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Glossary

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
See palletizer.

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 transfered 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.

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