USP VI approved Pharmaceutical series pumps
We are proud to introduce our brand new USP approved (United States Pharmacopoeia) hygienic PE pump. The Pharmaceutical series is developed in co-operation with one of the world leading supplier to the biotech market. It is produced to serve the biotech- and pharmaceutical industries in numerous applications.
The pump range:
TU53 (3/4") – 60 l/min
TU103 (1") - 125 l/min
THU203 (1 1/2") - 330 l/min
THU403 (2") – 570 l/min
Features & benefits
Smooth internal surfaces
no bacteria growth
Inert and clinical tested materials
no contamination of the pumped product
Pump housing with very few components
extremely easy to maintain
Sanitary clamp connections
easy connection to standardized pipework
Wetted components made from USP VI approved materials
no contamination of the pumped product and no bacteria growth
USP VI approved materials (OPTION)
U.S. Pharmacopeial Convention (USP) class I to VI defines how a plastic or rubber material may be exposed of human tissue. Class VI requires the most stringent testing and such materials may be used for example in implant devices.
EHEDG certified products
The EHEDG (European Hygienic Engineering & Design Group) certificate proves that the design is according to the hygienic guidelines. Furthermore certified products are clean ability tested.
FDA §21 CFR 177 materials
FDA (U.S. Food and Drug Administration) §21 CFR 177 lists polymers, e.g. rubber and plastic materials approved for equipment in contact with food products.
EN 10204 material traceability
The EN 10204 norm gives you a checklist and traceability of materials used in the equipment. 2.1 is a general statement of compliance with material specifications, while 3.1 provides specific track records all the way to the steel mill batch (normally only on metals in contact with the product).
EC 1935/2004 regulation
This EU regulation applies to all food contact materials, e.g. metals, plastics and rubber materials. It requires that these materials are safe, are labeled with the glass-and-fork symbol, are traceable throughout the production chain (according to above EN 10204) and that they are produced according to good manufacturing practice (GMP).
A product classified as machinery that carries the CE mark fulfill the essential health and safety requirements of the EC Machinery Directive 2006/42/EEC.
ATEX Directive 94/9/EC
Equipment intended and approved for safe operation in potentially explosive atmospheres. The equipment is divided in main groups, categories, apparatus groups and temperature classes to define its suitability in the actual zone.