Contained Handling Technology
IBC Systems for the Pharma Industry
IBC systems are widely used in pharmaceutical manufacturing as storage, transport and, with the increasing use of in-container applications, blending vessels.
More Than a Container
With technologies including the Blending Prism, the Vibroflow® discharge device, the world-leading BUCK® Valve and a deceleration device, common issues such as handling difficult to blend materials, poor flowing product and potent materials can all be met and addressed. The GEA IBC is designed specifically for the pharmaceutical and healthcare industries. With product contact parts constructed from 316L stainless steel, a range of finishes is available for both the internal and external surfaces. Modern construction techniques ensure accurate manufacturing tolerances are met with repeatable dimensional accuracy.
Blending Prism™
The GEA Prism has been developed to aid and improve the blending of difficult-to-process powdered and granular materials.
Vibroflow®
The unique Vibroflow® discharges even the most poorly flowing products. Vibration is applied from the discharge station to the discharger located in the container. Powder is prevented from bridging as vibration is applied at the key area where powder bridging occurs. Product flows at a constant speed, effectively removing the risk of segregation.
Containment Valves
An important feature of the GEA IBC is the High Containment Split Butterfly Valve. The BUCK® MC Valve offers improved containment levels for a variety of applications. The valves can be fitted to the IBC inlet for contained charging, or an invertible design allows charging through the outlet valve.
Deceleration Device
Specialized solids deceleration devices have been developed for improved solid discharge control, enabling smooth, dust-free transfer. They are available for drop distances of 1.5–3.5 m and use a fully automatic, interlocked control system. An optional proportional controller for the pinch roll opening allows for variable discharge rates.
Clean-in-Place
An important feature of any containment system is preventing operator intervention. All GEA IBCs are designed to be CIP-compatible with our Wash Station. The passive valves are mounted on the inlet and outlet of the IBC in a manner that prevents any dust ingress. Naturally, both the Prism and the Vibroflow® have been designed to accommodate full CIP solutions.
| Size 1 | Size 2 | Size 3 | Size 4 | Size 5 | |
| Footprint | 525 x 620 mm | 725 x 840 mm | 960 x 1125 mm | 1125 x 1325 mm | 1350 x 1590 mm |
| Max Volume | 150 L | 300 L | 600 L | 2000 L | 3000 L |
| Min Volume | 75 L | 200 L | 400 L | 700 L | 1200 L |
| Min Volume Bottle
in a frame | 25 L | 50 L | 50 L | 100 L | 100 L |
| Size 1 | Size 2 | Size 3 | Size 4 | Size 5 | |
| Product contact area | BS EN 10088-2 1.4404 (AISI 316L) Stainless Steel | ||||
| Non-product contact area | BS EN 10088-2 1.4301 (AISI 304) Stainless Steel | ||||
| Seals and gasket | FDA approved EPDM/ Silicone | ||||
| Size 1 | Size 2 | Size 3 | Size 4 | Size 5 | |
| Manway size | 300 mm | 300/460 mm | 300/460 mm | 300/460 mm | 300/460 mm |
| Spun lid with clamp band
and seal | ● | ● | ● | ● | ● |
| Bolted plate lid with
hygienic seal for mounting BUCK® Valves | ○ | ○ | ○ | ○ | ○ |
| Clamped plate lid with
hygienic seal for mounting BUCK® Valves | ○ | ○ | ○ | ○ | ○ |
● standard ○ optional -- not available
| Size 1 | Size | Size 3 | Size 4 | Size 5 | |
| Pallet guides | ● | ● | ● | ● | ● |
| Stacking/blending clamping features | ○ | ○ | ○ | ○ | ○ |
| Post hoist pick-up features | ● | ● | ● | ● | ● |
| Skid feet for conveyor handling | -- | -- | ○ | ○ | ○ |
| Invertable design | ○ | ○ | ○ | ○ | -- |
| Size 1 | Size 2 | Size 3 | Size 4 | Size 5 | |
| "Natural 2B cold rolled finish (<0.5µm Ra), welds ground back to parent metal and strip polished to a 0.5µm Ra or better finish" | ● | ● | ● | ● | ● |
| "Mirror 2P finish (<0.1µm Ra), welds ground back to parent metal and striop polished to a 0.2µm Ra or better finish" | ○ | ○ | ○ | ○ | ○ |
