2013 Conference
16th GERPAC Conference
11th European GERPAC
Pharmaceutical Technology and risk management in hospital pharmacies
11th European GERPAC
Pharmaceutical Technology and risk management in hospital pharmacies
Risk management for sterile preparation in hospital pharmacies (part I)
Managing risks with the Science of Danger
Michel Lesbats
IUT HSE Department
Bordeaux 1 University Risk Evaluation for Aseptic Preparation A. M. Beaney Regional Quality Assurance Specialist
North-East England, UK Management of a microbial contamination incident Irene Krämer Department of Pharmacy, University Medical Center,
Johannes Gutenberg-University, Langenbeckstraße 1,
55131 Mainz, Germany Validation of Hydrogen Peroxide Sanitisation of Isolators – Critical Points to be Considered Tim Coles Director. Pharminox Isolation Ltd.
Cambridge, UK
Bordeaux 1 University Risk Evaluation for Aseptic Preparation A. M. Beaney Regional Quality Assurance Specialist
North-East England, UK Management of a microbial contamination incident Irene Krämer Department of Pharmacy, University Medical Center,
Johannes Gutenberg-University, Langenbeckstraße 1,
55131 Mainz, Germany Validation of Hydrogen Peroxide Sanitisation of Isolators – Critical Points to be Considered Tim Coles Director. Pharminox Isolation Ltd.
Cambridge, UK
Risk management for sterile preparation in hospital pharmacies (part II)
Moderators
S. Crauste-Manciet (Saint Germain en Laye - France)
P. Odou (Lille - France) Mab’s Stability Issues Andrew G Watts Medicinal Chemistry group,
department of pharmacy and pharmacology,
University of Bath, UK Risk of Chemical Exposure and Gloves Permeability A. Capron Cliniques Universitaires Saint-Luc, Laboratoire de Biochimie Analytique.
Bruxelles, Belgique. Personal protective equipment for preparing toxic drugs L. Power Senior Pharmacy Consultant,
Power Enterprises, San Francisco, California, USA
Review of urine biological monitoring of toxic drugs J.F. Bussières B Pharm, M Sc, MBA, chef du département de pharmacie et de l’Unité de recherche en pratique pharmaceutique (URPP) CHU Sainte Justine, Montréal, Québec, Canada et Professeur titulaire de clinique, Faculté de pharmacie, Université de Montréal ;
en collaboration avec Cynthia Tanguay, B Sc, M Sc, coordonnatrice URPP
et Myriam Berruyer, assistante de recherche URPP
P. Odou (Lille - France) Mab’s Stability Issues Andrew G Watts Medicinal Chemistry group,
department of pharmacy and pharmacology,
University of Bath, UK Risk of Chemical Exposure and Gloves Permeability A. Capron Cliniques Universitaires Saint-Luc, Laboratoire de Biochimie Analytique.
Bruxelles, Belgique. Personal protective equipment for preparing toxic drugs L. Power Senior Pharmacy Consultant,
Power Enterprises, San Francisco, California, USA
Review of urine biological monitoring of toxic drugs J.F. Bussières B Pharm, M Sc, MBA, chef du département de pharmacie et de l’Unité de recherche en pratique pharmaceutique (URPP) CHU Sainte Justine, Montréal, Québec, Canada et Professeur titulaire de clinique, Faculté de pharmacie, Université de Montréal ;
en collaboration avec Cynthia Tanguay, B Sc, M Sc, coordonnatrice URPP
et Myriam Berruyer, assistante de recherche URPP
Focus on pharmaceutical technology
Moderators
D. Brossard (Paris - France)
ML Brandely (Paris - France) Manufacturing of Viral vectors for gene therapy Christophe Cochet Directeur Qualité Généthon
