Date of Award

2006

Document Type

Master Thesis

Degree Name

Masters of Science (Research)

Department

Cork Institute of Technology

First Advisor

Mr. Noel Duffy

Abstract

Solvent is the largest-volume raw material used at Janssen Pharmaceutical (Ire) Ltd. Over 2.2 million m3 were used in 2004. The top 13 solvents make up 99% of this amount. There are two main uses for solvent on site, processing and cleaning. Processing uses 55% of the total solvent used on site, cleaning uses the remainder.

Waste solvent forms the majority of the hazardous waste produced at Janssen. Three treatment options exist at present for this waste: incineration, recovery for reuse and energy recovery. All of the hazardous waste produced on site must be exported for these treatment options, due to a lack of facilities in Ireland at present. At present, Janssen recovers over 65% of waste solvent.

The current technology and the regulatory controls on equipment cleaning are investigated. The potential for solvent use reduction and substitution in cleaning operations is assessed. Cleaning method development studies are carried out on a number of processes on site. The four key factors for cleaning effectiveness: temperature, agitation, concentration (or chemical factor) and time (TACT) are investigated. The effectiveness of each of these factors is investigated and maximised through the use of a cleaning method design procedure. This includes solubility prediction guidelines, solubility testing, dip tests, laboratory cleaning trials and plant scale trials.

The lessons learned from these cases are combined and a generalised methodology for cleaning method development and streamlining is presented. This method is a new, risk- based approach to cleaning, incorporating input about both the process (residue) and the equipment. The method includes:

• Process chemistry studies to determine the exact nature of the residue(s)

• Prediction of solubility based on solubility thermodynamics theory

• Physical, chemical and pharmacological properties and their effect on cleaning

• An equipment cleaning review methodology

• Combination of the results into a risk analysis template

The method also includes guidance on equipment factors, cleaning limit calculation, cleaning validation and continuous cleaning method improvement.

The new cleaning method design approach developed represents an integrated approach, systematically addressing all aspects of a cleaning problem. It is generalised, and can therefore be used by any operator in the pharmaceutical industry to streamline cleaning operations or to develop new cleaning methods.

The project also includes an assessment of the environmental impacts of solvent waste incineration recovery versus incineration. A cumulative energy demand (CED) comparison of incineration versus recovery is carried out. Recovery is found to be the preferred waste management option for a variety of pharmaceutical waste solvent streams.

Access Level

info:eu-repo/semantics/openAccess

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