Sanitary And High Purity Pumps

Sanitary And High Purity Pumps

Pumping Solutions for the Life Sciences Industry

Chisholm Corp. offers a wide variety of sanitary pumps and other products widely used in the Life Sciences sectors for general fluid transfer, filtration, separation and purification, chromatography, fermentation, buffering, circulation and mixing, dosing and many more applications.

The applications can be upstream of the process, where the cleanability of the pumps may not need to be at the ultra-sanitary level, or they can be directly involved in the process itself, requiring the highest sanitary standards available.

There are a number of different Standards required by the Life Sciences industry, depending on the application:
  • 3-A SSI formulates sanitary standards and accepted practices for the sanitary design, fabrication, installation and cleanability of dairy and food equipment or systems used to handle, process and package consumable products where a high degree of sanitation is required. These sanitary standards and accepted practices are developed through the cooperative efforts of industry experts. 3-A Sanitary Standards provide material specifications, design criteria and other necessary information for equipment types to satisfy public health concerns. 3-A Sanitary Standards are available for many equipment types, from fittings to silo tanks. The goal of 3-A SSI is to protect consumable products from contamination and to ensure that all product surfaces can be mechanically (CIP) cleaned or easily dismantled for manual cleaning.
  • 3-A Accepted Practices cover a system, which is defined as a set of connected equipment and machinery that forms a whole or works together. In addition to the criteria for equipment, a practice may also provide specifications for sanitary installation and legal controls. 3-A criteria is universally accepted by equipment manufacturers, fabricators, users and sanitarians.
  • The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
  • The European Hygienic Engineering and Design Group (EHEDG) is a consortium of equipment manufacturers, food industries, research institutes as well as public health authorities and was founded in 1989 with the aim to promote hygiene during the processing and packing of food products.
  • The principal goal of EHEDG is the promotion of safe food by improving hygienic engineering and design in all aspects of food manufacture.
  • EHEDG actively supports European legislation, which requires that handling, preparation processing and packaging of food is done hygienically using hygienic machinery and in hygienic premises (EC Directive 98/37/EC, EN 1672-2 and EN ISO 14159).
  • USP Class VI Elastomers. The United States Pharmacopeia (USP) is a private (non-governmental) organization that  “promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies.” Those standards include  in vivo animal biological reactivity tests for “ elastomerics, plastics and other polymeric material with direct or indirect patient contact.”
  • USP monograph 88 describes the classification of plastics into six classes based on responses to a series of in vivo tests of which Class VI is the most stringent, requiring animal implantation of the test material for at least 120 hours with no negative effects.

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