Selection criteria for the preparation of anticancer drugs from generic drugs P. Hild1 et V. Grangeon-Vincent2 1 Service Pharmacie, CH de Roanne, France
2 Service Pneumologie, CH de Roanne, France
ML Brandely (Paris - France) Manufacturing of Viral vectors for gene therapy Christophe Cochet Directeur Qualité Généthon
Selection criteria for the preparation of anticancer drugs from generic drugs P. Hild1 et V. Grangeon-Vincent2 1 Service Pharmacie, CH de Roanne, France
2 Service Pneumologie, CH de Roanne, France
Short oral scientific communications
Moderators
D. Brossard (Paris - France)
Y. Huon (Liège - Belgium)
F. Sadeghipour (Lausanne - Switzerland) Alternative to chlorides in parental nutrition solutions: Clinical relevance and feasability L. Boissinot, C. Bontour-Lebon, M-L Brunet, F. Chast 27 rue du Faubourg Saint-Jacques
Hôpitaux Universitaires Paris Centre, 75014 PARIS Formation of particles while preparing infusion bags : case report Isabelle Roland, Pierre-François Demeuldre, Gaëtan Van Haren, Yvan Huon Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Validation of a Rotary Vial washer for terminally sterilized product manufacture Andrew Sully, Catherine Talbot Cardiff and Vale University Health Board, SMPU,
Cardiff, Wales, UK Risk assessment of the pharmacy preparations in health care establishments Flora Capelle1,Marie-Pauline Gagaille2, Omar Hassaine3,Gaëtan Van Haren4 1 Service Pharmacie Stérilisation, Hôpitaux Universitaires de Strasbourg, France
2 Service Pharmacie Stérilisation, Hôpital Beaujon APHP, France
3 Service Pharmacie Stérilisation, Centre Hospitalier Poissy St Germain, France
4 Service Pharmacie Stérilisation, CHU de Liège, Belgique Intravenous chemotherapy preparation : risk analysis Claire-Hélène Henry, Véronique Graff, Franck Couturier Pharmacy – Sainte Anne clinical (GHSV)
Strasbourg, France. Feedback about incidents on CHIMIO® software Julien Duquesne, Nassir Mirfendereski, Rémy Collomp, Sandra Ruitort Service Pharmacie, Hôpital l’Archet,
CHU de NICE, France Working conditions in a pharmaceutical compounding unit: Impact of automation of parenteral nutrition elaboration J. Tavernier1, E. Thibert1, M. Van Hollebeke1, M. Jouannet1, V. Sautou1,2, J. Chopineau1,2 1- Service Pharmacie, CHU Clermont-Ferrand
2- UFR Pharmacie Clermont 1, Université d’Auvergne Development of a simple and robust motorized apparatus designed to minimize the risk of musculo-skeletal disorders: application to the filling of portable infusion pumps A. Amin1, C. Violain1, K. Collet1, C. Dupont2, B-L Jaouani3, R. Loeuillet1, L. Simoes1, N. Thromas1, E. Gohier4, P. Bourget1 1 Service de Pharmacie Clinique, HU Necker-Enfants Malades - 149 rue de Sèvres, 75015 Paris, France;
2 HU Cochin - 27 rue du Faubourg Saint-Jacques, 75014 Paris, France ;
3 Cabinet d’HAD Vicene-Paris Transpatient - 268 rue de Charenton, 75012 Paris, France ;
4 JCE Biotechnology - Bioparc Vichy BP7, 03270 Hauterive, France Evaluation of microbiological contamination of ready to use plastic ampoules Michel Deprez, Jérôme Hack, Yvan Huon, Isabelle Roland Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Validation of bacterial endotoxin test for injectable batch produced cytotoxic drugs P.H. Secrétan, MN-G. Guerrault-Moro, R. Vazquez, S. Crauste-Manciet CHI Poissy Saint Germain-en-Laye, 20 rue Armagis,
Saint Germain-en-Laye, 78105. France Investigation into Rapid (Alternative) Microbial Detection Methods (RMM) to improve the QA of NHS manufactured aseptic products SJ. Hiom, C. Talbot, P. Spark, J. Smith, SD. Denyer SMPU, Cardiff and Vale University Health Board, NHS Wales, UK
