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. -

ADVERTISEMENT

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).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Novartis and GSK Trade Assets
April 22, 2014
Lilly to Acquire Novartis Animal Health
April 22, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here