News

6November2008

London Workshop Radiation Sterilization of Combination Drug-Device Products

On Thursday the iiA sponsored the third workshop on the Radiation Sterilization of Advanced Combination Drug-Device Products. New generation combination products that contain a drug or another biological active component are demanding sterilization be considered earlier in the research and development process– this requires fresh thinking, scientific based approaches to deal with these complex, temperature […]

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10October2008

ISO TC34/WG 10 Food Irradiation Meeting

Convenor Romina Garay (IRAM, Argentina) held the first meeting of WG 10 at the British Standards Institute (BSI) on 18-19 September to take advantage of industry experts in London attending IMRP 2008. Attendance included the ISO/TC 34 Secretary (Jean Baptiste Finidor, AFNOR France) and experts from five countries – 2 from Argentina, 1 from Australia, […]

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19September2008

ISO/TC 34/WG 10 London Meeting

18-19 September 2008 | Report on ISO/TC 34/WG 10 Meeting at the British Standards Institute, London, UK by Rod Chu and Ruth Brinston, Canadian Expert Members of WG 10 and Report by the Convenor Romina Garay. Background Work on the ISO food irradiation standard began in 2004. However, because the ISO time lines were not […]

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4August2008

Sterility and Safety Assurance of Medical Devices, 1992

Here is the classic paper on “Sterility and Safety Assurance of Medical Devices” was published April 1992 in Medical Device and Diagnostic Industry. by Canon Communications and reprinted by the US Department and Health Services and CDC. Authors .F. Morrissey, PhD; C.W. Bruch, PhD; R.J. Sharbaugh, PhD; M.S. Favero, PhD; Jarvis and Masefield discuss the […]

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30July2008

123 The behaviour of alanine dosimeters at temperatures between 100 K and 300 K

11:50 – 12:10 – 12:30 Tuesday 23 September | Heathcare 2: Process Peter H G Sharpe, J P Sephton and C A Gouldstone: National Physical Laboratory, Teddington, TW11 0LW, UK E-Mail: peter.sharpe@npl.co.uk Abstract A cryostat has been constructed to enable irradiations in a MDS Nordion Gammacell 220 irradiator to be carried out at selected temperatures […]

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30July2008

208 The use of low dose -cryo-irradiation’ in therapeutic cancer vaccine production

11:30 – 11:50 Tuesday 23 September | Heathcare 2: Process Stephen Ward: Onyvax Limited, London, United Kingdom E-Mail: sward@onyvax.com Abstract Therapeutic vaccine strategies can be used to harness the selective power of the immune system to treat life-threatening cancer. The use of whole tumour cells as a vaccine strategy is advantageous as the resulting formulation […]

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30July2008

210 Combination products – What effects might processing conditions and product composition have on microbial radiation response?

11:00 – 11:30 Tuesday 23 September | Heathcare 2: Process Alan Tallentire: Air Dispersions Ltd, Manchester, UK E-Mail: Abstract The sterilization of drug-device combination products can necessitate the use of radiation processing conditions significantly different from those normally employed for the sterilization of medical devices. To minimise the detrimental effect that exposure to radiation can […]

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30July2008

222 Regulatory Approaches for Novel Processing and Innovative Products

9:30 – 9:55 Tuesday 23 September | Heathcare 2: Process Anastasia Lolas: Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration E-Mail: Abstract Recent global developments such as the harmonization of regulatory standards and scientific and technological advances have led to the reexamination of traditional terminal sterilization cycles. The dosing […]

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30July2008

225 Product and Process Convergence

8:40 – 9:05 Tuesday 23 September | Heathcare 2: Process David Liu: Johnson & Johnson – World Wide Supply Chain/Operations P.O. Box 16594 New Brunswick, NJ 08906-6594 USA E-Mail: Abstract Over the last 25 years, medical science has advanced at an unprecedented rate. During this time, a wide range of radiation-compatible materials was developed. Medical […]

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