Quality of parenteral nutrition mixtures: is it improved by the use of an automated compounding device? M. Van Hollebeke1, E. Thibert1, B. Perreira2, M. Jouannet1, V. Sautou1, J. Chopineau1 1 CHU Clermont-Ferrand, Pharmacie, Hop G Montpied, 58 rue Montalembert, F-63000 Clermont-Ferrand, France
2 CHU Clermont-Ferrand, délégation à la recherche clinique et innovation, Hop G Montpied, 58 rue Montalembert, F-63000 Clermont-Ferrand, France Evaluation of the stability of a 10mg/mL Cefuroxime solution for intracameral injection in new sterile vials Frédéric Feutry1,2, Nicolas Simon2,3, Stéphanie Genay1,2, Tsanta Radaniel,2, Damien Lannoy1,2, Christine Barthélémy2, Bertrand Décaudin1,2, Pascal Odou1,2 1 University Hospital Centre, Pharmacy Institute, Lille, France
2 Department of Biopharmacy, Galenic and Hospital Pharmacy,EA GRIIOT, UFR Pharmacie, Lille,
France
3 Oscar Lambret Centre, Oncology Pharmacology Unit, Lille, France Control of parenteral nutrition mixtures: validation of a laboratory robot to control physicochemical environment in binary mixtures F. Ruiz, M. Nouman, C. Jaskowiec, S. Poullain. CHI Créteil Service de Pharmacie, 40 avenue de Verdun,
94000 Créteil, France Reliability of the chemotherapy preparation process: double check or gravimetric control? Laurent Carrez, Lucie Bouchoud, Sandrine Fleury, Christophe Combescure, Farshid Sadeghipour, Pascal Bonnabry Pharmacie des Hôpitaux Universitaires de Genève, Section des sciences pharmaceutiques, Université de Genève, Université de Lausanne, Genève, Suisse How to assess the workload generated by clinical trials preparation in a compounding Olivia Niessen, Yvan Huon, Isabelle Roland Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Oral and topic anticancer drug preparation: state of the art, manufacturing, and ambulatory dispensation Philippe Garrigue*1, Anaïs Breteau*2, Florence Moissette*3, Céline Saint-Laurent*4, Bertrand Pourroy1, Pascale Pisano1 *Co-auteurs
1 CHU La Timone, Marseille,
2 CHU Charles Nicolle, Rouen,
3 Hôpitaux Universitaires de Strasbourg,
4 CH Marne la Vallée Creation of an auditing tool for an aseptic preparation unit according to the french good preparation practices (GPP) - Assessment of a chemotherapy preparation unit Lucie Baillet1, Latifa Haddad1, Michèle Vasseur1, Christophe Berneron1, Amandine Menet2, Christophe Lestrez3, Bertrand Decaudini1, Pascal Odou1 1 Institut de pharmacie, CHRU Lille, France
2 Ingénieur qualité, CHRU Lille, France
3 Ingénieur responsable de la qualité de l’air, CHRU Lille, France Qualification of new pharmacotechnical operators A. Venet, M. Grouvel, C. Bedoucha, B. Roussely, A. Jourand Unité de préparation stérile - pharmacie,
CHU de Bordeaux Groupe Hospitalier Pellegrin,
Application of educational films for staff training in parenteral nutrition unit P. Legrand, J. Bordenave, C. Cambier, F. Nadji, G. Benoit Pharmacie, Hôpital Armand Trousseau AP-HP / HUEP,
26 avenue du Docteur-Arnold-Netter
75571 Paris cedex 12, France Pharmacy technicians education: an innovative pedagogical tool L. Danguy des Déserts, C. Nowak, I. Baudin Centre Hospitalier d’Angoulême
Hand’s microbiocontamination in Cytotoxic Reconstitution Unit (CRU) R. Picot-Guéraud1, C. Fayard1, N. Sylvoz1, I. Federspiel1, A. Lemoigne1, L. Foroni1, P. Saviuc2, M-R. Mallaret2 CHU de Grenoble, France.
