Syringe filling and sealing machine (injector/sterile area) KUGLER FVA 101,
max. 4200 pcs/h
dosing range 3-26 ml
accuracy +/-0.5%,
filling: liquid/viscous/ointment,
formats: 10/20 ml,
closing station, plastic injectors, dosing pumps, sorting vibrator, feeding station, individually transported to work stations in cycles, test stations, storage bunker (200Lt, for approx. 1500 injectors, 380V/50Hz, 3-Ph,
working height 900 mm +/- - 50 mm, 1500 kg (Kugler),
Inspection Machine Seidenader V90-AVSB for prefilled syringes
From the infeed system, the product is conveyed through the inspection cabin on a continuously or intermittently moving transport system, consisting of a dual chain system fitted with white or black rollers. Each roller rotates on two precision roller bearing assemblies. The rollers are supported between dual conveyor chains.
Several lighting systems are available on option: A white light source provides diffused illumination from behind the rollers to allow inspection against both a white background (light source) and a black background (the rollers) or vice versa to meet GMP regulations.
Alternatively, highly concentrated halogen light can be shot through the bottom or shoulder of the containers, to reach the "Tyndall Effect". In addition to these lighting systems, mirrors, a magnifying lens and polarisation filters are available to optimize the inspection and to support the operator.
The product passes through the inspection cabin in front of the operator. This arrangement permits the inspection of the entire outer surface of the product.
The rejected product is easily removed either by hand or by an automatic reject system operated by infrared sensors.
The product is fed out of the inspection cabin, brought into upright position and is then transferred into various discharge systems: accumulation tables or trays.
Operators: one. Output: max. 150 objects/min/lane. Construction: stainless steel. Mode of operation: continuous or intermittent (switch). Voltage: 230 V, 0.8-1.4 kW, 50 Hz standard (all desired voltages possible). Working height: 900 mm ± 50 mm. Dimensions: ca. 2300 x 1000 x 1700 mm. Weight: ca. 550 kg net.
Intermettient motion capping monobloc from
Technical data
Mechanical speed 90 strokes/min
Power absorption 4,5 kW
Air consumption 200 Nl/min
Air pressure 5-6 bar
Gross weight 1950 kg
Size range
A from 20 min -70 max
B from 15 min -80 max
C from 35 min -180 max
Diameter 15 min -80 max
The ConiWitt is a high-performance, high-quality conical sieve mill that is used for deagglomerating and sizing granular products to finenesses of up to 150 μm.
Thanks to its compact and modular design, the ConiWitt is easy to integrate in complete process plants. With its extraordinary diversity and high performance, this
conical sieve mill can be used in any demanding milling process, whether for achieving optimum grain size distribution or high flow rates, as well as for milling temperature-sensitive products, or potentially explosive substances.
THE ADVANTAGES OF THE CONIWITT
- Very broad scope of application ranging from all types
of dry to wet and sensitive powders
- Diverse usage possibilities ranging from stand-alone and inline to integration in complete installations
- Clear GMP-capable concept for smooth, reproducible production including scale-up
- High level of production safety thanks to certified ATEX construction for Zone 0/20 and a MIE range down to > 1 mJ
- High level of operational safety for containment requirements up to OEB 5 (< 1 μg/m3)
- Easy and quick cleaning - Washing in place (WIP), CIP, SIP optionally available
- Ultimate production flexibility due to the modular design
- Versatile usage due to a large selection of milling elements, which can be changed easily and quickly
- Energy input reduced and optimised, guaranteeing reduced heating of the product
PROCESS CHARACTERISTICS
Particle size range 5 cm-150 µm
Throughput
ConiWitt-200 1000–2500 kg/h
Density up to 2 kg/dm3
Temperature range product from −20 °C to +60 °C
Dimensions
L x W x H (m) : Frewitt screening plant
0.9 x 1.5 x 2.0
1,0
Trolley
1.1 x 0.8 x 2.1
0,4
The STMC Compressed Steam Distiller, (system also described as “steam recompression distiller” or “steam thermocompression”, or even more generically “thermocompression still”, produces distilled water suitable for pharmaceutical applications (A.P.I.) and parenteral preparations (LVP, SVP). It is an ideal technology for any injectable product based on WFI (Water For Injection) and for special solutions where both quality factors (such as sterility and elimination of pyrogens and low molecular weight chlorinated solvents) and economic factors (low management costs) are critical for the competitiveness and success of the pharmaceutical process.
