Particulate Quality of Single-Use Filling Systems - The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabiliti

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Particulate Quality of Single-Use Filling Systems
The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.


BioPharm International
Volume 24, Issue 7, pp. 20-24

REFERENCES

1. USP 34–NF 29 General Chapter <1>, "Injections."

2. USP 34–NF 29 General Chapter <788>, "Particulate Matter in Injections."

3. EurPh, 5.0, 2.9.19 "Particulate Contamination: Sub-Visible Particles" (EDQM, Strasbourg, France, 2005), 253–255.

4. Japan Pharmacopoeia XV, 6.06, "Foreign Insoluble Matter Test for Injectables," in General Tests, Processes, and Apparatuses Section, p. 110–113.

5. ICH, Q4B, Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions — Annex 3 Test for Particulate Contamination: Subvisible Particles, General Chapter (Jan. 2009).

6. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington DC), Part 211.65, "Equipment."

7. EurPh, 5.0, 2.9.20, "Particulate Contamination: Visible Particles" (EDQM, Strasbourg, France, 2005) 255–256.

8. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 211.72 "Filters."


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