Contaminated LVPs and the Origins of Validation - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Contaminated LVPs and the Origins of Validation
Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.

Pharmaceutical Technology

3. FDA, "Human Drugs—Current Good Manufacturing Practice in Manufacture, Processing, Packing or Holding of Large Volume Parenterals, and Request for Comments Regarding Small Volume Parenterals," Fed. Regis. 40 (106), 22202–22208 (June 1, 1976).

4. "Epidemiological Notes and Reports: Septicemias Associated with Contaminated Intravenous Solutions—Wisconsin, Ohio," Morbidity and Mortality Weekly Report (Center for Disease Control, Atlanta, GA, Mar. 17, 1973) pp. 99.

5. FDA, Guideline On General Principles Of Process Validation (Food and Drug Administration, Rockville, MD, May 1987).

6. X. Mao, "Energy Saving Tips for Desiging Air Handling Units (AHUs) in Cleanrooms," Pharm. Eng. 26 (2), 1–5 (2006).

7. W. Garvey, "Essentials of Validation Project Management, Part 1," Pharma. Technol. 29 (12), 68–76 (2005).

8. W. Garvey, "Essentials of Validation Project Management: Part 2," Pharma. Technol. 30 (1), 72–86 (2006).

9. EC, Guide to Good Manufacturing Practice Revision to Annex 1, Manufacture of Sterile Medicinal Products (European Commission, Brussels, Belgium, May 2003).

10. ISO 14644-1: Cleanrooms and Associated Controlled Environments-Part:1 Classification of Air Cleanliness (International Organization for Standardization, Geneva, Switzerland, 1999).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here