In the pharmaceutical industry and in the regenerative medicine it is a technology that provides a physical barrier between a process that may have asepsis and/or toxicity requirements and the external environment. D.F. S.r.l. provides cutting-edge customized solutions.
- AISI 316L stainless steel working chamber with rounded corners, frame and external covers in AISI 304.
- Opening front window in safety glass with gas bumpers for lifting and sealing.
- Inflatable rubber gaskets suitable for the treated products.
- Internal lighting with low consumption IP65 led lamps.
- Peroxide resistant materials and tools in case of sterilization.
- Bag-In/Bag-Out (H14) filters with retention rate > 99,999% at 0.3 μm, DEHS tested, at all intake, exhaust and circulation stages: the circulation air is filtered twice with parallel filters, while the exhaust air is filtered twice with series H14 BI/BO filters for safety guarantee. All filters are equipped with connections for integrity testing in place and are controlled with differential pressure transmitters. Fan speed can be adjusted automatically to compensate the increasing filter clogging, keeping laminar flow conditions and correct ventilation. The control PLC manages delivery and output to keep the correct internal pressure difference. Setting for disinfection includes sealing on the inlet and outlet channels through servo controlled valves, internal inflating function with gasket sealing check (Leak Test), installation of a temperature/humidity probe and use of peroxide resistant materials. It is possible to connect VHP systems or use the Dry-Fog DF integrated system. CFR21 Part 11 compliant PLC/HMI control.
- *Accessories: metering peristaltic pumps, scales, particle counters, oxygen, humidity and temperature probe, glove integrity test.
The IS series isolators are suitable for treating products in a controlled environment with external operator and can be configured according to the customer’s needs. Product sterility is ensured by sterilizing the working chamber and by keeping Class A conditions (EC GMP) during the entire working cycle. The internal pressure is monitored continuously and is kept within the set thresholds by adjusting the delivery and output fan speed, preventing untreated air from entering the chamber. Isolators are always customized in: size, accessories, tools, internal finishes, number, type and position of gloves, process connections (material loading module – SAS or doors for inserting components – RTP), connections for residues discharge with continuous bag and for washing drain.
GLOVE TEST CONSOLE - GIT
The Glove Test console Mod. GIT allows checking glove integrity through the pressure drop method according to standard ISO 14644-7.
Minimum detectable hole: 50 microns. With a duration of more than one hour, it can be used in Clean Room without electric and pneumatic connections, with internal battery charger and compressor.
It is available in models with 2, 4 or 6 stations with special pads for the isolator flanges of the gloves to be tested, with inflatable gasket and Staubli quick coupling fittings to the console. Available with temperature probe.
CFR21 Part 11 compliant PLC/HMI control Up to 6 tests carried out simultaneously and possibility to print the test report locally or remotely with Wi-Fi connection.
On-board station available to test new gloves not installed yet.
The DRY-FOG system ensures the sterilization of the surfaces it comes in contact with by lowering the bacterial load achieving a 6 log reduction.
A special nozzle converts the disinfectant/sterilizing product into dry fog.
This ULTRAFINE ATOMIZATION allows obtaining product drops smaller than 10 µm. The smaller the particle size, the higher their moving ability. Random collisions allow the disinfectant particles to reach all internal surfaces, even the most hidden ones, ensuring a safe and repeatable sterilization.
Moreover, very small sterilizing particles do not break but bounce when colliding with surfaces. As a consequence, the system does NOT wet surfaces and long drying time is NOT required at the end of the contact phase, dramatically reducing the sterilization time.
cRABS (Closed Restricted Access Barrier Systems) are used to keep a specific working area in class A environment, with laminar air flow, controlled ventilation and slight overpressure to prevent external contamination of the areas where the processed containers pass from the production line.
In order to optimize the distribution of the parallel laminar flow, doors are double and are equipped with suction systems in the space between the external part (sealed
with inflatable gaskets) and the internal one (sealed with close cells rubber gaskets).
The operator access is allowed through gloves.
As for isolators, absolute filters HEPA H14 for delivery, output and lamination and controlled speed fans are used.
Air is partially ejected and partially recycled.
Through the HVAC connection, it is possible to condition the air in the working area.
Viale L.Landucci,4 Siena
Ph.+39 0577 375528
Fax +39 0577 374426