(189q) Optimizing the Pharmaceutical Cleaning Process: Challenges and Opportunities

Authors: 
Mouras, R., University of Limerick
Walker, G., Bernal Institute, University of Limerick
Albadarin, A. B., Bernal Institute, University of Limerick

Rabah.Mouras Normal Rabah.Mouras 2 111 2019-04-14T20:50:00Z 2019-04-14T20:50:00Z 1 386 2201 Microsoft 18 5 2582 14.00

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mso-bidi-font-size:13.0pt;line-height:150%;font-family:" calibri mso-ascii-theme-font:minor-latin new roman>Optimising the pharmaceutical
cleaning process: challenges and opportunities

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" calibri minor-latin new roman>Rabah
Mouras1,2
, Gavin Walker1,2 and Ahmad
Albadarin1,2

1 " calibri minor-latin new roman>
Department of Chemical Sciences, Bernal Institute, University of Limerick,
Castletroy, Limerick, Ireland

2 " calibri minor-latin new roman>Pharmaceutical
Manufacturing Technology Centre (PMTC), Bernal Institute, University of
Limerick, Castletroy, Limerick, Ireland

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normal"> font-family:" calibri minor-latin new roman>Abstract:

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" calibri minor-latin new roman>Cleaning
validation and verification is a regulatory requirement within the
manufacturing of active pharmaceutical ingredients (APIs) and drug products.
Thus production equipment in pharmaceutical plants ((reactors, dryers, pipes…)
need to be periodically cleaned to eliminate cross-contamination between
different products due to the adhesion of APIs, intermediates, by-products and
raw materials. This process has been proven to be very difficult, time
consuming and result in undesirable effects such as staining, and the
manufacturers strive to improve the efficiency, cost, quality, and time
required to design, qualify, and monitor the cleaning process. There is an
urgent need to optimize the cleaning process that leads to a high
competitiveness through reduced batches rejection, reduced laboratory costs,
and improved process yields and reduced changeover time.   

" calibri minor-latin new roman>Our
approach towards developing an efficient cleaning process is based on: (1)
selection of best cleaning agents with the help of modelling and solubility
predictions using conductor-like screening model for real solvents (COSMO-RS) that allows the
screening for innumerable solvents and mixtures, normal">(2) APIs and
intermediates solubility  measurement in
selected cleaning fluids, (3) cleaning trials using metal or
glass coupons in a dipping test apparatus to mimic the cleaning in plants, (4)
ensuring the surfaces are clean by means of spectroscopic and analytical
techniques and normal">(5) developing rinse solution analysis using process analytical
technology (PAT) methods.

" calibri minor-latin>Our approach allowed us to choose the most
efficient cleaning fluid resulting in a better cleaning with a considerable
reduction in time and usage of cleaning solvents.

" calibri minor-latin>In this presentation, theoretical and
experimental data will be presented and discussed and challenges in the
optimization and developing efficient cleaning process will be addressed.

normal">

normal">Key
words:
Pharmaceutical cleaning Process, Cleaning
validation,
Active Pharmaceutical Ingredient
(API), COSMO-RS, process analytical technology (PAT)

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normal">Acknowledgment: The research leading to these
results has received funding from Enterprise Ireland Innovation Partnership
Programme (IP-2018-0727).

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