Pressure Measurement & Control

Pressure measurement without risk of contamination

February 2024 Pressure Measurement & Control

Injectables are among the most sensitive products in the pharmaceutical industry. Sterility is essential during production. This is because the active ingredient enters the patient’s body directly, bypassing the patient’s natural defences. It is therefore important to prevent contamination during production at all costs. For this reason, a manufacturer of biopharmaceuticals decided to implement the pressure monitoring of its processes with hygienic instruments from WIKA. These are the model DMSU21SA pressure transmitter with flush connection and diaphragm monitoring, and the model PG43SA-S diaphragm pressure gauge.

If contaminated injectables were to enter the market, patients would be exposed to a huge risk of infection. The production of such injection solutions is therefore subject to the strictest regulations. The standards for maintaining product quality and for the sterility of the process steps, and the cleanability of pipes, tanks and instruments, are correspondingly uncompromising.

With a particular eye on injectables, the Food and Drug Administration (FDA) launched the New Inspection Protocol Project (NIPP) in 2018. The NIPP aims to get known quality problems under control through improved monitoring mechanisms, and to detect production errors in a timely manner before the entire batch has to be discarded.

Instruments for the increased safety requirements for injectables

Measuring instruments, for example for pressure monitoring, are indispensable safety components in all production processes. However, they can also be a cause of contamination, for example due to a damaged seal or a damaged measuring element.

In order to minimise such risks at critical points in its processes, the abovementioned manufacturer chose pressure measuring instruments from WIKA that meet its increased safety requirements. They use the DMSU21SA pressure transmitter in pre-formulation, recipe development, and in filtration. The instrument also monitors the pressure supply for both the sterilisation steam and the nitrogen, which maintains sterile conditions in the process after a SIP operation.

Pressure transmitter with diaphragm monitoring: a patented safety function

The DMSU21SA is a pressure transmitter with integrated diaphragm seal and diaphragm monitoring. The patented safety function of the EHEDG-certified and 3-A marked instrument works with a double diaphragm, the space between which is evacuated. If the process-side diaphragm is damaged under long-term extreme conditions, the vacuum is lost. A monitoring sensor immediately detects the pressure increase and sends an alarm signal, either via the HART protocol or via the current loop. The second diaphragm keeps the process reliably sealed until the damage can be repaired.

An additional advantage of the DMSU21SA is the easy installation based on the plug-and-play principle. As a result, existing measuring locations can also be retrofitted without additional effort.

Dry measuring diaphragm pressure gauge: ideal for tanks

The injectables are filled into tanks for transport between the individual process steps and for storage. The manufacturer now uses the hygienically-designed PG43SA-S diaphragm pressure gauge to monitor the pressure in the vessels. The instrument, also EHEDG certified and 3-A marked, works with dry measurement technology. This means the diaphragm element, which is welded flush with the front and without any dead space, transmits the pressure directly without any liquid. Contamination of the injectables, in the event of any damage, is therefore ruled out. Diaphragm pressure gauges are robust and generally feature high overload safety. Since they deliver reliable measurement results at all times without any external energy, they are particularly suitable for installation in tanks.


Share this article:
Share via emailShare via LinkedInPrint this page

Further reading:

VEGA handles the pressures of water treatment systems
VEGA Controls SA Pressure Measurement & Control
A water treatment system for a major metropolitan area in the Midwestern United States demands careful monitoring and management of processes across its sprawling network. Choosing VEGA for its process automation needs meant more than just obtaining precise and reliable pressure sensors.

Magnetostrictive level transmitter
WIKA Instruments Level Measurement & Control
WIKA’s new model FLM-Tx-FLEX magnetostrictive level transmitter is used for high-accuracy, continuous level detection of liquids, including those with long insertion lengths.

OEM high-pressure transducer with maximum long-term stability
Instrotech Pressure Measurement & Control
Instrotech is offering KELLER 10LHP, the flagship OEM pressure transducer in the KELLER product portfolio, which exemplifies the highest standards.

Chain hoist friction clutch tester
WIKA Instruments Motion Control & Drives
WIKA’s FRKPS chain hoist test set is a reliable and efficient way to test the friction clutch on your chain hoist.

Pressure sensors for hydrogen applications
Instrotech Pressure Measurement & Control
Keller manufactures isolated piezoresistive pressure sensors. The great advantage of the piezoresistive measuring principle is its high stability.

Sensor technology for cartonboard machine for paper and packaging
VEGA Controls SA Pressure Measurement & Control
Paper and packaging specialist, LEIPA undertook a comprehensive modernisation project, combining three stock preparation lines into one, and making investments in new plant components and extensive automation technology. Because of the good experiences the company had already had with VEGA sensors, those responsible for planning and maintenance decided in favour of the VEGABAR 82 pressure transmitter as the standard instrument for level and pressure measurement in the new stock preparation system.

In-line process transmitter to optimise sterile processes
WIKA Instruments Sensors & Transducers
The new model DMSU22SA in-line process transmitter from WIKA helps to optimise sterile processes in the pharmaceutical and food industries, with less energy consumption, less cleaning effort ,and more safety.

OEM pressure sensor for mobile working machines
WIKA Instruments Sensors & Transducers
The MH-4-CAN, based on the MH-4, is a powerful, reliable and extremely resilient pressure sensor for mobile working machines.

Pressure monitoring for oil and water tempering machines
Instrotech Pressure Measurement & Control
Temperature plays a significant role in many manufacturing processes. In such cases, a tempering machine is used to maintain the manufacturing process at the desired temperature. Keller supplied PR-21Y piezoresistive pressure transmitters to a client specialising in developing and producing oil and water tempering machines.

Universal temperature transmitter with drift detection
WIKA Instruments Temperature Measurement
The new model T38 digital temperature transmitter from WIKA enables extremely flexible and stable temperature measurement. The instrument offers a maximum of sensor connection combinations, and a new type of drift detection.