Complying with the stringent requirements, codes and standards ASME BPE, ISPE, FDA, EHEDG, 3-A

Promass P offers the enhanced performance of a bent tube meter and the drainability of a straight tube meter without any compromise. Now there is no need to trade-off between accuracy and drainability.


We understand measurement of quality critical control points and the subsequent control is a monumental responsibility. Our approach to the Life Sciences Industries is to supply flow measurement solutions and services that fully comply with the numerous industry-specific requirements, codes and standards such as: ASME BPE, ISPE, FDA, EHEDG and 3-A.

 

"ASME BPE Certificate of Compliance to relevant scope The scope for the Certificate of Compliance is based on the ASME BPE 2005 Standard. The Promass P fulfils the requirements of Parts, GR, SD, DT, MJ and SF that are deemed relevant to a Coriolis mass flow measuring system.

 

Promass P has a hygienic design as per the requirements of part SD, relating to sterility and cleanability. This allows the meter to fully drain using gravity not only in the vertical position but also in the horizontal, ensuring that there is no fluid held-up in the meter.

 

The product contact surface finish is electropolished as per part SF, guaranteeing Ra max =0.38 µm surface finish, not only for the process connection but also through the entire measuring tube. This ensures a clean, sterile and corrosion resistant sensor.

 

Promass P follows the guidelines of part MJ for joining methods, procedure qualification and examinations, ensuring a product that meets welding acceptance criteria.
Promass P with SS housing

Promass P complies with Part DT, including aspects of materials, dimensions and tolerances. Not only are the preferred material used for all wetted parts, but the exact composition is met. All relevant dimensions for hygienic clamp ends are met making sure of compatibility with your process. Additional DT requirements that are met are marking and packaging.

 

In total Promass P addresses over 40 specific requirements of the ASME BPE, guaranteeing a hygienic design for the bioprocessing, pharmaceutical, and personal care product industries. With 3-A authorization and EHEDG certification you can be ensured of this hygienic design and cleanability.

 

All process wetted materials, measuring tube and process connections are type ASTM 316L / EN 1.4435 complying with the Pharmaceutical/Biotech industry recommendation of the ASME BPE and BN2. Not only does the type of material conform but also the chemical composition; low delta ferrite and higher corrosion resistance.

The single tube hygienic design of Promass P incorporates eccentric process connections; this ensures complete drainability and cleanability even when the sensor is mounted in a horizontal position, guaranteeing no solution hold-up inside the flow tube. This makes Promass P ideal for skid mount applications. The fully welded hygienic design with no moving parts and no internal seals ensures maintenance free operation; this means no replacement of parts, no leakage due to seal deterioration and lower cost of ownership.

 

The single measuring tube technology has no flow splitter and is ideal for applications where minimal shear stress and careful handling of the product is necessary or in applications where low pressure loss is important. Promass P is easy to install and requires no inlet and outlet runs or flow profilers/conditioners.

 

Continuous measurement is required not only during normal production but also immediately after CIP/SIP cleaning processes.  Promass P withstands the frequent temperature stresses associated with cleaning and sterilization, providing measurement with no delay instantly after CIP/SIP "fast recovery no cool down period, which is sometimes associated with other single tube Coriolis meter manufactures. Promass P shows true application robustness regardless of the rate of change in temperature up to +200 °C. Resilient to temperature shocks, accuracy maintains 0.1% o.r. even during these cleaning periods.

 

Endress+Hauser offers accredited flow calibration according to ISO/IEC 17025 (SCS/A2LA/CNAS)  thus ensuring a guaranteed measuring accuracy of ±0.1% o.r. and a high repeatability of ±0.05% o.r.

furthermore making Promass P ideal for use as a master meter. In addition we offer traceable density calibration with different fluids and varying temperature.

 

At Endress+Hauser we understand that not all processes operate at reference conditions, that's why Promass P provides excellent accuracy not only at reference conditions but across the entire measuring range and at your specific operating point. Ensuring that you maintain accuracy over an entire process window regardless of changes in temperature, pressure density or viscosity.

 

Promass P is helping you to get "one step closer in PAT applications. Promass measuring devices are suitable for use in PAT applications for the continuous monitoring of critical quality process variables such as mass flow, volume flow, density and temperature.  Thus Promass P helps to achieve higher levels of manufacturing efficiency and quality assurance. FDA framework defines PAT as "a system for designing, analyzing and controlling manufacturing processes through timely measurements of critical quality and performance attributes of raw and in process materials. Promass P is capable of measuring real time process information that is made available to be used for process control or real time release. Promass P helps to bring the application one step closer to validated and qualified PAT process.

 

Promass P utilizes Endress+Hauser's proven Proline transmitter concept (standardized operation and electronic concept) supported by our worldwide sales and service network. This additionally includes on-site calibration, commissioning and control measurement for verification.

We have designed Promass P to provide you with a mass flow and density measurement solution that complies with your industry requirements and help to bring you one step closer to qualifying your process.