Silicone Microdroplets in Protein Formulations—Detection and Enumeration - Pharmaceutical Technology

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Silicone Microdroplets in Protein Formulations—Detection and Enumeration
The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

Pharmaceutical Technology
Volume 33, Issue 1


1. E.J. Smith et al., "Siliconization of Parenteral Drug Packaging Components," J. Parent. Sci. Technol. 42 (Supplement 4S), S1–S13 (1988).

2. S. Branley, "Chemistry and Properties of Medical Grade Silicones," J. Macromol. Sci. Chem A. 4 (3), 529–544 (1970).

3. E.A. Chantelau, "Silicone Oil Contamination of Insulin," Diabet. Med. 6 (3), 278 (1989). ]

4. R.K. Bernstein, "Clouding and Deactivation of Clear (Regular) Human Insulin: Association with Silicone Oil from Disposable Syringes," Diabetes Care 10 (6), 786–787 (1987).

5. R.N. Baldwin, "Contamination of Insulin by Silicone Oil: A Potential Hazard of Plastic Insulin Syringes," Diabet. Med. 5 (8), 789–790 (1988).

6. G.L. Shearer, "Contaminant Identification in Pharmaceutical Products," The Microscope 51 (1), 3–10 (2003).

7. L. S. Jones et al., "Silicone Oil Induced Aggregation of Proteins," J. Pharm. Sci. 94 (4), 918–927 (2005).

8. USP 29–NF 24 (suppl 2) General Chapter <788>, "Particulate Matter in Injections." US Pharmacopeial Convention, Rockville, MD, 2006.

9. "Particulate Contamination: Visible Particles" in European Pharmacopoeia, (European Pharmacopoeia Commission, Council of Europe, European Department for the Quality of Medicines, 2005) 5th ed. Vol. 5.0 (incl. suppl 5.1). General Chapter 2.9.20.

10. "Foreign Insoluble Particulate Matter Test for Injections" in Japanese Pharmacopoeia (Society of Japanese Pharmacopoeia, 2006) 14th edn. General Chapter 20.

11. D.K. Sharma et al., "Flow Microscopy for Particulate Analysis in Parenteral and Pharmaceutical Fluids," European J. Parent. Pharma. Sci. 12 (4), 97–101 (2007).


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