Dr Rabah Mouras : Successful Enterprise Ireland Capital Call 2020, €250k Awarded
Dr Rabah Mouras, Senior research fellow at PMTC, was successful in securing funding from the Enterprise Ireland Capital Call 2020 to acquire a cleaning rig to help Irish Pharma industries improve their cleaning process. The award (€250k) will help the development of a cutting-edge cleaning in place (CIP) skid equipped with multiple process analytical (PAT) tools and sensors for cleaning monitoring and verification. The assessment panel noted that cleaning is a critical process in the pharmaceutical industry in particular, and that the cost and downtime involved in cleaning are substantial. The panel also recognised that there was nothing similar in Ireland and that this was a critical piece of Infrastructure.
Pharmaceutical cleaning and subsequent verification and validation have always been time consuming and a costly operation in multipurpose pharmaceutical plants. ~ 50% of time is spent doing cleaning resulting in a significant impact on downtimes, costs and changeovers. Thus, pharmaceutical companies are actively looking for opportunities and appropriate infrastructures to help them optimising their cleaning protocols or developing new cleaning methodologies to reduce both time and cost of cleaning; whilst generating robust scientific data to support their cleaning procedures in front of regulatory agencies. The creation of such cleaning facility for the Pharma Industry, will have a transformative effect by allowing offline development and transfer of right first time cleaning processes to Pharma plants, which will help Irish based Pharma Manufacturing to better utilise the high value plants, maximising thus the processing time to achieve optimal productivity for companies.
The new CIP skid will be used to mimic the cleaning process in plant and to address some of the challenges that the pharmaceutical industry faces in cleaning by investigating and researching specific areas of cleaning. Automated CIP systems provide greater assurance that production residues are reliably and reproducibly removed through monitoring and control of process variables that are critical to cleaning process performance such as temperature, cleaning solution concentrations, flowrates and contact times.
The acquired skid will be designed to accept a whole range of PAT tools and sensors like Raman, FTIR, UV-VIS, TOC, conductivity, etc… along with additional outlets to use other techniques at line like flow cells for UV absorption, NMR spectroscopy or HPLC. By having all these capabilities, the process can be optimised taking real time decisions during the cleaning phase to allow equipment to be released back to production, and the samples will be sent to the quality control laboratories (QCLs) only when the cleaning is finished as verified by the PAT during cleaning phase. The PAT allow the operators to stop the cleaning when the residues concentration is at or below the limit required by the regulatory agencies.
The facility planned with the cleaning skid at PMTC will help optimising and speeding up the cleaning process and enable the combination of PAT and CIP providing enormous value to Pharma sites by reducing time and resources tied up in cleaning whilst also increasing manufacturing capacity. The new facility will allow rapid and seamless knowledge transfer from PMTC to industry and vice versa.
IMPACT ON THE CENTRE’S RESEARCH ACTIVITIES
The new equipment will help PMTC expand the scope of research where previous lack of infrastructure presented limitations. The use of a CIP skid with features replicating the plants’ equipment, will make the obtained data easily translated from PMTC labs to the Industrial application. Our goal is to maximise the impact of our research which will in turn enhance our industrial engagement and broaden the reach of PMTC. PMTC also anticipate that this capability will open new doors for new research themes in other related areas like green chemistry, environment, (recycling and solvents recovery) and energy generation. The new equipment will strengthen the centre’s infrastructure and will allow for new collaborations with industry in the pharmaceutical and biotech areas.
At PMTC, we are excited to develop this capability with this capital award and look forward to many industrial collaborations in the future.
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