| As above, and electropolished | ○ | ○ | ○ | ○ | ○ |
| Size 1 | Size 2 | Size 3 | Size 4 | Size 5 | |
| "Natural 2B cold rolled finish (<0.5µm Ra), welds as laid, chemically cleaned and strip polished" | ● | ● | ● | ● | ● |
| "Satin brush finish (<1.0µm Ra, welds chemically cleaned and polished" | ○ | ○ | ○ | ○ | ○ |
| "Satin brush finish (<1.0µm Ra, welds ground back to parent metal, chemically cleaned and polished" | ○ | ○ | ○ | ○ | ○ |
● standard ○ optional -- not available
Charge & Discharge
For poorly flowing materials, products that are subject to segregation and damage, and the need to transfer potent products in a contained manner, we provide unique technologies for accurate IBC filling and discharging. These ensure high levels of containment, rapid product changeover and segregation-free discharge.
Deceleration Technology
The decelerator enables products to be fed at a controlled low velocity, therefore eliminating the segregation of powder or granular materials. Tablet or capsule 'outfeed' systems benefit from reduced breakage, chipping or mechanical damage, resulting in increased production performance and reduced product rejects.
Segregation can occur during IBC discharge if a product 'rat-holes.' It can also take place post-discharge when product is allowed to fall through long chutes in free fall and displaced air from below is forced back up the chute and separates the finer particles from the coarser particles.
The Air Deceleration Unit consists of a stainless steel chute that transfers material from the discharge station to the inlet of the rotary tablet press or capsule filler. A flexible, inflatable silicone membrane through which a flexible polythene product liner runs internally through the length of the chute, is inflated and/or deflated to control the rate of material descent.
Vibroflow® Discharge Technology
A critical aspect of any IBC system is its ability to discharge product in a reliable and repeatable manner. It is no longer acceptable for operators to intervene and open the IBC to overcome blockages.
The unique Vibroflow® was designed to meet these needs and, having been thoroughly tested by leading pharmaceutical manufacturers, is now a proven discharge technology.
The Vibroflow® is mounted in an IBC between the outlet flange and the Half Valve. By applying a low frequency vibration to the centre of the product bed, "bridging" can be prevented. The spiral design sends vibrations sideways through the product bed, promoting mass flow. The vibration is applied externally from the valve, so there are no working mechanisms within the process flow.
Another Vibroflow® benefit is its ability to overcome vacuum build up, which can be an issue for larger volume IBCs. The Vibroflow® allows air to percolate through the powder bed and into the top section of the IBC, removing the need to vent the IBC, which compromises the containment of the IBC.
Containment Valve Technology
GEA has become synonymous with supplying high containment systems incorporating advanced split butterfly valve technology. Our charging and discharging stations use a patented docking system that uses two Half Valves.
One Half Valve is located on the outlet/ inlet of the IBC, while the other Half Valve is connected to the process machine. This unique design with a centralized actuation collar facilitates the simple operation of the containment valve system.
With the IBC loaded onto either the discharge or charging station, the two identical Half Valves dock. The two external faces of the valves are sealed together to prevent dust contaminating the surfaces. Joint turning allows powder to pass through the valve without the disc faces contacting the product.
Containment for Reducing Operator Exposure Level (OEL)
Our discharging and charging stations can further reduce Operator Exposure Levels (OELs) with the addition of an advanced air cleaning actuator (BUCK® Valve UMC).
