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Pharmaceutical industry
and biotechnology:
sterility in all processes
In the pharmaceutical and the biochemical industries, the specification profiles of pumps are subject to a wide range of international laws, regulations and directives. These include the EU Machinery Directives, relevant standards such as DIN EN 12462 Biotechnology, the GMP regulations, US standards such as 3A, and ensuring FDA (Food and Drug Administration) compliance in the use of materials. The greatest possible biological safety must be ensured for the manufacturing process as a whole, and certified cleanability (CIP), for which pumps must be designed without dead spaces or crevices, plays a key part in this. Other important parameters include assured sterilisation (SIP) or sanitisation, and certification concerning the use and origin of materials (3.1 B certificate, FDA compliance). Documented surface finish and ferrite content as well as extensive welding documentation form part of the standard scope of delivery for such pumps.
In order to satisfy these requirements, Hilge offers singlestage and multistage pumps in horizontal or self-draining vertical position, endsuction and self-priming in Qualified Hygienic Design. In order to ensure safety in sterile process control, Hilge only uses low-carbon materials with material quality 316 L (1.4404 or 1.4435) as pore-free rolled or forged stainless steel (no stainless steel investment cast ings). Depending on the requirement, pumps are available in various sterile standards with surface finishes of ≤ 0.8 µm Ra to ≤ 0.4 µm Ra, with an optional d-ferrite content of ≤ 3% or ≤ 1%. For special requirements in the pharmaceutical industry, Hilge also supplies the single-stage and multi-stage Contra series in highly corrosion-resistant Hastelloy C, from forged material. The documentation delivered with them in accordance with customer requirements provides the basis for qualification of the components supplied and subsequent validation of the complete facility. Here again, Hilge shows itself to be a competent, reliable partner.
The pump ranges that we recommend for use on pharma and biotec applications are marked with the appropriate symbol in our catalogue. To open our product catalogue click here.
