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

ADVERTISEMENT

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."


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Report Predicts Generics Production Return to US
August 15, 2014
Author Guidelines
Source: BioPharm International,
Click here