Draft Guidance Issued for Injectors Development - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Draft Guidance Issued for Injectors Development

Equipment and Processing Report

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a draft guidance for industry titled Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product.

Depending on the system and its applications, these elements may fall under various regulatory provisions such as 21 CFR 3.2(e) or 510(k). The document discusses the scientific and technical considerations that may be relevant when developing these systems, regardless of the regulatory provisions that apply.

The draft guidance discusses design features as well as general use, conditions of use (e.g., personal use, use by healthcare professional, and disposable or reusable products), and injector materials used to construct or manufacture each device. The document provides a list of the various performance testing standards (ISO and ASTM) that are recommended and discusses separate tests such as biocompatibility, dose accuracy, shelf-life stability, and expiration dating. Sterilization and sterility testing is also discussed in detail.

A copy of the draft guidance can be downloaded for the purposes of providing a comment.

See related PharmTech articles:

S. Sutton, EPT, Prefilled Syringes Growing More Popular

N. Motlekar, Online Exclusive, Designing and Delivering Therapeutic Proteins

B. Harrison and M. Rios, May 2007, Big Shot: Developments in Prefilled Syringes

D. McCormick, Oct. 2006, Developing First Disposable Injector for a Biopharmaceutical



blog comments powered by Disqus
LCGC E-mail Newsletters

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

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Equipment and Processing Report,
Click here