Drug manufacturing is an ultra-sterile process. Numerous regulations need to be complied with when pharmaceuticals are sold worldwide, as is the case at this Belgian plant, where a global pharmaceutical company makes cardiac and cancer drugs – naturally under optimally sterile conditions. Even taking photos for this article inside the cleanroom – which is still in its test and startup phase – was a complicated process. But let’s start at the beginning.
Automatisation for a mobil cleanroom
Location: Belgium
Industry: Pharma industry
Application: Cleanroom
- software, controller and converter to the drive and energy transfer systems needs to come from a single source
- an existing plant be extended and integrated
- FA57BCMPZ71S parallel-shaft helical servo gearmotor and the KA57BCMPZ71S helical-bevel servo gearmotor
- FA37BCMP63M parallel-shaft helical servo gearmotor
- four KA19CMP50S helical-bevel servo gearmotors
- software, controller and converter to the drive and energy transfer systems needs to come from a single source
- an existing plant be extended and integrated
Drug manufacturing needs to meet high standards. In addition to the requirements of the FDA (Foods and Drugs Administration) in the USA, manufacturing directives also exist in Europe (European Commission) and at international level (ICH – International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
This particular pharmaceutical company naturally follows the relevant regulations while also complying with cGMP (current Good Manufacturing Practice) – a U.S. method for verifying current quality standards in manufacturing. There is also an equivalent in the European Union – the EU GMP guideline (Directive 2003/94/EC), which defines good manufacturing practice for drugs for human use.
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