Overview

This course will give participants an understanding of how polymeric materials are used in pharmaceutical products and how additives and other materials related to those polymers i.e. the extractables and leachables, may be of concern or risk to the patient. 

The course will also cover the regulatory aspects and requirements relating to E & L, and will highlight some of the guidelines developed to assist medical companies in defining strategy and limits for testing. 

Analytical methodology, instrumentation and sample preparation will be discussed and the basic steps required for performing an E & L study will be described, including  stability plans and method validation. Case studies will be used to demonstrate the processes involved.


Who will benefit from attending?

• Pharmaceutical Companies - R & D Groups; analysts; managers; packaging consultants; regulatory affairs personnel.  All personnel who have responsibility for contributing to the regulatory submission package.
• Medical Device Manufacturers involved in primary packaging for drugs and drug delivery systems - product and packaging designers, packaging consultants, quality assurance personnel
• Manufacturers of components for Medical Devices
• Plastics Moulders considering diversifications into medical device manufacture
• secondary packaging manufacturers (e.g. labels, foil overwraps) whose products need to comply with extractables regulations.

Course Objectives

Participants will receive the information to be able to:

• understand exactly what information can be gained from the various tests
• decide whether E & L tests are necessary for their products, in consideration of legislation and best practice guidelines
• make the best use of the informaton obtained from test results

Course Content
 

Background to Polymers

• Discussion of polymeric and elastomeric materials available for use, and where and why the various polymers are used.
• Polymer additives, potential impurities and the reasons for their presence.
• Review of polymer processing

  
Regulations and Guidelines    

• Why we are interested in extractable and leachables
• Why we have to test for extractable and leachables
• Regulatory standpoints and requirements
• Working groups and guidance documents

Introduction to Extractable and Leachables

• Definition of extractables and leachables
• How extractable compounds become leachables
• Factors affecting the migration of compounds

 
Analytical Techniques & Approaches:

• Component review & selection of critical parts
• Aim of extractable study
• Extraction methods, including solvent choice and sample preparation techniques.
• Analytical techniques overview:

o gas chromatography mass spectrometry (GC-MS)
o liquid chromatography mass spectrometry (LC-MS/UV)
o non volatile residue (NVR)
o Fourier transform infra spectroscopy (FT-IR)
o Inductively coupled plasma atomic emission spectroscopy (ICP-AES).
o Extractable study case studies
o Laboratory tour

Leachable Method Development & Validation

• Leachable method development:

o Selection of extractable / leachable compounds
o Development of leachable analytical methods

• Leachable method validation:

o Aim
o Guidance / standard review
o Validation parameters discussion
o How to execute validation
o Validation case studies

• Leachable studies:

o Stability storage overview
o Leachable time point analysis

Course Presenters:

Tim Hulme, Principal Pharmaceutical Consultant, Smithers Rapra, Dr. Andrew Feilden, Principal Consultant, Smithers Rapra, Michael Creese, Senior Consultant , Smithers Rapra, Donna Howells, Senior Consultant, Smithers Rapra, Helen Lewis, Senior Consultant, Smithers Rapra.

 Extractables and Leachables Testing at Smithers Rapra:

The examination of extractables & leachables from primary packaging of drug delivery devices is growing in importance due to regulatory requirements from organisations such as the FDA. These regulations are concerned with various drug delivery devices, such as meter dose & dry powder inhalers (MDI & DPI), & cover a wide range of aspects including extractables & leachables from elastomeric & plastic components of the primary packaging.

Smithers Rapra   http://www.rapra.net/contact.asp   have  considerable experience working for a wide client base, often in support of their own in-house laboratory facilities. The test results & data have been used to support successful regulatory submissions to both the FDA & EMEA.