Voltage 400 V 50Hz Power 46 kW Compressed air 6 bar NL/min 3 Max steam heating 3 bar Weight 4100 Kg. With Bram Cor accumulation tank model STOC WSTP 10000 The BRAM-COR product range also includes a complete selection of Mod. STOC tanks/vessels for the collection of both pharmaceutical (WFI-PW-HPW) and process water. Traceability, material and component certification are values of all BRAM-COR installations. Strict welding and sanitary piping control procedures are applied in the production of the vessels, with non-destructive testing and in accordance with international standards for pharmaceutical equipment. Basic feature of all BRAM-COR tanks is that they are completely washable. In addition: Surfaces and components in contact with the products are certified in mirror polished AISI 316L stainless steel (Ra ≤ 0. 4 μm)Construction ‘Tank in Tank’ Vertical design Heating/cooling jackets with AISI 304 satin steel finish Technical data: Tank capacity 10707 litres Double jacket capacity 694 litres Max operating temperature tank 143 C° Max operating temperature jacket 143 C° Hydraulic test pressure tank 5 bar Hydraulic test pressure jacket 5 bar Material AISI 316L Pressure safety valve 2.5 bar Including water distribution pumps
The Evaporation Column is designed to minimize steam velocity to avoid entrainment of water particles, which are separated from the steam by a special separator. In a double tube plate heat exchanger, the heat from the steam heats the pretreatment water by heating it above boiling temperature, generating pure steam which expands in the evaporation column. The average heating of the DTS exchanger is usually determined by the industrial steam of 100 to 120 psig (6 to 8 bar).
Voltage 400 V 50Hz Power 1.1 kW Compressed air 6 bar NL/min 2 Max steam heating 6 bar Weight 1000 Kg.
- Drinking water release pump for water softeners
- Inlet and outlet drinking water pressure gauge
- N.2 glass fiber tanks with ion exchange resins
- Polypropylene tanks with delivery pump
- Sweetened water filtration and pre-filtration system Manufacturer: FLUXA FILTRI SPA Model: 5FA3S50 Serial: SN-R1150
- Design pressure: 10bar
- Design temperature: 80°C
- Hydraulic test pressure: 11.3bar Capacity: 34,91liters Quantity of filter elements. : 5x30"”
- 100lt polypropylene container for sodium metabisulfite with feed pump.
This water pretreatment comes with the tank (24-1716)
Accumulation tank Bram Cor modello
STOC PSSA 3000
The BRAM-COR product range also includes a complete selection of Mod. STOC tanks/vessels for the collection of both pharmaceutical PW-HPW) and process water. Traceability, material and component certification are values of all BRAM-COR installations. In the production of the vessels, strict procedures are applied for welding and weld control.
welding and sanitary piping control procedures with non-destructive testing and in accordance with international standards for pharmaceutical equipment are applied in the production of the vessels. Basic feature of all BRAM-COR tanks is that they are completely washable.
In addition:
Surfaces and components in contact with the products are certified in stainless steel AISI 316L polished
stainless steel AISI 316L mirror polished (Ra ≤ 0.4 μm)
Tank in Tank’ construction
Vertical design
Technical data:
Tank capacity 3649 Litres
The BRAM-COR product range also includes a complete selection of Mod. STOC tanks/vessels for both pharmaceutical (WFI-PW-HPW) and process water collection. Traceability, material and component certification are values of all BRAM-COR installations. Strict welding and sanitary piping control procedures are applied in the production of the vessels, with non-destructive testing and in accordance with international standards for pharmaceutical equipment. Basic feature of all BRAM-COR tanks is that they are completely washable.
