An extractables/leachables strategy facilitated by collaboration between drug product vendors and plastic material/system suppliers

PDA Journal of Pharmaceutical Science and Technology

Volumn 61, Issue 1, 2007, Pages 17-23

  Jenke, Dennis ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Extractables; Leachables; Vendor qualification

Indexed keywords

DRUG; PLASTIC;

CONTAINER; DRUG INDUSTRY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SOLUTION; LEACHING; RESPONSIBILITY; REVIEW;

CHEMICAL INDUSTRY; CONSUMER PRODUCT SAFETY; DRUG INDUSTRY; DRUG PACKAGING; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; INFORMATION DISSEMINATION; INTERDISCIPLINARY COMMUNICATION; PLASTICS;

EID: 33847624968     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Nasal Spray Drug Products-Chemistry, Manufacturing and Controls Documentation. Section III.G. FDA: Rockville, MD, 2002.
2. Food and Drug Administration, Center for Drug Evaluation and Research. Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder (DPI) Drug Products-Chemistry, Manufacturing and Controls Documentation. Section III.G. FDA: Rockville, MD, 1998.
3. European Medicines Agency. EMEA/CVMP/205/04. Guideline on Plastic Immediate Packaging Materials. May 19, 2005.
4. Association for the Advancement of Medical Instrumentation (AAMI). ISO/FDIS 10993-17:2002. Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limits for Leachables Substances. November 27, 2002.
5. Norwood, D. L.; Nagao, L.; Lyapustina, S.; Munos, M. Application of modern analytical technologies to the identification of extractables and leachables. Am. Pharm. Rev. 2005, 78, 80, 82-87 .
6. Jenke, D. R. Nomenclature associated with the chemical characterization of, and compatibility evaluations for, medical product delivery systems. PDA J. Pharm. Sci. Technol. 2003, 57 (2), 97-108.
7. Jenke, D. R. Linking extractables and leachables in container/closure applications. PDA J. Pharm. Sci. Technol. 2005, 59 (4), 265-281.
8. Hansen, K. J. Developing a correlation between extractables & leachables in MDIs and DPIs. Drug Delivery Technology 2005, 5, 66-68.