Services

EbeTech supports its customers from the project start up to the production start and beyond. Special know-How, especially in the pharmaceutical industries, enables EbeTech to support the customer at the maximum level. After-Sales Service we consider as one of the key issues.

 

 

Engineering

Complete customized Engineering for all equipment and interfaces to be supplied. Perfectly designed layout drawings as well as P&ID diagrams are the basis for a successful project. EbeTech offers from the basic design up to the detail deign all engineering steps.

 
   
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Validation Support

The validation support consists of identifying and testing all aspects of a process that could affect the final test or product. Prior to the testing of a process, the system must be properly qualified. Qualification includes the following steps: (These steps are common practice for equipment IQ, OQ and PQ).

Design qualification (DQ)

Defines the functional and operational specification of the instrument, program, or equipment and details the rationale for choosing the supplier.

Installation qualification (IQ)

Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.

Operational qualification (OQ)

Demonstrates that all facets of the process or equipment are operating correctly.

Performance qualification (PQ)

Demonstrates that the process or equipment performs as intended in a consistent manner over time

Component qualification (CQ)

is a relatively new term developed in 2005. This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

There is often overlap between Installation, Operational, and Performance Qualification and sometimes these are performed simultaneously. This combined testing of OQ and PQ phases is sanctioned by the European Commission Enterprise Directorate-General within "Annex 15 to the EU Guide to Good Manufacturing Practice guide" (2001, p. 6) which states that:

"Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ."

 
   
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After-Sales-Support

Special know-how is required to install complex production lines and to take them into service. Trained staff has usually participated in the construction of the machines to be taken into service and so have the intimate knowledge required to install them professionally and without delay at the customer's facility. Technicians with practical experience in mechanical, electrical and electronic aspects ensure that production can start as soon as they have finished their work and trained the staff at site. As with any vehicle, care and maintenance are prerequisites for a reliable and long-lasting service life. The user can carry out most of the required measures himself in following the supplied schedules and instructions.

 
   
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