Autoclaves/Sterilizing Ovens/Freeze Dryers

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Autoclaves/Sterilizing Ovens/Freeze Dryers [19]

FEDEGARI Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40
Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40
23-836
FEDEGARI
FXOAF6/CO40
2016

Fedegari FXOAF6/C040 air steam mixture autoclave/sterilizer of 2016
Applications: Bio-Pharmaceutical
Loads: Large parenteral volume, Blood bags, Syringes
Processes: Sterilization
Sterilization of aqueous solutions in sealed containers (such as LVPs, vials, PFS, blister packs, etc.) turns out to be critical for a very specific reason: the pressure inside the primary container is higher than the saturated vapor pressure outside and at the same temperature. This could affect the product and/or the container itself, with the risk of deformation.
Hence our unique approach to back pressure sterilization:
- Flexibility: control of critical process parameters to ensure maximum flexibility of the sterilization cycle and avoid unwanted container deformation/damage by applying the most appropriate heat treatment to the product.
- Total control: total temperature and pressure (steam + air) control. A flow diverter and one or more fans ensure uniform diffusion of the mixture.
- Process optimization: The load comes out dry and ready to use.
- Integration & validation: prevalidated and standardized Thema process controller for all our machines.
- Internal chamber surface is mechanically polished with a roughness of less than Ra <0.4 μm.
- 2 doors, automatic sliding, to best optimize the available space.
- 5 RTD PT100 probes for temperature control in the chamber and in the product (3 flexible + 2 fixed).
-Automatic air filter sterilization complete with fixed thermo-probe in the filter bell to monitor the temperature inside the filter.
- 2 passages for validation sensors.
- Door sealing ensured by Fedegari's unique and patented profile gasket.
- Exclusively patented gaskets from Fedegari that guarantee 100% door sealing. These gaskets are FDA compliant and additionally USP Class VI compliant.
- All stainless steel 316L- 1.4435 and 316L - 1.4404 plumbing system with exclusive quick connections and silicone gaskets.
- Equipped with one or more fans in relation to the chamber size, with patented magnetic drive ventilation system, without through-shaft in the chamber: ensures better sealing in the chamber, reduces maintenance frequency and does not require lubrication.

FIELDS OF APPLICATION.
The FOA air-steam mixture sterilizer is suitable for:
- Sterilization of parenteral solutions, liquids in closed non-deformable containers (e.g., glass tubes) and liquids in closed deformable containers (e.g., plastic bags or bottles).
- Terminal sterilization of pre-filled syringes.

Specifications:
indicative thermal dissipation, doors closed: side 1 - 0.9 kW, side 2 - 0.9 kA,
Maximum operating pressure: 3 bar g
Approximate weight of empty autoclave 5000 kg
Power supply 400 V 50 Hz , 19 kW

Rif description required
pressure (bar g) Flow rate size
P1 water recovery from chiller 1,5 120 l/min 34.8x1.65
P1 water from chiller for exchanger 2 120 l/min 34.8x1.65
G water for empty pump 2 20 l/min 15.75x1.65
E1 industrial steam for intercapendine3 250 kg/h 22.1x1,65
E1 saturated steam ( 95-97%) 3,5 800 kg/h 47.5x1,65
D1 oiled compressed area for tools 5,5 100 NL/min 9.4x1.65
D oiled compressed area for chamber3,5 300 NL/min 34.8x1.65
A general discharge 72.9x165

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DE LAMA autoclaves DE LAMA DLST
autoclaves DE LAMA DLST
23-1235
DE LAMA
DLST
1999

DLST/L Series (Class 100 - ISO 5) dry heat sterilizers are designed in accordance with cGMP Prescriptions to meet the multiple needs of the Pharmaceutical Industry and to perform the following treatments: Dry heat sterilization is an ecologically non-polluting process that does not generate waste or inconvenience problems for the environment or personnel. At the same time, the process fulfills the most stringent requirements for bacterial load reduction. Possibility of realization in execution suitable for continuous operation up to 300°C with the use of HEPA filters equipped with special sealant. Main applications: empty glassware (e.g., vials, bottles) stainless steel accessories (e.g., trays, machine parts) various moisture-fearing materials basic pharmaceuticals and thermostable chemical compounds non-aqueous liquids (e.g., oils, glycerins, etc.) The chamber is available in horizontal execution. Only components of the highest quality and reliability, available internationally, are used in the construction of De Lama sterilizers to ensure ease of replacement and maximum system life.

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DE LAMA Autoclaves/Sterilizing Ovens/Freeze Dryers DE LAMA One door only
Autoclaves/Sterilizing Ovens/Freeze Dryers DE LAMA One door only
23-1233
DE LAMA
One door only
1999

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BOSCH Autoclaves/Sterilizing Ovens/Freeze Dryers BOSCH HQL3240
Autoclaves/Sterilizing Ovens/Freeze Dryers BOSCH HQL3240
24-1294
BOSCH
HQL3240
1995

DEPYROGENATION TUNNEL BOSCH HQL 3240 HQL installations are ideal for the sterilisation of vials. This model is exceptional because of the low throughput in the tunnel, which is the result of the laminar hot air flow process with its high degree of efficiency. Sterilisation tunnels are used on filling lines in the pharmaceutical industry to sterilise glass containers prior to aseptic filling. These tunnels use forced air at temperatures of up to 350°C. Bosch HQL drying and sterilisation tunnels operate with unidirectional flow, with process curves of temperature progression and significantly reduced sterilisation times. They guarantee the constant precision required for validation, qualification and reliable production capability. Through a filter, make-up air is introduced into the tunnel. Inside the tunnel, the air, drawn in by fans, feeds the supply and cooling section through pre-filters and particulate air filters in separate areas of the tunnel. Using the laminar flow principle, the air flow is directed vertically into the containers. Underneath the conveyor belt, the air is directed back through a recirculation duct to the fan. The fans need fresh air for the heating section: laminar flow unit. The heating elements in the recirculation duct serve to heat the recirculation air to the preset temperature. Below the particulate air filters there are heating elements with an outlet to a temperature control and recording device. The cooling section operates with laminar flow. A fan in the cooling section exhausts the hot air under the conveyor belt. The exhaust air volume is automatically adjusted. The tunnel is equipped with an automatic overpressure control in the cooling section. Modular system for tunnel assembly suitable for the required power range with optimum energy consumption. GMP-compliant construction. Compatible container transport systems for stable and unstable containers. Safe conveyor belts on floor and side levels operated simultaneously. Excellent accessibility and ease of operation. Technical data
Length 2865 mm
Width mm 2200
Height 2630 mm
Weight Kg 2500

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INTIMAC s.r.l.

Via XXV Aprile, 8

21054 Fagnano Olona (VA)

Italia

Tel. +39 0331 1693557

email: inti@intisrl.it

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