Packaging Material Qualification

Helen Brown

AstraZeneca R&D Charnwood
Bakewell Road, Loughborough, LB11 5RH Leicestershire, United Kingdom
Tel: +44. 1509 645 065   Fax: +44. 1509 645 546

Email: Helen.c.brown@astrazeneca.com

 

  

 

  
 

Biography

Helen Brown has twenty years of work experience within the Pharmaceutical Industry.  This ranges from analytical chemistry, formulation studies and packaging/ device development.

She studied Chemistry at degree level, is a diploma member of the Institute of Packaging then went on to obtain an MSc in Pharmaceutical Sciences.  She is currently studying for a PhD in Biomaterials at Nottingham University.

Helen currently looks after early to late phase development packaging in the UK, Sweden and US.  She is also responsible for the materials qualification for medical devices.

Company Profile

AstraZeneca is one of the world’s leading Pharmaceutical companies which is active over 100 countries.  Over 65,000 people are employed across Europe, in the Americas, Asia, Africa and Australasia.  AstraZeneca operates in six major therapeutic areas of healthcare: cancer, cardiovascular, gastrointestinal, infection, neuroscience and respiratory and inflammation. Key products include Arimidex, Crestor Losec, Nexium, Seroquel and Symbicort. 

 

 

   
 

 

Abstract

Packaging is used for many dosage forms ranging from solid dose, parenterals, steriles and oral solutions or suspensions, opthalmics and medical devices. 

Material qualification is vital for all packaging componentry to ensure the best pack is used to deliver a highly regulated medicinal product.

Qualification covers many areas.  This presentation will cover a range of these to give an overview of what is involved when choosing a pack.  Topics will include:

  • Specifications – user requirements, visual, dimensional and functional testing.
  • Supplier audits – importance of this and guidance
  • Regulatory compliance  -Pharmacopoeial, Code of Federal Regulations
  • BSE/TSE compliance – what should be considered
  • Environmental considerations - Directives
  • Compatibility studies – extractables and leachables
  • Equivalence testing – to be considered if supplier/ material is changed

Additional testing – moisture vapour transmission rates (MVTR), desiccant absorption capacities.