Expert pressure measurement optimised for hygienic applications should not end at flush-mounted process adaptation. The CerabarM transmitter also offers a housing designed with safety in mind, featuring complete modularity for process connections and electronics. Producers of pharmaceuticals receive competent support for their process validation and the certainty of expert pressure measurement.
Transferring chemical-pharmaceutical processes from the laboratory into production, with the necessary standards is especially challenging. In addition to a wide range of process-specific factors which must be observed, national legislature and international supervisory bodies make great demands on the initial, intermediate and end products of pharmaceutical processes. Moreover, it is also important to be prepared for future requirements especially when initially planning a production process. In order to meet these demands, all steps and risks on the path towards a professional plant with safe, reliable and on-schedule production with high yields are listed in a validation master plan. Integral parts of a plant, such as the machines, material and measuring technology are qualified to ensure that they are in perfect working order and reliable for the objective in question. You must ensure that the pharmaceutical production plant meets all requirements right from the initial concept phase of the plan.
Pressure measurement from Endress+Hauser takes these challenges into account, since pressure and hydrostatic level are also important parameters in modern pharmaceutical processes. The hygienic pressure sensor CerabarM, in particular, fulfils all criteria for use in pharmaceutical plants, such as its proven hygienic construction and ability to be cleaned, use of materials which are not hazardous to health and a wide range of flush-mounted, hygienic process connections.
CerabarM provides the user with a choice between two expert sensor principles. The heart of the pressure transmitter is either a piezo-resistive sensor with a metallic measuring membrane or a capacitive ceramic measuring cell, which works without filling oil. Ceramic is the first choice for applications that demand a high level of robustness, corrosion-resistance and absolute vacuum proofing, while piezo-resistive technology is used especially in measuring ranges over 4 MPa (40 bar).
While there are different technologies behind these pressure measurements, both versions have one feature in common, namely unrestricted suitability to pressure sensing - which is overload-proof and stable over a long term - in pharmaceutical processes with a high level of accuracy.
Hygienic design from the sensor to the housing
Only materials categorised by the FDA as being nonhazardous to health are in contact with the process. These materials include the high-purity Ceraphire ceramic (99,9% Al2O3) including seal (eg. EPDM, NBR). All metallic parts of the CerabarM that are accessible from the outside are made from AISI 316 L, which is standard in pharmaceutical plants. The ceramic measuring cell works dry, ie without any filling fluid. The piezo-resistive sensors use filling oils which, for safety reasons, are also not hazardous to health should the metallic diaphragm become damaged. Both sensor technologies allow the CerabarM to be used without restrictions during CIP and SIP. Thanks to the optimum interaction between the sensor and evaluation electronics, measuring can take place continuously at temperatures up to 125°C and for an hour up to 150°C without the need to temperature-decouple the transmitter. CrNi-steel 316 L is also the standard material for the high-grade steel housing of the CerabarM. The construction of this housing is tailor-made to fulfil the requirements for hygienic applications. Cleaning cycles are not only mandatory for the processes but the area surrounding the production plant is also cleaned on a regular basis. The user has the safety to do so thanks to the housing designed without corners or edges together with ingress protection up to 1P68. Minimised volume and optimised scaling concept ensure the highest level of protection against moisture and resistance to condensation.
A wide range of process connections is available for using the CerabarM in pharmaceutical applications, including:
* Flanges in accordance with DIN or ANSI.
* Sanitary connections in accordance with DIN 11851.
* Aseptic connections in accordance with DIN 11864-1-A.
* Clamp connections.
* DRD tank adapters.
* Tuchenhagen Varivent Inline connections and tank adapters.
* Neumo sterile connection, Bioconnects.
* APV Inline connections and tank adapters.
* Mettler Toledo welding sockets.
All connections have a superior finish on the sides in contact with the process and can be selected in different nominal diameters. Since low-capacity containers and tubes with a small nominal diameter are often used in plants producing pharmaceuticals, Endress+Hauser paid special attention to small hygienic process connections with the Cerabar M.
All the connections have the essential qualifications for the pharmaceutical industry, such as the 3-A certificate on hygienic construction from the Sanitary Standards Administrative Council (USA), the report from the EHEDG (European Hygienic Equipment Design Group) on the pressure sensor's unrestricted ability to be cleaned and confirmation that only materials conforming to the FDA have been used. Thanks to the modular concept, a process connection required for the application can be adapted to the CerabarM at a later date.
The modular concept applies to both the process and the electronics. In this way, users can choose between evaluation electronics with standardised analog signals 4 to 20 mA, digital HART protocol or certified PROFIBUS-PA to the current Profile 3,0 (also available in an intrinsically safe version.)
Endress+Hauser provides customer support throughout planning and set-up, including maintenance for effective and inexpensive validation. For design qualification, material certificates and certificates on the ability to be cleaned, etc. are produced to prove that the measuring technology is suited to the process. Calibration protocols, instrument calibration and a detailed spare parts concept assist the installation qualification (IQ) phase. If necessary, the company can also be of assistance when installing the measuring instruments.
The project team can be assisted with operational qualification (OQ) and concluding performance qualification (PQ) in which the plant is operated systematically on a trial basis and the plant functions are tested under norma1 and exceptional operating conditions. There is also assistance offered when drafting up standard operating procedures and training courses for the operating staff.
For further scheduled operation of the plant (on-going evaluation), Endress+Hauser can provide the client with services such as regular on-site calibration of the measuring units to comprehensive service contracts, as required.
For more information contact: Grant Joyce, Endress+Hauser, tel: 011 262 8000, www.za.endress.com
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