14-Jan-2011

Contamination control – crucial training for the life science sector

Between 1995 and 2005, the potential risk of microbiological contamination was the top major GMP deficiency observed during inspections requested by the CHMP/CVMP of EMA.

Its importance is also shown in current changes in guidelines such as:

  • USP chapter <1116> – “Microbiological Evaluation of Clean Rooms and Other Controlled Environments”
  • the new draft of ISO 14644-9 "Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle contamination"

and the revision of ISO 14644 parts 1 and 2 namely:

  • ISO 14644-1 Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness by particle concentration
  • ISO 14644-2 Cleanrooms and associated controlled environments: Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1

Specified dedicated programmes and qualified and validated processes for environmental monitoring and trending of the evaluated data are essential steps for fulfilling the quality requirements for medicinal products. Furthermore, preventative measures like cleaning and disinfecting of surfaces, room decontamination and the different parts of staff hygiene like gowning and dress code are important parts of contamination control.

Against the background of these requirements the ECA education course Contamination Control, to be held in Prague, Czech Republic, from 29 – 31 March 2011, is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.

This course addresses associates from life science industries who are involved in:

  • Microbial monitoring
  • Implementation of hygiene programmes
  • Selection and qualification of disinfectants
  • Handling of microbial deviations
  • Training of operators for monitoring and sanitising measures

The European Compliance Academy (ECA), is an independent membership association and is the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. It has close to 4,000 members representing more than 60 countries.

The organisation is offering a preferential rate to Cleanroom Technology readers and visitors. Register for the course Contamination Control with the code ct2011 and you will receive a €100 rebate on the registration fee. Please make sure to mention the code in the Comment field.

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