Application of a Risk-Based Approach in the Development and Use of a Monitoring System in a Pharmaceutical Rubber Manufacturing Plant.

Carina Van Eester

Helvoet Pharma
Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium
Tel: +32 1159 0854  Fax: +32 1159 0941

Biography

Carina Van Eester graduated as an industrial engineer chemistry.  After finishing her studies she joined the R&D packaging development at Procter and Gamble.  In 1992 she joined Janssen Pharmaceutica in Belgium, where she was first responsible for incoming inspection of packaging materials and later became a packaging development engineer.  In 2001 she worked for 2 years at PriceWaterhouseCoopers as consultant in computer validation.  After that, she joined Pfizer where she worked for 4 years as a lead engineer in the Pharmaceutical Technical Support.  In 2007, she joined Helvoet Pharma in Belgium where she works as a technical support manager in the R&D and Technical Support department.

Company Profile

Helvoet Pharma is the world’s second largest manufacturer of elastomeric closures and aluminium and aluminium/plastic caps for pharmaceutical applications.

Abstract

Risk based approach was introduced by the FDA in Sept 2004 “Pharmaceutical cGMPs for the 21st Century – A risk based approach – final report” and by the ISO 15378 in March 2006 : “Primary packaging in medicinal products – particular requirement for the application of ISO 9001:2000, with reference to GMP”.

By these standards, manufacturers of packaging materials for the pharmaceutical industry are encouraged to include an effective management of the risks associated with the design, development and manufacturing of primary packaging materials.

For the introduction of the next FirstLine™ concept, Helvoet Pharma has taken the opportunity to implement the risk-based approach.  All systems used during the manufacturing of a rubber component have been assessed by performing a FMEA (Failure Mode and Effect Analysis) : risks are identified per system and evaluated for probability and severity.  This results in a risk number.  For all elements with a high risk number, an inherent safety by design is preferred.  However, this is not always possible.  The second option in risk controlling is to implement a measuring system to detect the weaknesses.  This will enable to act already during processing of the goods.  The last option is to control residual risk by SOP’s, In- Process Control and final inspection.