In addition:
Surfaces and components in contact with the products are certified in mirror polished AISI 316L stainless steel (Ra ≤ 0.4 µm).
Tank in tank” construction
Vertical design Heating/cooling jackets with satin-finished AISI 304 steel finish.
Osmosis system sold together, it can be found as (24-1463)
Tank Capacity 10707 Liters Double jacket capacity 694 liters Max working temperature tank 143 C°. Max working temperature jacket 143 C°. Hydraulic test pressure tank 5 bar Hydraulic jacket test pressure 5 bar Material AISI 316L Safety valve pressure Including water distribution pumps 2.5 bar
BRAM-COR is committed to providing a clear answer to all water treatment needs for the production of pharmaceutical water or water for other critical applications (cosmetics, healthcare, human food and animal feed, for example). Our approach is truly focused, with a wide range of specific expertise. BRAM-COR's CROS sanitary reverse osmosis systems, in particular, are designed to produce purified water (PW) and also water for injection (WFI), through different water treatment stages, depending on specific feed water qualities and specific production needs.
In particular, Mod. CROS plants with pharmaceutical reverse osmosis technology (Sanitary Reverse Osmosis Systems) produce extremely cost-effective and efficient purified water (PW) and, with the downstream addition of an additional ultrafiltration (UF) aqua ad injectabilia (WFI).
CROS operate through different stages of water treatment, both in relation to the specific quality of the feed water and to the particular production needs. The treatment stages required to separate water from high or medium molecular weight organic substances, to separate it from ions and pyrogenic bacteria, include: Sodium hypochlorite dosing stations: for water disinfection and oxidation of organic substances, for water disinfection and oxidation of organic substances, reducing the bacterial load Sodium metabisulfite dosing stations: for chlorine neutralization Double filtering system: to remove particles from the inlet water Single or double stage osmosis Continuous electro-deionization UV lamps Sterile final filtration -0. 22µm In each stage of reverse osmosis (RO), water is treated through composite membranes formed by thin films (TFC or TFM), capable of providing the highest retention of contaminants. Two different streams are generated by the RO system: permeate, corresponding to the specific PW, and RO concentrate, which is recycled back into the system to achieve higher recovery with lower inlet water consumption. An additional osmosis stage can be added to reduce water waste through the concentrate.
Accumulation tank sold together, can be seen on our sitto with 24-1470
Accumulation tank Bram Cor modello
STOC PSSA 10000
The BRAM-COR product range also includes a complete selection of tanks/vessels Mod.
STOC tanks/vessels for the collection of both pharmaceutical PW-HPW) and process water.
process. Traceability, certification of materials and components are values of all BRAM-COR systems.
all BRAM-COR plants. In the production of the vessels, strict welding and welding control
procedures for welding and sanitary piping control are applied in the production of the vessels, with non-destructive test
testing and in accordance with international standards for pharmaceutical equipment.
pharmaceutical equipment. A basic feature of all BRAM-COR tanks is that they are
completely washable.
In addition:
Surfaces and components in contact with the products are certified in mirror-polished AISI 316L
stainless steel AISI 316L mirror polished (Ra ≤ 0.4 μm)
Tank in Tank’ construction
Vertical design
Technical data:
Tank capacity 10495 Litres
Max working pressure ATM
Max working temperature tank 40 C°.
Material AISI 316L
Voltage 400 V 50Hz Power 30 kW Compressed air 6 bar NL/min 0,8 Weight 1300 Kg. Retracted water flow 5000 liters /h
type of superheated water rain autoclave sterilization machine
model fow5 sp
manufacturer Fedegari autoclavi s.p.a.
nominal dimensions of the mouth (l x h) 1300 x 1500 mm
chamber depth 6900 mm
type horizontal sliding doors
max chamber working pressure 3 bar rel
voltage 400 three phase (std)
frequency 50 hz (std)
degree of protection of electrical equipment ip54
safety and electrical devices according to ispesl safety
safety devices according to ispesl safety standards
ispesl pressure body certifier
general description
The sterilizers of the FOW series are prepared for
sterilizing with superheated water rain under counter pressure and,
and are therefore suitable for the treatment of materials and containers that are
materials and containers compatible with contact with water during sterilization
contact with water during sterilization and which would be damaged in saturated steam cycles due to the
saturated steam cycles due to the internal pressure of the containers themselves.
containers.
