Full FDA compliance of Certa 250 pump enables US exports for leading UK natural healthcare manufacturer
Key points
- MasoSine Certa 250 pump from Watson-Marlow Fluid Technology Group helps natural healthcare manufacturer export products to the US
- Ease of cleaning and aseptic certification prevent contamination issues and satisfy FDA requirements
One of the UK’s leading natural healthcare manufacturers, has integrated the MasoSine Certa 250 pump by Watson-Marlow Fluid Technology Group (WMFTG) into its pharmaceutical creams manufacturing process.
The pump satisfies all FDA requirements, with full clean-in-place (CIP) capabilities, successfully enabling the Company to export its natural healthcare products to the US and expand their global presence.
Exporting to the US
The Company wanted to export its products to the US to expand its global reach. In order to do so, the Company needed to meet all FDA manufacturing regulations and provide the necessary certification for all aspects of its manufacturing process.
The pharmaceutical creams processing presented a problem for FDA compliance as the pump previously deployed was difficult to clean and did not offer appropriate certification.
The process required a pump which provided both clean-in-place (CIP) capabilities and the ability to transfer creams slowly to prevent air ingress and shear.
Certification provides confidence
The MasoSine Certa 250 was selected as it both complies with FDA requirements and provides all the required pump functionality. With EHEDG Type EL Class I as well as EHEDG Type EL Aseptic Class I and 3A certification, the pump provides fully accredited CIP capability, satisfying FDA requirements and the natural healthcare manufacturer to target the US market.
Head of Operations at the natural healthcare manufacturer, commented: “As the pump doubles as a high-volume CIP pump, we can now clean the pump and associated hoses with ease. The Certa pump gives us the confidence we need in our manufacturing process in order to offer the highest quality natural healthcare products to US customers.”
End-to-end process expertise
In order not to disrupt production, ease of integration into the existing production line was essential. Utilising 60 years’ expertise in end-to-end fluid management across a range of industries, the MasoSine Certa 250 pump is designed to fit into any pathway with a range of available ports. This enabled its seamless integration into the pharmaceutical cream process. The pump has successfully been in use for over 18 months.
“The Certa 250 pump integrated perfectly with our existing process, enabling us to progress from conception to validation in under four weeks. Having already used a range of Watson-Marlow products, we were aware of the breadth of their offering and their experience across pharmaceutical and food manufacturing.” Added the Head of Operations at the natural healthcare manufacturer.
Watson-Marlow Fluid Technology Solutions
- 01326370370
- info@wmftg.co.uk
- https://www.wmfts.com/
- Bicklandwater Road, Falmouth Business Park, Falmouth, Cornwall, TR11 4RU GB
About us
Watson-Marlow Fluid Technology Group (WMFTG) peristaltic tube and hose pumps meet requirements including: value for money; low cost of ownership; reliability and ease of maintenance to the food and beverage, chemical, pharmaceutical, mining and many other industries.
We demonstrate how pumps deliver significant process efficiencies over the lifetime of the equipment. Whether performing flavouring addition in food processing, chemical metering in water treatment or mineral recovery, we have a solution which can cut pump downtime and reduce costs through higher accuracy metering and transfer. WMFTG has dedicated application engineers available to help customers make the right pump and tubing choice from a range providing microlitres per minute to 80 cubic metres per hour flow rates.
The only part of the pump to come into contact with the product is the tube or hose. This means there are no seals or valves that can wear or fail. Replacing the tube or hose can be performed quickly and safely. Peristaltic pump benefits include:
Total fluid containment with no seals No ancillaries Handle viscous and abrasive slurries and sludge Self-priming capability Dry running without damage to the pump In addition to their range of positive displacement pumps, Watson-Marlow Fluid Technology Group has added PTFE-lined chemical and industrial hoses to their range. Aflex hoses are reinforced to withstand the most severe conditions and use.
Where we supply to
Europe, Africa, Asia, Australia, South America, North America
Industries we supply to
Automation, Chemicals, Consultants, Components Electronics, Energy and Power, Food and Beverage, Glass Ceramics Cement, Metals and Minerals, OEM, Paper and Pulp, Pharmaceutical Cosmetics Toiletries, Plastics and Rubber, Recycling, Textiles, Tobacco, Water and Wastewater
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