DQ Design Qualification
Based on the Design Qualification documentation, tests are carried out to ensure that the final design of the system conforms to customer specifications. Deviations are eliminated and further follow-up actions stipulated.
FAT Factory Acceptance Test
Acceptance test carried out in the supplier factory with the collaboration of the customer. Otherwise known as the preliminary acceptance/delivery permit.
KLT
Plastic transport container for the transport of workpieces/products.
FDA (Food and Drug Administration)
US government approval and licensing agency for food and drugs. The FDA control the safety and effectiveness of human and animal drugs, food, biological products, medical products and radiation-emitting devices.
GAMP guidelines (Good Automated Manufacturing Practice)
The GAMP guidelines, now in their fourth edition since the end of 2001, are the rules and regulations standard for the validation of automated systems in the pharmaceutical industry.
IQ Installation Qualification
Documented proof that a system has been installed in accordance with written and approved specifications.
Load Carrier
In the area of logistics, load carriers refer to carriers for the purpose of transport or the protection of goods.
They serve to facilitate transport while at the same time protecting goods from external influences. The term can refer to either standardized or customized transport devices. Typical examples of load carriers in the area of logistics are Euro pallets.
In the area of controlled material provision, plastic trays,
blisters, KLT boxes, etc. are generally used for goods.
OQ Operational Qualification
Documented proof that a system has been installed in accordance with written and approved specifications.
Pallet
Pallets are flat constructions, generally made of wood, that are used to transport certain stackable goods. The most common pallets are Euro pallets (1,200 x 800 mm), industrial pallets (1,200 x 1,000 mm) and ISO pallets or customized pallets with special dimensions and add-ons.
Palletizing
After the actual manufacturing / production, the goods are packaged to protect them later for further action in the subsequent supply chain to external influences.
Mostly it is a two-stage packaging process: The primary packaging and secondary packaging.
The primary packaging is in direct contact with the product and is often used for reasons of hygiene. At her count packages such as pouches, blisters, cans, jars, bottles etc.
The secondary packaging is a simpler and optimized charge education for the subsequent final packaging. The most common type of packaging in this area is probably the corrugated cardboard. With it the individual, packaged in primary packaging products are grouped into units of charge. Boxes can be stacked easily and position stable charge-units. On the other hand, they protect the secondary packaging to external influences such as dirt, destruction, etc.
After the packaging process the formed load units are transpotated by conveyor belts to the final packaging. There they are then grouped to carriers, to prepare them for the transport of the company to the customer. As carriers are often used wooden or plastic pallets in the packaging sector.
After specially calculated position patterns or location schemes, the pallets are then loaded with the cargo units. This is to be produced for reasons of stability as possible a layer composite. Often heavy weights need to be handled, which is associated downtime for manual activity to serious people diseases and associated. Lately, therefore more and more machines are used for these tasks.
With innovative gantry systems such as EURO-Line or Portal.Line palletizing can be automated in an economical and humane way in the companys.
Palletizing = categorizing, out, buffer …
During the assembly and production of components or products at the beginning there are often processes like loading and sorting. Many items for the assembly process must be fed sporadically and assembly machines. These are often in the small parts to so-called bulk material, which is delivered in appropriate carriers such as boxes or sacks and isolated over conventional spiral conveyor with mechanical chicanes and is supplied to the production process.
But in many cases the parts can not be easily provided with this method to the production.
Electronic components, for example require a careful and meticulous handling before they are mounted in the production process. Plastic parts with sensitive surfaces are not allowed to have any scratches or other defects characteristics.
These parts are therefore in the logistics chain of the company standing in a so-called parent material flow. They are, for example, transportated in carriers such as plastic thermoforming trays, boxes or small charge blisters carriers. The separation out of these charge carriers is called also palletizing or categorizing. Unlike the palletizing for final here is not moving large loads in the foreground, but rather the quick and accurate handling of different types of charge carriers. The palletizing systems are therefore hereby as provisioning systems to use a once established order in the production and after transport elsewhere again targeted supply the data stored in the special carriers parts production.
But these palletizing can far more than the separation of these charge carriers. The palletising system SPEED-Line is equipped with a high-precision handling systems (NC servo axes) and can in addition to the separation of the charge carriers refer to the parts of the charge carriers and passed to the manufacturing facility or, connected to a production facility workpiece carrier circulation system. And with an accuracy of 5/100 mm up to 3,000 parts minute.
Of course, as the palletizer SPEED Line can not only be used for the provision, but also for the packaging of products in the carriers.
Connected between two production lines, palletizing systems can also serve as buffers. If the production process is to be interrupted on a machine, the palletizer buffers the parts until the fault is rectified. Connecting it gives again the parts in the process free and the production can continue.
Palletizer/palletizing system
Palletizers or palletizing systems refer to automatic packaging devices or loading equipment.
Palletizers can be used for the stacking or packaging of products or components onto/into load carriers.
Another area where palletizers are often used is for the transfer of products or components from load carriers to follow-up production and/or assembly lines.
In such cases, the load carriers are transferred to the system either manually or using suitable feeding technology.
PQ Performance Qualification
Documented proof that the system is able to execute and/or control the processes in its assigned system environment for which it is intended in accordance with written and approved specifications.
SAT Site Acceptance Test
Acceptance test in the customer premises.
Ultrasonic welding
Ultrasonic welding is largely used to join/assemble plastics. At the welding seams, the material is melted through the application of heat. This is generated by means of high-frequency mechanical oscillations.
The oscillations are achieved using a generator. This converts mains electricity into a high voltage and high frequency. The electrical energy is transfered to an ultrasonic transducer, the converter. The converter uses the piezo-electric effect to utilize the properties of certain crystals, which expand and contract when an alternating electric field is applied. This creates mechanical oscillations that are transfered to the sonotrode.
Under force, these oscillations are transfered to the workpiece. This locally applied heat causes the plastic to melt.
A key feature of this process is the extremely short welding time, which generally means it is very cost-effective.
Validation
Documented proof that there is an extremely high probability that a specific process is able to permanently deliver a high-quality product that complies with the given specifications.
Workpiece carrier
A workpiece carrier is a receptacle for a workpiece or component to be processed by assembly and handling technology.
A workpiece carrier is able to accommodate one or more workpieces. These are then advanced along a production line through a variety of production stations.
The workpiece carriers containing the components are positioned and fixed in the individual processing stations. The machining process, which is usually automated, can then be executed.
The term workpiece carrier covers an extremely broad spectrum of devices, ranging from simple pallets that are advanced over belt or chain conveyors, through to workpiece carriers that are self-powered and fitted with information systems.