Manufacturing Equipment

Qualification of Manufacturing Equipment

The proper operation of the manufacturing equipment is critical for the assurance of product quality and process stability.

The GMP requirements stipulate that the manufacturing process must be performed on qualified equipment before it can be validated. The qualification of manufacturing equipment is understood as ensuring that the manufacturing equipment and supporting systems are capable of continuous and stable operation within the specified limits and tolerance.

We perform the qualification of manufacturing equipment with regard to:

Manufacturing equipment (capsule filling machines, tablet presses, mixers, granulators, fluidising towers, reactors, driers, scales, etc.)

Packaging machines (tube filling machines, bottling machines, blister packaging machines, carton packaging machines, labelling machines, OCR and OCV, etc.)

Accessories
(mills, pumps, conveyors, printers, etc.)

Complete production lines

Sample Project

Preparation of a complete qualification
of a dry form packaging line

Scope

The project consisted in the preparation of a complete validation of a dry form packaging line with controlled humidity of ≤20% rH, consisting of a thermo-forming blister packaging machine, carton packaging machine, overwrapper (bundler) and palletiser.

The validation consisted of 3 stages and included:

  • qualification of the installation of machinery and of the controlled humidity maintenance installation,
  • operational qualification, also covering connected computerised monitoring systems, control and data storage systems according to the data integrity management recommendations of the FDA,
  • performance qualification by means of a series of tests verifying if each component of the packaging line meets the expected performance requirements and the selection of the most appropriate parameters for the validation of the packaging process.

Results of implementation

In spite of the complexity of the project due to the necessity to ensure controlled humidity and meet tight deadlines, the production line was commissioned on time.

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