The sterilizer (cf. Figure 3.1) consists of the following components.
main components:
-- Sterilization chamber;
-- Door(s) and its sealing system;
-- Outer cabinet (with attached technical compartment);
-- Electrical installation;
-- Hydropneumatic plant;
-- Circulation pump
-- Electronic process controller
-- Additional components (optional); -- Accessories for product loading/unloading and storage.
Accessories for loading/unloading and storage of the product.
PROCESSABLE MATERIALS :
Closed glass vials containing aqueous solutions; 2.
2. Closed glass vials containing aqueous solutions; 3.
3. Closed glass bottles containing aqueous solutions.
4. Culture soils in glass bottles with screw-tight seals
5. Closed plastic containers containing solutions
6. Closed plastic vials containing aqueous solutions
7. Closed plastic vials containing aqueous solutions
8. Closed plastic bottles containing aqueous solutions
9. Vials--glass or plastic syringes containing aqueous solutions.
POP 1 FFS 3000 Filling Machine
BRAM-COR POP2 (specific for bags with tubes) and POP1 (specific for bags with connectors) machines use PVC-Free films and are designed to produce bags for injectable solutions, in sizes from 50 ml up to 5000 ml. They actually transform a PVC-free film into a finished, filled, sealed and printed infusion bag.
The POP 1 FFS 3000 forming/filling machine is designed and manufactured with materials in accordance with CGMP and FDA standards, meeting the specifications outlined in current pharmaceutical regulations;
- All welds were performed using TIG technology
- All seals installed on the filling unit are made of soft sanitary grade TEFLON
Discharge of the bags onto the conveyor belts
The bags continue their travel until they stop (in groups of 4) in front of a second slide, which, by means of a pneumatically controlled movement, ejects them from their housing on the evacuation porter
In case one or more bags escape the ejection system, a mechanical extractor, in the return phase of the evacuation porters, intervenes on their forced extraction
Bag drying tunnel:
This station picks up the freshly filled bags, provides for their drying, and takes them to a series of conveyor belts that, in turn, direct the bags to the various storage stages.
When the operation of heating and cousing the connectors is finished, the “R” resistors move back upward, allowing the 2 “MC” vices to weld the still superheated connector spout
Coolant is passed inside the 2 vices, which, in addition to preventing the connector beak from sticking to the vices, allows the immediate solidification of the beak itself
Pouch connector soldering:
Before starting this operation, the bags are emptied of residual air by pneumatically pushing the “BS1” bar
The “BS1” bar is kept under pressure on the bags while a series of “R” resistors descend toward the connector beaks suitably clamped by the corresponding pneumatic clamps “M”
Bag pickup from the forming machine:
The bags arrive at the pick-up station (arrow 1 in the figure) and here, in groups of 4, they are pulled off the relevant advancing flights by means of an extractor “A” (arrow 2 in the figure) that provides for their subsequent engagement on a second set of flights “B”
Vibrating tank feeding:
Connectors are manually loaded inside the two vibrating tanks “V” and “V1” that feed the loading unit “B”
Connector placement:
V1
Each individual connector is brought to the vicinity of the pick-up sled which provides for the input and positioning of 4 connectors at a time, 2 coming from vibrating tank “V” and 2 from “V1”
Automatic loading of connectors an:
This station allows the automatic loading of connectors onto the feed carriers, the only operation that the operator has to perform manually is to continuously restore the correct level of bulk connectors inside the 2 feed vibrators positioned at the sides of the loading station itself.
