High purity systems from LEWA for use in the pharmaceutical and biotechnology industries

Exact metering, ability to be sterilized and above all precision and repeatability are central in the process criteria in the pharmaceutical & biotechnology industries. Pumps operate reproducible even at high pressure, and offer an economical solution for homogenization processes

LEWA high purity systems with integrated process pumps are designed for hygienic processes in high pressure areas. LEWA triplex process pumps are characterized by their durability and low maintenance costs.

LEWAs expertise for homogenization with high purity systems

Advantages of LEWA high‐purity systems, which are developed according to customers’ requirements for demanding applications in the biotechnical and pharmaceutical industry:

  • LEWA triplex process pumps with hygienic diaphragm pump head M900 are approved solutions to realize discontinuous (batch mode), semi‐continuous or continuous homogenization processes aseptically.
  • CIP/SIP capable process diaphragm pumps for metering challenging sterile products (e.g. functional food, neutraceuticals, parenteral nutrition and pharma products)
  • Metallically sealed ball valves
  • Wetted parts in stainless steal
  • System complies with all regulatory standards (cGMP, GAMP, 21 CFR etc.)
  • Solutions for high pressure ranges: Pressures up to 1,200 bar which are needed to realize cleanroom productions down to the nanometer range (e.g. liposomes, nanoparticles, micronizates, intravenous emulsions, vaccines etc.)
  • Hygienically designed interfaces to connected piping and other components are also suited for high pressure ranges.
  • Easy cleaning according to approved industry standards (EHEDG, OHD, FDA‐ and USP Class VI)

Background

What happens at homogenizing processes?

By homogenizing, different fluids, which are normally not soluble in each other, are dissolved to a homogeneous, single phase solution. To succeed in this process, the droplet size in the fluid has to be minimized to a small and constant diameter. This happens by using high pressure on the liquids. The substance passes through a high pressure pump, is compressed, and afterwards stress‐relieved by a homogenizing valve. In this way, solutions with the desired properties are formed.

For the pharma and biotech industry, homogenization is very important, because even the smallest quantities of a medication have to contain the same amount of the active pharmaceutical ingredient. By homogenizing a fluid, an absolute consistent blending can be achieved.

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