Pharmaceutical production with LEWA metering systems

The pharmaceutical industry has very strict requirements for their manufacturing processes. Metering pumps and metering systems must meet these demands. LEWA metering systems support to run continous and safe production processes.

Solution

With the ecodos and ecoflow pump series in sanitary or hygienic design as well as the LEWA-developed mechatronically controlled intellidrive drive technology, LEWA offers pumps that meet the high demands of pharmaceutical production without limitations:

  • High metering accuracy
  • Precise reproducibility for continuous processes
  • Wide metering range
  • Suitable for a wide variety of fluids
  • Hermetically tight process chamber to save product and environment
  • Short product holdup times and gentle conveying
  • Depending on the option: CIP and SIP cleanability
  • Hygienic and pharmaceutical designs
  • FDA-compliant materials
  • 3.1-material certificate
  • EHEDG test certificate, QHD certificate
  • Compliant with clean room requirements

LEWA metering systems excel primarily due to their fast, high-precision flow control.

Not only a mutual monitoring of pumps and flowmeters results from the pump characteristics stored in the process control, but also a plausibility check. This ensures high operating reliability and metering accuracy.

A further advantage is that the entire production process can be logged with no omissions, to pharmaceutical specifications. LEWA offers a large degree of practical experience during the selection of the suitable flowmeter and other components: All components match with each other and thus ensure a perfect function of the metering system.

Background

Process description

Fluids must be added to a substance mixture in pharmaceutical processes. This can also mean that the system must first prepare the product to be conveyed (e.g., blending, melting of salts, temperature control, dispersing, etc.). A custom-designed solution for the functionality of the system and adjustment of the individual components to the overall system is therefore required.

The actual conveying of the fluid must then be done under defined process conditions, e.g., definition of pressure and temperature, placing high demands on process control and thus on the complete system solution.

A stable process is possible with coordinated and individually programmed instrumentation and control technology and a control system. Using storable recipes in this system control, processes are carried out reliably and with maximum repeatability. Logging of the process progress and its results is indispensable for a reliable production in order to fullfil cGMP requirements.

The different user levels are only accessible to approved users. The system must have a design concept so that these can be qualified and validated. Therefored the guidelines according to CFR 21 part 11 are fulfilled.

The product made with the system must correspond to the specified quality guidelines of the pharmaceutical industry and conformity must be able to be verified at anytime.

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