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TABLE 1 Directives of the European Union
Directive 90/219 EEC on the contained use of genetically modified micro-organisms
Directive 90/220 on the deliberate release of genetically modified micro-organisms
Directive 90/679 on the protection of workers from risks related to exposure to biological agents
at work
vessels, centrifuges should be equipped with spray balls to rinse the entireinner
surface. Alot moredesign criteria could be mentioned but other chapters of this
book deals with this topic in detail.
& The surface of the production equipment must not affect the quality of the
product. The material has to be a chemical resistant against process and
cleaning agents. Stainless steels are first choice. If not applicable plastics are
an alternative. Authorities give good advice that amaterial doesn’t affect the
product quality.
& Cleanability of process equipment will be verified through cleaning validation.
In case different equipment can be connected with the same CIP circuit, the
equipment has to be appropriately identified. Preventing mix up of equipment can
be achieved by manually or automatically labeling the equipment. Because most
facilities have to manage alot of equipment, asystem to create an individual
number for each item should be established.
The cleanliness status of the equipment has to be identified. The aim is to
prevent using contaminated equipment for manufacturing. This can be achieved by
removable labels or by electronic status management if using automated
control systems.
Closed or contained equipment should be used for cleaned-in place process as
well as for CIP equipment. This is important to prevent contamination from the
environment. When designing cleaned-in place process equipment fix installed
spray balls, closed CIP supply and return loops are afew interesting possibilities.
The above discussion includes the most important points to be considered for
design and maintenance of aCIP system to fulfill the GMP requirements and to
comply with the performance criteria as set in the GMP.
EUROPEAN STANDARDS FOR BIOTECHNOLOGY
The EuropeanCommission mandated the European Committee for Standardization
Comité Européen de Normalisation (CEN) to develop standards, which support the
existing and future legislation and specifically those directives, which are
concerned directly with Biotechnology (17) (Table 1). Furthermore, they should
facilitate and guarantee compliance with the legal requirements at technical level.
The standards should define in concrete terms the technical specifications, codes,
methods of analysis, etc., and such establish fundamentals for the basic requirements
of the directives for safety, environmental and workers protection (18).
TABLE 2 Working Groups of European Institute for Normation (CEN)
Killinger and Höller
WG 1 Research, development and microbial analysis in laboratories
WG 2 Large scale process and production
WG 3 Modified organisms for application in the environment
WG 4 Guidance on testing procedures
Performace criteria for equipment