1 : Pôle Pharmacie,
2 : Unité d’Hygiène Hospitalière
Y. Huon (Liège - Belgium)
F. Sadeghipour (Lausanne - Switzerland) Alternative to chlorides in parental nutrition solutions: Clinical relevance and feasability L. Boissinot, C. Bontour-Lebon, M-L Brunet, F. Chast 27 rue du Faubourg Saint-Jacques
Hôpitaux Universitaires Paris Centre, 75014 PARIS Formation of particles while preparing infusion bags : case report Isabelle Roland, Pierre-François Demeuldre, Gaëtan Van Haren, Yvan Huon Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Validation of a Rotary Vial washer for terminally sterilized product manufacture Andrew Sully, Catherine Talbot Cardiff and Vale University Health Board, SMPU,
Cardiff, Wales, UK Risk assessment of the pharmacy preparations in health care establishments Flora Capelle1,Marie-Pauline Gagaille2, Omar Hassaine3,Gaëtan Van Haren4 1 Service Pharmacie Stérilisation, Hôpitaux Universitaires de Strasbourg, France
2 Service Pharmacie Stérilisation, Hôpital Beaujon APHP, France
3 Service Pharmacie Stérilisation, Centre Hospitalier Poissy St Germain, France
4 Service Pharmacie Stérilisation, CHU de Liège, Belgique Intravenous chemotherapy preparation : risk analysis Claire-Hélène Henry, Véronique Graff, Franck Couturier Pharmacy – Sainte Anne clinical (GHSV)
Strasbourg, France. Feedback about incidents on CHIMIO® software Julien Duquesne, Nassir Mirfendereski, Rémy Collomp, Sandra Ruitort Service Pharmacie, Hôpital l’Archet,
CHU de NICE, France Working conditions in a pharmaceutical compounding unit: Impact of automation of parenteral nutrition elaboration J. Tavernier1, E. Thibert1, M. Van Hollebeke1, M. Jouannet1, V. Sautou1,2, J. Chopineau1,2 1- Service Pharmacie, CHU Clermont-Ferrand
2- UFR Pharmacie Clermont 1, Université d’Auvergne Development of a simple and robust motorized apparatus designed to minimize the risk of musculo-skeletal disorders: application to the filling of portable infusion pumps A. Amin1, C. Violain1, K. Collet1, C. Dupont2, B-L Jaouani3, R. Loeuillet1, L. Simoes1, N. Thromas1, E. Gohier4, P. Bourget1 1 Service de Pharmacie Clinique, HU Necker-Enfants Malades - 149 rue de Sèvres, 75015 Paris, France;
2 HU Cochin - 27 rue du Faubourg Saint-Jacques, 75014 Paris, France ;
3 Cabinet d’HAD Vicene-Paris Transpatient - 268 rue de Charenton, 75012 Paris, France ;
4 JCE Biotechnology - Bioparc Vichy BP7, 03270 Hauterive, France Evaluation of microbiological contamination of ready to use plastic ampoules Michel Deprez, Jérôme Hack, Yvan Huon, Isabelle Roland Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Validation of bacterial endotoxin test for injectable batch produced cytotoxic drugs P.H. Secrétan, MN-G. Guerrault-Moro, R. Vazquez, S. Crauste-Manciet CHI Poissy Saint Germain-en-Laye, 20 rue Armagis,
Saint Germain-en-Laye, 78105. France Investigation into Rapid (Alternative) Microbial Detection Methods (RMM) to improve the QA of NHS manufactured aseptic products SJ. Hiom, C. Talbot, P. Spark, J. Smith, SD. Denyer SMPU, Cardiff and Vale University Health Board, NHS Wales, UK
Quality of parenteral nutrition mixtures: is it improved by the use of an automated compounding device? M. Van Hollebeke1, E. Thibert1, B. Perreira2, M. Jouannet1, V. Sautou1, J. Chopineau1 1 CHU Clermont-Ferrand, Pharmacie, Hop G Montpied, 58 rue Montalembert, F-63000 Clermont-Ferrand, France