Dispense & Weigh
The transfer of powders and/or tablets to and from an IBC can often be a complex operation and is an area in which GEA has become a market leader.
Accurate Dosing System
Multi position control of the butterfly valve, linked into an integrated load cell system, allows highly accurate IBC charging and discharging. Proportional opening and closing pf the valve accurately controls the product flow rate.
The weight of the IBC is fed back to the control system and, as the required weight is reached, the system gradually closes the valve to reduce material flow.
Once the required weight has been reached, the valve is closed. GEA's dosing systems are of particular benefit during the dispensing stage of the drug manufacturing process, when raw materials need to be accurately dosed into IBCs for recipe and batch formulation.
Dispensary System
A dispensary can take many forms: single or multi level, low or high containment levels, commonly incorporating two to four weigh platforms, a weigh hopper, extraction equipment and sieving equipment. The dispensary may also include recipe management software, waste disposal system and a method of handling API.
Excipients and bulk ingredients arrive packaged in various forms, thus requiring differing handling methods. For small volume dispensaries or line dedicated dispensaries with a small batch size, the preferred method may be manual. However, with ever more stringent manual handling regulations, it may be necessary to add automation and mechanical handling to avoid these problems.
For larger volume plants and larger batch sizes, it is essential to automate the handling. This is achieved by either simply lifting a pallet with a local stacker truck, or ideally by using a hoist lifter. The advantage of the hoist lifter is its ability to simply handle sacks, drums and bags without the additional difficulties of maneuvering in what is often a confined area.
The GEA range of modular dispensing solutions provide for simple ergonomic operation whilst ensuring control of the dispensing process.
The control system interlocks the process with the recipe management system to provide batch data security and traceability for validation purposes. Additional features such as removable hoppers and additional extraction provide increased safety for operators and simplicity for cleaning. Solutions range from single level for simple applications to multiple level, integrated dispensary management systems. Bulk ingredient dispensing includes fully automated excipient dosing or interfacing with big-bag bulk ingredients for high containment.
APIs (active pharmaceutical ingredients) can be dispensed into a contained charge vessel, which can then be safely transported to the point of use within the plant.
GEA will normally supply a dispensary system as an integrated package with the specification and design incorporating key issues such as: interchangeable weigh hoppers, batch data security and traceability, ease of maintenance, cleanability, building and utility requirements, and all process requirements.
Wash
As cleanliness is paramount in pharmaceutical manufacturing, an important feature of any IBC system is the ability to wash containers to a consistent, repeatable standard, both externally and internally. An extensive selection of washing systems has been created to suit the diverse needs of the market — and to minimize production downtime — ranging from simple internal wash systems to fully automatic washing, drying and cooling booths.
Your Washing Solution
It is critical to establish an appropriate cleaning philosophy for any new facility. Depending on the products, processes and production demands, cleaning should be thought of as an integrated part of the materials handling system and not looked at in isolation.
A multi-product plant may require quick changeovers, whereas product-dedicated plants might adopt a clean-in-place (CIP) approach. When handling hazardous or toxic materials, CIP may be the preferred option, particularly if it can be combined with a contained rapid changeover solution.
GEA supplies simple-yet-contained wash systems that ensure operator safety during cleaning. We also provide wash solution preparation systems and process control solutions to allow full validation of the washing system. Our range includes
• mobile CIP/WIP units
• clean-off-line designs
• Moduwash container washing systems
• automated container washing systems
• IBC Halo washing technology.
BUCK® Valve Washing
Although it is important to handle and transfer powders in a contained way to prevent operator exposure, it is of equal important to be able to wash the IBC and the containment valves in place without the need for operator intervention to strip and clean the valve. Any system that relies on the operator to remove a contaminated valve for cleaning will directly expose the operator to the product. All IBCs and their passive valves are designed to be fully cleaned-in-place within the GEA Wash Station. CIP of the BUCK® Half Valve is achieved using the BUCK® Wash Active System.
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Produtos relacionados
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