Bio Technology / High Containment
Mr. Gregg Herreman: (Fluor Daniel Inc. Greenville USA.
Mr. Gregg Herreman is a well known as a Speaker on containment technology and is a Senior Containment Specialist.in the United States. Greg has 28 years experience in the Pharmaceutical and Biotechnology Industry Globally.
He has extensive international experience in Formulation Process Development, Packaging, Process Start-up for Solid liquid,, perential and bulk products.
The technology of containment is one of the fastest developing design issues faced by the Industry. Your demands today of producing product are greater and more complex than ever before.
The challenges placed on you to research and develop the next generation of wonder drugs is only matched by the challenges placed on your Design and Production Teams to produce these drugs.
Gregg will outline how you could meet these demands, how you may overcome the issues, how you could set new standards for your Designer and Producer.
The concept of Manufacturing in a safe environment is as old as the practice of medicine.
However,
Operator Environment Safety, Product Containment, Facility Cost, Equipment availability and delivery are all issues that face us today.
Case Study "Plant Modular Construction"
John Sweeney, IE16 Lead Automation Engineer, Eli Lilly, Co. Cork
John is a graduate engineer from the Cork Institute of Technology, is a past Program Chairman and Treasurer of ISA Ireland. He is a DCS Programmer with over 14 years experience working on automation projects primarily in the pharmaceutical industry.
John's paper will discuss the facility design strategies and automation system designs used to facilitate the delivery of the modular manufacturing building.
"...speed to market
and facility
lift cycle costs
are key to a
companies success as a
manufacturer of
medicines...." |
In our highly competitive pharmaceutical manufacturing sector, where in addition to GMP requirements, speed to market and facility lift cycle costs are key to a companies success as a manufacturer of medicines, novel methods of facility delivery pose great opportunities in achieving these gaols.
Eli Lilly S.A. who have been manufacturing medicines in Ireland for over 20 years took the decision to attempt to reduce facility delivery costs and schedule for their newest manufacturing facility through the use of modular construction techniques.
Environmental Risk Management - Due Diligence
Dr Graham Parry: Exec. Dir., RPS Group plc
Dr. Parry is a Director of RPS Group plc, they are the largest independent environmental consultancy in Europe. Graham has over 25 years experience in environmental management in the public and private sectors. For the past 12 years he has been responsible for the development of the Risk Management division of the group.
Using case studies Dr. Parry's paper will describe how your environmental liabilities can be assessed as manageable business risks. These risks can then be imported into economic models. He will describe the process of assessment including identification of liabilities arising from your plants historic uses and issues relating to your current activities and processes.
The concept of materiality will be discussed and how the results of environmental due diligence can be used to prevent excessive discounting and assist in maintenance of value.
Environmental issues have become a standard feature of Due Diligence in transactions of all sizes. Purchasers and sellers recognise the broad range of industries where this has to be considered.
Approaches to the Validation of a Biotechnology Facility.
Dr Trevor Deeks, Manager of Validation, Fluor Limited, UK
Trevor has 22 years experience in pharmaceutical manufacturing, development, quality assurance and validation. He is a registered pharmacist and he has experience of a wide range of validation projects which includes conducting mock inspections and audits.
Trevor joined Fluor Ltd. in November 2000 and previously held senior positions with the Washington Group, Boehringer Ingelheim and Marion Merrell Dow.
He has acted as an auditor for both the WHO and UNICEF of suppliers of vaccines and essential drugs. He has published over 30 papers in peer reviewed journals and books including the Pharmaceutical Codex.
He has sat on a number of BSI, CEN, ISO and European Pharmacopoeia Commission expert working groups. He is a Past Chairman of the Parenteral Society and was Editor-in-Chief of the European Journal of Parenteral Sciences from 1996-2000.
Trevor's presentation will outline the different approaches open to you in the validation of your biotechnology facility. He will discuss the different approaches that are used and outline the factors that will influence the approach you should take. Mr. Deeks will address the regulatory considerations and his experiences gained over the years in this area.
He will use an illustrative example to outline a successful validation approach for a multi-million pound Biotechnology project
Environmental Regulation in Ireland - from IPC to IPPC
John Feehan, Inspector (E.P.A)
"...background to IPC Licensing,
its implementation to date
and a look forward to the
implications of IPPC ...." |
John Feehan
is an Inspector with the Environmental Protection Agency. He is based
at the EPA Regional Inspectorate, at Inniscarra, Co. Cork. John joined
the EPA in 1995 where he initially worked in the strategic management
and policy areas before moving to the Licensing and Control Division.
Graduated in Environmental Science & Technology from Sligo Institute
of Technology and in Environmental Chemistry from University College
Cork. He previously worked in the Pharmacuetical Manufacturing
Industry for five years.
This presentation will look at the background to IPC Licensing, its implementation to date and a look forward to the implications of IPPC.
The EPA is responsible for the licensing and regulation of large/complex industrial and other processes with significant polluting potential on the basis of Integrated Pollution Control (IPC), and having regard to the best available technologies for these purposes.
The Environmental Protection Agency Act, 1992, established a new institutional framework for the control of environmental pollution in Ireland.
Fluidised Bed Incineration Technology
Ms. Laura Burke, (Indaver Ireland )
Graduated in Chemical Engineering from University College Dublin in 1992. In 1995 Laura joined MinChem Environmental Services Ltd as Technical Manager. MinChem export hazardous waste to Britain and the Continent for recovery or disposal. In November 1999 Indaver (a Belgian Waste Management Company) acquired a 60% shareholding in MinChem. Laura was appointed as Operations Manager of Indaver Ireland, a new company set up to implement integrated waste management in Ireland.
Indaver Ireland is preparing a planning application for an Industrial/ Municipal Waste Incinerator for the treatment of Hazardous and Non- Hazardous Waste, in Ringaskiddy.
LauraÕs paper will give details on the proposal for the disposal of Industrial waste in a Fluidised Bed Incinerator.
Fluidisation is the term applied to the process whereby a fixed bed of fine solids is transformed into a liquid-like state by contact with an upward flowing gas.
