipped with 2 glove ports and 2 gloves
- Fully automated drum handling via DIT ® system (double iris)
- Universal iris size to fit all drum diameters and heights
- Flat interior workbench with no constraints between chambers thanks to the door equipped with an inflatable seal
- Reactor charging chamber equipped with 3 elliptical glove ports and 3 gloves
- Frontal panel fully openable (150° at least) and equipped with proxy safety switches and safety interlocks
- Chambers operating in negative pressure assuring a pressure cascade, and purged by Nitrogen
- An O2% transmitter interlocks transfer and charging operations
- Negative pressure realized by variable speed fan, one for each chamber
- External LED lamps placed on the top through a clamped sight glass
- Extraction passing through HEPA (H14) filters in push-push safe change configuration
- Full GMP standard (round shaped corners, mirror finishing and compliant materials)
- Chambers equipped with PTFE Spray Gun, connected via PFA hoses
- Rotating Spray Balls installed on the top
- Continuous lining on a DN300 slotted steel container for transferring waste/dirty materials out from the chamber
- Continuous liner port internally covered by a conductive cap hooked on the inner chamber surface to open the liner ports just when necessary
- Contained separation kit made of a special tool , a cutter and twin tie devices made by CSV Containment
- Contained separation kit consisting of a special tightening tool, a cutter, and twin tie devices produced by CSV Containment
- HMI (ATEX-rated touch panel) on board
- Control system to manage and monitor P&ID, negative pressure, O2% measurement, inertization cycle, leak test, interlocks related to any inflatable door and seal, reactor charging valve status (open and closed).
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: firstname.lastname@example.org