Containment Systems under Discussion

GMP News No. 704

GMP News
11 April 2006
 

Containment Systems under Discussion

 
The need for contained handling and processing of pharmaceuticals started to rise significantly about 15 years ago. Reasons were an increased focus on health and safety aspects and also the development of more potent active ingredients. 

The introduction of split valve systems improved the containment possibilities significantly. Over the following years, containment systems often needed to fulfil special requirements, such as resistance towards organic solvents, steam, high temperatures or vacuum. 

This resulted in the development of highly sophisticated systems, some of which assured the protection of the product against contamination from the environment in addition to the requirements described above. With a rising number of systems in the market, it became obvious that it is always important to choose an appropriate system. 

Additionally today most often not only the toxicity of the active is taken into consideration, but also factors like its dilution with excipients or number and duration of critical operation steps per shift. 

However, not all questions concerning the handling and use of containment systems have been answered. Some of the points on which there will be a controversial discussion also in the future are:

  • Exposition in the use of certain technologies/systems/equipment
  • Equipment design from the point of view of staff health protection
  • Surface limits
  • Multi-purpose versus mono-suites - what is recommended?
  • Is dilution the solution?
  • Automation and PAT: A must in containment?
The answers to these and further discussion points will be provided at the event Containment – With a guided tour of AstraZeneca, Plankstadt organised by the European Compliance Academy (ECA) in Heidelberg, Germany, on 9 and 10 May 2006.

In this comprehensive course, attendees get to know how to select the optimal containment system based on the toxicological characteristics of a drug and the production process requirements of the process. This is assured by lectures of well-known experts explaining the underlying fundamentals plus case studies from the industry. 

A guided tour of AstraZeneca's facility in Plankstadt rounds the seminar off.

The production unit of AstraZeneca Plankstadt was designed specifically for high-potency products. By means of the implemented Process Analytical Technology (PAT) tools, all in-process controls can be conducted online without breaking the containment. In this manner, a maximum staff protection is ensured.

 
Author:
Harald Martin
On behalf of the European Compliance Academy
 

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