2 CHU Clermont-Ferrand, délégation à la recherche clinique et innovation, Hop G Montpied, 58 rue Montalembert, F-63000 Clermont-Ferrand, France Evaluation of the stability of a 10mg/mL Cefuroxime solution for intracameral injection in new sterile vials Frédéric Feutry1,2, Nicolas Simon2,3, Stéphanie Genay1,2, Tsanta Radaniel,2, Damien Lannoy1,2, Christine Barthélémy2, Bertrand Décaudin1,2, Pascal Odou1,2 1 University Hospital Centre, Pharmacy Institute, Lille, France
2 Department of Biopharmacy, Galenic and Hospital Pharmacy,EA GRIIOT, UFR Pharmacie, Lille,
France
3 Oscar Lambret Centre, Oncology Pharmacology Unit, Lille, France Control of parenteral nutrition mixtures: validation of a laboratory robot to control physicochemical environment in binary mixtures F. Ruiz, M. Nouman, C. Jaskowiec, S. Poullain. CHI Créteil Service de Pharmacie, 40 avenue de Verdun,
94000 Créteil, France Reliability of the chemotherapy preparation process: double check or gravimetric control? Laurent Carrez, Lucie Bouchoud, Sandrine Fleury, Christophe Combescure, Farshid Sadeghipour, Pascal Bonnabry Pharmacie des Hôpitaux Universitaires de Genève, Section des sciences pharmaceutiques, Université de Genève, Université de Lausanne, Genève, Suisse How to assess the workload generated by clinical trials preparation in a compounding Olivia Niessen, Yvan Huon, Isabelle Roland Pharmacie hospitalière CHU Liège,
B4000 Liège, Belgique Oral and topic anticancer drug preparation: state of the art, manufacturing, and ambulatory dispensation Philippe Garrigue*1, Anaïs Breteau*2, Florence Moissette*3, Céline Saint-Laurent*4, Bertrand Pourroy1, Pascale Pisano1 *Co-auteurs
1 CHU La Timone, Marseille,
2 CHU Charles Nicolle, Rouen,
3 Hôpitaux Universitaires de Strasbourg,
4 CH Marne la Vallée Creation of an auditing tool for an aseptic preparation unit according to the french good preparation practices (GPP) - Assessment of a chemotherapy preparation unit Lucie Baillet1, Latifa Haddad1, Michèle Vasseur1, Christophe Berneron1, Amandine Menet2, Christophe Lestrez3, Bertrand Decaudini1, Pascal Odou1 1 Institut de pharmacie, CHRU Lille, France
2 Ingénieur qualité, CHRU Lille, France
3 Ingénieur responsable de la qualité de l’air, CHRU Lille, France Qualification of new pharmacotechnical operators A. Venet, M. Grouvel, C. Bedoucha, B. Roussely, A. Jourand Unité de préparation stérile - pharmacie,
CHU de Bordeaux Groupe Hospitalier Pellegrin,
Application of educational films for staff training in parenteral nutrition unit P. Legrand, J. Bordenave, C. Cambier, F. Nadji, G. Benoit Pharmacie, Hôpital Armand Trousseau AP-HP / HUEP,
26 avenue du Docteur-Arnold-Netter
75571 Paris cedex 12, France Pharmacy technicians education: an innovative pedagogical tool L. Danguy des Déserts, C. Nowak, I. Baudin Centre Hospitalier d’Angoulême
Hand’s microbiocontamination in Cytotoxic Reconstitution Unit (CRU) R. Picot-Guéraud1, C. Fayard1, N. Sylvoz1, I. Federspiel1, A. Lemoigne1, L. Foroni1, P. Saviuc2, M-R. Mallaret2 CHU de Grenoble, France.
1 : Pôle Pharmacie,
2 : Unité d’Hygiène Hospitalière
Workshops
Workshop 2: Distribution channel of injectable preparations from pharmacy to patient
Moderators: M.L. Brandely, I. Roland
Workshop 3: Dose standardisation of cytotoxics
Moderators : L. Escalup, G. Podilsky, N. Jourdan
Workshop 4: Validation of a training program for the operators in the preparation of injectable drugs in a zone with controlled atmosphere
Moderators : Y. Huon, CHU de Liège - P. Rohrbach, CH Verdun - J.M. Canonge, CHU Toulouse