Microbiological control for processing of blood

Česká verze

Authors: M. Czirfuszová ¹; D. Matušová ²; M. Širicová ³
Authors place of work: HPL spol. s r. o., oddelenie farmaceutického skúšania, Komárno ¹; Spracovateľské centrum NTS SR, Bratislava ²; Hlavný manažér kvality NTS SR ³
Published in the journal: Transfuze Hematol. dnes,19, 2013, No. 3, p. 180-184.
Category: Souhrnné práce, původní práce, kazuistiky

Summary

The system of quality assurance of blood products is set up in such a way as to guarantee product safety and microbiological purity. Microbiological control of all processes during the manufacture of blood products serves to verify the functionality of this quality control system. The authors provide an overview of the legislative requirements for ensuring quality control of blood products, the requirements for control laboratories and they present a short overview of the activities of a control laboratory and the findings of bacterial contaminants in blood products and the manufacturing environment in the years 2011 and 2012.

Key words:
blood products, control of environment, sterility, control laboratory, bacterial contamination

Zdroje

1. Vyhláška MZSR č. 487/2006 Z. z. z 26.júla 2006 o požiadavkách na sledovanie krvi, zložiek z krvi a transfúznych liekov, na formu a spôsob oznamovania závažných nežiaducich reakcií a závažných nežiaducich udalostí a na vyhodnocovanie ich príčin a na normy a špecifikácie súvisiace so systémom kvality v transfúziologických zariadeniach. Dostupné na internete: http://www.sukl.sk/buxus/docs/Bezpecnost_liekov/Krv/VyhlMZ_487_2006_Sledovanie_krvi_transf_liekov_2006.pdf

2. Vyhláška MZSR č. 333/2005 Z. z. z 6. júla 2005 o požiadavkách na správnu prax prípravy transfúznych liekov. Dostupné na internete: http://www.sukl.sk/buxus/docs/Inspekcia/Legislativa/VyhlMZ_333_2005_transfuzne_lieky.pdf

3. European Pharmacopoeia 7th edition, supl. 7.8, Strasbourg: European Directorate for the Quality of Medicines & HealthCare, 2013; čl. 3.1, 3.2.3, 3.2.4, 3.2.5, 3.2.6., ISBN/ISSN: 978-92-871-7224-2

4. EudraLex, The rules governing medicinal products in the European Union, Volume 4, EU guidelines to Good Manufacturing Practice medicinal products for human and veterinary use, Annex 1, Manufacture of sterile medicinal products, Bruxelles : Commission Européenne, 2008. Dostupné na internete: http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf

5. Metodický pokyn MP 117/2012 Postup pre udelenie rozhodnutia o schválení laboratória vykonávajúceho farmaceutické skúšanie pre výrobcov liekov. ŠÚKL RD-06, 2012. Dostupné na internete: http://www.sukl.sk/buxus/docs/Inspekcia/SVP/MP 117_2012.pdf

6. European Pharmacopoeia 7th edition, supl. 7.8, Strasbourg: European Directorate for the Quality of Medicines & HealthCare, 2013; čl. 2.6.1, ISBN/ISSN: 978-92-871-7224-2

7. European Pharmacopoeia 7th edition, supl. 7.8, Strasbourg: European Directorate for the Quality of Medicines & HealthCare, 2013; čl. 2.6.27, ISBN/ISSN: 978-92-871-7224-2

8. McDonald C P, Lowe P, Roy A, et al. Evaluation of donor arm disinfection techniques. Vox Sanguinis 2001; 80: 135–141.

9. Nakamura A, Abe K, Masuya M, et al. Efficiency of diversion of the first aliquot of blood and prestorage leukoreduction for preventing bacterial contamination in red blood cell concentrates assessed using a rapid polymerase chain reaction-based bacterial detection system. Transfusion Medicine 2011; 21: 365–370.

10. Kunishima S, Inoue C, Kamiya T, Ozawa K. Presence of Propionibacterium acnes in blood components. Transfusion 2001; 41: 1126–1129.

11. Soeterboek A M, Welle F H, Marcelis J H, van der Loop C M. Sterility testing of blood products in 1994/1995 by three cooperating blood banks in the Netherlands. Vox Sanguinis 1997; 72: 61–62.

12. Brecher M E, Hay S N. Bacterial contamination of blood components. Clin. Microbiol. Rev., January 2005; vol. 18, no. 1 : 195-204.

13. Schrezenmeier H, Walther-Wenke G, Müller T H, et al. Bacterial contamination of platelet concentrates: results of a prospective multicenter study comparing pooled whole blood–derived platelets and apheresis platelets. Transfusion 2007; 47: 644–652.

14. Hillyer Ch D, Josephson C D, Blajchman M A, et al. Bacterial Con-tamination of Blood Components: Risks, Strategies, and Regulation. ASH Education Book 2003; vol. 2003, no. 1 : 575-589.

15. Jacobs J, Jamaer D, Vandeven J, et al. Yersinia enetrocolitica in donor blood: a case report and review. Journal of Clinical Microbiology 1989; vol. 27, no. 5 : 1119-1121.

16. Arduino M J, Bland L A, Tipple M A, et al. Growth and endotoxin production of Yersinia enterocolitica and Enterobacter agglomerans in packed erytrocytes. Journal of Clinical Microbiology 1989; vol. 27, no. 7 : 1483-1485.