Empty bag pickup:
PHARMACEUTICAL EQUIPEMENT
At this point, the bags continue their journey to the “BL” picking station (see figure below) from where they are subsequently transferred to the filling machine
Bag cutting and separation:
The step-by-step advance of the “PG2” gripper brings the film with the bags still joined under the “BCU” cutter
Formed bag cooling:
Coming out of forming, the now formed bag “B” goes under the cooling press “BC”.
During this stage 2 pneumatically controlled “CP” cooling molds compress the 2 films “P” by cooling them together with the corresponding connector “C”
Bag forming:
The 2 films “P” and connector “C” are brought, by the stepping feed unit, to the forming press “BF”.
During this stage 2 heated “HP” molds, pneumatically controlled, compress the 2 films “P” by welding them together with the corresponding connector “C”
Voltages: Main: 380V 50Hz Auxiliary 24V DC Powers Main 35Kw Prod: 2000 S/H
The BRAM-COR product range also includes a complete selection of Mod. STOC tanks/vessels for both pharmaceutical PW-HPW) and process water collection. Traceability, material and component certification are values of all BRAM-COR installations Strict welding and sanitary piping control procedures are applied in the production of the vessels, with non-destructive testing and in accordance with international standards for pharmaceutical equipment. Basic feature of all BRAM-COR tanks is that they are completely washable. In addition: Surfaces and components in contact with the products are certified in mirror polished AISI 316L stainless steel (Ra ≤ 0.4 µm) “Tank in Tank” construction Vertical design
Sold together with the water pre-treatment that comes with the code (24-1471)
Tank Capacity 3649 Liters Max working pressure ATM Max Working temperature tank 35 C°. Material AISI 316L
The BRAM-COR product range also includes a complete selection of Mod. STOC tanks/vessels for both pharmaceutical PW-HPW) and process water collection. Traceability, material and component certification are values of all BRAM-COR installations Strict welding and sanitary piping control procedures are applied in the production of the vessels, with non-destructive testing and in accordance with international standards for pharmaceutical equipment. Basic feature of all BRAM-COR tanks is that they are completely washable.
In addition:
Surfaces and components in contact with the products are certified in mirror polished AISI 316L stainless steel (Ra ≤ 0.4 µm).
Tank in Tank” construction Vertical design
Tank capacity 10495 Liters Max working pressure ATM Max working temperature of tank 40 C°. Material AISI 316L
This is a facility designed for the preparation of infusion solutions consisting of a room containing 4 tanks fed by the produced water and equipped with systems for the recirculation and mixing of the solutions. The plant is fully computerized and managed by an electronic control system. The produced solutions are introduced through a “solution transfer line” into the plant for the filling of the bags.
INFUSION SOLUTIONS PRODUCTION PLANT
- This is a facility designed for the preparation of infusion solutions consisting of a room containing 4 tanks fed by the water produced and equipped with systems for the recirculation and mixing of the solutions. The plant is fully computerised and managed by an electronic control system. The produced solutions are introduced through a ‘solution transfer line’ into the plant for the filling of the bags.
- 2.000 litre reactor
- Manufacturer: BRAM- COR
- Model: DISS WSCP 2000
- Testing body: BUREAU VERITAS
- Factory No.: 1312
- Year: 2002
- Weight: 1100kg
- Capacity: 2328 litres (body side) 189 litres (jacket side)
- Maximum operating pressure: 3 bar (body side) 1bsr (jacket side)
- Maximum operating temperature: 143 °C (body side)
- Weight: 1100kg - Capacity: 2328 liters (body side) 189 liters (jacket side) - Maximum operating pressure: 3 bar (body side) 1bsr (jacket side) - Maximum operating temperature: 143 °C (body side) 121 °C (jacket side) - Hydraulic test pressure: 5bar (body side) 1.7 bar (liner side)
IMA Zanasi 40F automatic capsule filling machine from 2012, with spare parts
Capacity 40000 u/h
Capsule sizes 00,0,1
Length x width x height mm 1100 × 920 × 1880
Weight 1000 kg
Via XXV Aprile, 8
21054 Fagnano Olona (VA)
Italia
Tel. +39 0331 1693557
email: inti@intisrl.it