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 instrument the pressure monitoring of its processes with hygienic instruments from WIKA. These are the model DMSU21SA pressure transmitter with flush connection and diaphragm monitoring as well as 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 as well as 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, i.e. before the entire batch has to be discarded.
Instruments for the increased safety requirements for injectables
Used in the production of injectables: the WIKA DMSU21SA (l.) and PG43SA-S pressure measuring instruments.
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 manufacturer mentioned above chose pressure measuring instruments from WIKA that meet its increased safety requirements. They use the DMSU21SA pressure transmitter in pre-formulation and recipe development as well as 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.
Note
You can find out more on the technical details of the previously mentioned DMSU21SA and PG43SA-S pressure measuring instruments on the WIKA website. There you will also find an overview of other measurement solutions for the pharmaceuticals and biotechnology. If you have any questions, your contact will gladly help you.
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You can also find out more about the patented diaphragm monitoring in the following video