Glass delamination and breakage

BioProcess International

Volumn 9, Issue 11, 2011, Pages 52-57

  Reynolds, Graham ^a   Paskiet, Diane ^a  

^a West Pharmaceutical Services Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLASS; GLUCONATE CALCIUM; POLYMER; SILICONE;

ARTICLE; CHROMATOGRAPHY; CONTAINER; GLASS BOTTLE; GLASS INDUSTRY; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; RISK;

EID: 83755178100     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (11)

1. Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics. IPQ in the News 7 August 2011.
2. American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates. US Food and Drug Administration: Rockville, MD, 18 July 2011; www.fda.gov/Safety/Recalls/ucm263531.htm.
3. American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates. US Food and Drug Administration: Rockville, MD, 15 June 2011; www.fda.gov/Safety/Recalls/ucm259312.htm.
4. American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates. US Food and Drug Administration: Rockville, MD, 6 June 2011; www.fda.gov/Safety/Recalls/ ucm258064.htm.
5. Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs. US Food and Drug Administration: Rockville, MD, 25 March 2011; www.fda.gov/Drugs/DrugSafety/ucm248490.htm.
6. Pharma 2020: Supplying the Future. PricewaterhouseCoopers: New York, NY, February 2011; www.pwc.com/gx/en/pharma-life-sciences/pharma-2020/pharma-2020- supplying-the-future.jhtml.
7. Cummings K. A History of Glass Forming. University of Pennsylvania Press: Philadelphia, PA, 2002.
8. Control of Components and Drug Product Containers and Closures. US Code Fed. Reg. Title 21, Part 211.94(a) Subpart E. US Food and Drug Administration: Rockville, MD, 1 April 2011.
9. CDER/CBER. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics - Chemistry, Manufacturing, and Controls Documentation. US Food and Drug Administration: Rockville, MD, April 1999; www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070551.pdf.
10. Niles WD, Coassins PJ. Cyclic Olefin Polymers: Innovative Materials for High-Density Well Plates. Assay Drug Develop. Technol. 6(4) 2008: 577-590
11. Waxman L, Vilivalam V. Evaluation of End-Over-End Rotation/Agitation of Protein Solutions in Prefilled Syringes Made from Glass or Plastic as a Preliminary Indicator of Protein Aggregation. 2011 Colorado Protein Stability Conference, 19-21 July 2011, Breckenridge, CO.