Certa Plus– advancing pharmaceutical fluid handling

Overview

Certa Plus brochure

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Drawing on considerable experience in sinusoidal pumping technology, Certa Plus has been developed by MasoSine to meet a broad range of applications for the pharmaceutical industry. These include:

Suppositories – Superior handling capability from high and low viscosity supports more efficient processing

Syrup and sugar solutions – Continuous pumping action improves the circulation process when thickening the final product. Seal-flush options are available to prevent sugar-based products drying out

Creams and gels – Strong suction capability moves high viscosity products from the mixing tank/reactor to the filling line with ease

Lozenge – Energy efficient pumping action even tackles high viscosity pastille products. Available jacketing option prevents the product from hardening within the pump if it’s stopped

• High suction capability to handle viscous fluids
• Low shear, zero pulsation and self-draining
• Uses up to 50% less power than lobe and circumferential piston pump types
• Easy to clean pump design certified with:
  EHEDG Type EL Class I
  EHEDG Type EL Aseptic Class I
• Exposed fluid contact materials made of stainless steel 1.4435 material with electropolished surface
• All fluid contact materials meet the latest FDA and USP Class VI requirements

Sine pump advantage	Sine® pump design   A single sinusoidal rotor creates four evenly sized chambers. As each chamber rotates it gently conveys the fluid from the inlet port to the outlet port. At the same time, the opposite chamber opens to draw in more fluid resulting in a smooth flow with virtually no pulsation. A gate stops fluid flow from the higher pressure outlet to the low pressure inlet.
Low shear and zero pulsation – ultra low shear pumping with no loss to valuable product integrity
Superior viscous handling – powerful suction up to 0.85 bar / 12 PSI vacuum. Products with viscosities from 1 cP to 8 million cP can be transferred with ease.
Simplicity – minimal downtime. One shaft, one seal and no timing gears allows maintenance through the front cover keeping the pump connected to the pipes.
Interchangeable parts –fully interchangeable components between pumps of the same size, reducing spares.

Cleaner than any lobe or circumferential piston pump

• EHEDG Type EL Class I and EHEDG Type El Aseptic Class I
• The type EL Aseptic Class I certification that Certa Plus carries applies to closed equipment, wet cleaned-in-place (CIP) without dismantling, It is steam sterilisable andbacteria tight. All components are made of FDA andUSP Class VI certified raw materials
• Removes the risk of residuals after CIP cleaning due to the unrivalled sanitary design
• Reduces the amount of cleaning chemicals used, and cuts the required cleaning cycle time to a minimum

Modular seal system options:

• Single mechanical seal
• Single mechanical seal with flush
• Double mechanical seal (which can be used with, and without an overpressure system)

Virtually pulsation free

• Smooth product flow with no need for ancillary dampeners, ensuring product quality
• Improves flow meter accuracy and heat exchanger efficiency

Lowest cost of ownership

• Extremely simple maintenance performed in-place by operative
• Patented design allows bi-directional running to pump duty fluid back to source
• Certa Plus can be included in aseptic processes without the need of additional steam ports due to bacteria tight design proven by EHEDG Type EL Aseptic Class I

Energy efficiency

• Requires up to 50% less power than lobe or circumferential piston pumps
• Greatly reduced electricity use means reduced carbon footprint
• Higher efficiency at high viscosity increases energy savings in your most difficult applications

Low shear handling for particulates and soft solids

• Improves batch consistency and final product quality
• Low shear action reduces the temperature increase of the pumped liquid to a minimum which is important when circulating products

Applications

Unloading – powerful, flexible, easy-to-clean

Certa Plus pumps have powerful suction capabilities. Their ability to prime even high viscosity products without running into cavitation makes them ideal for quick unloading applications, without causing damage to a system.

Transfer and circulation – hygienic, gentle, adaptable

Certa Plus is fully CIP proven to EHEDG and 3A standards, to avoid any potential product contamination caused by residuals after the cleaning process. The sinusoidal wave rotor design helps to gently transfer valuable pharmaceutical products with minimal shear to prevent product damage.

The pumps can be equipped with pump jacketing to maintain process and product temperature, making Certa Plus adaptable for a range of different circulation applications.

Versatile – robust fluid handling, rapid product change over

Across applications, varying temperatures result in varying viscosities. For example, in the production of suppositories, pumping at lower temperature means an increasing viscosity of the product.

With a seal flush Certa Plus is capable of transferring and handling challenging products from syrups and sugar solutions to lozenge products.

Meeting the future with up-to-date validation documentation

Certa Plus is rigorously tested to comply with the most up-to-date regulations required.

Technical

• Certa Plus delivers up to 41,760 l/h, 8 Million cP and 6 bar
• Standard ports to suit your application, including DIN, Tri-clamp TC, RJT and SMS with customised options on request.
• A space between the wet end (pumphead) and power end (bearing housing) of the pump, ensures fluid drains away in the event of a seal failure, eliminating the risk of contamination

Certification

The European Hygienic Engineering & 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. More

3-A SSI is an independent, not-for-profit corporation dedicated to advancing hygienic equipment design for the food, beverage, and pharmaceutical industries. 

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food

ATEX Directive (2014/34/EU): Machinery and equipment manufacturers, their authorised representatives, importers, or any persons responsible for placing a product on the market, must ensure that equipment falling under the ATEX Directive (2014/34/EU) prevents, or limits the impact to an adequate level of safety, an ignition of explosive atmospheres. As a visible sign of compliance with ATEX, the CE marking must be affixed to the equipment.

The U.S. Pharmacopeial Convention (USP) is an independent, nonprofit organization that safeguards the public’s health by developing quality standards for medicines, dietary supplements and food ingredients.

Options and accessories

Connection ports

Certa Plus pumps are available with all standard ports to match your application including DIN, Tri-clamp TC, RJT, and SMS. Customised options are available upon request.

Port orientations

Pumps can be configured with ports in a range of orientations to meet installation requirements, including a self-draining orientation.

Accessories

A static and dynamic flush system is available to clean the area behind the seal system. This is even possible with a single mechanical seal.

A jacketing system is available to allow pumps to be heated to the optimal temperature for your process.

Service and support

Customer Support

A network providing comprehensive support globally 

• Customer response centre 
• Global component and system solutions 
• Local technical field support

Genuine spares

MasoSine’s approved parts policy means that only the highest quality materials are used in the manufacture of our pumps. This gives our customers confidence that our pumps will not let them down.

Literature

Maintenance