Assessing Filling Technologies For Contamination Risk - The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies. -

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Assessing Filling Technologies For Contamination Risk
The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.


BioPharm International
Volume 25, Issue 3, pp. 46-58

REFERENCES

1. M. Haag, Pharm. Tech. Eur. 23 (3), 38–41 (2011).

2. B. Verjans, J. Thilly, and C. Vandecasserie, Aseptic Processing Supplement to Pharm. Tech. 29, S24–S29 (2005).

3. International Organization for Standardization, ISO 8362-1:2009, Injection containers and accessories - Part 1: Injection vials made of glass tubing.

4. International Organization for Standardization, DIN ISO 11040–4:2007, Prefilled syringes - Part 4: Glass barrels for injectables.

5. International Organization for Standardization, DIN ISO 9187–1:2010, Injection equipment for medical use - Part 1: Ampoules for injectables.

6. C. Reed, "Recent Technical Advancements in Blow-Fill-Seal Technology," in Business Briefing: Pharmagenerics, (World Markets Research Centre, 2002) pp 1–4.

7. International Organization for Standardization, DIN ISO 14644-1:1999, Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness.

8. Eudralex, Volume 4, Annex 1 (corrected version): Manufacture of Sterile Medicinal Products (2008).

9. J. Ziemermann, presentation at ISPE Tampa Conference (Tampa, FL, 2006).

10. C.S. Sinclair and A. Tallentire, "Predictive sterility assurance for aseptic processing," in Sterilization of Medical Products VI, R. F. Morrisey, Ed., (Polyscience Publ., Montreal 1993), pp 97–114.

11. C. S. Sinclair, and A. Tallentire, J. Pharm. Sci. Technol. 49 (6), 294 (1995).

12. R.P. Vonberg and P. Gastmeier, J. Hosp. Infect. 65, 15–23 (2007).

13. M. Klevens et al., Public Health Reports 122 (2), 160–166 (2007).

14. R. Runas, Pharmaceutical Engineering, 31 (3), 72–75 (2011).


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