Article 5.2.2.13.3.

The establishment consists of a clean section and an unclean section, which are kept separate in a suitable manner to prevent pollution or repollution of the finished products. The unclean section consists of the area for storing the untreated waste materials and the decontamination equipment. The clean section contains the storage of substances that have passed through the decontamination phase.


Infectious waste materials are processed as quickly as possible, and at least weekly. The processing frequency is matched to the storage capacity of the area where the waste is stored while awaiting decontamination.


Gases and vapours are passed through a HEPA filter before being emitted by the installation.


The decontamination installation meets the provisions of appendix 5.2.2.13.C.


The monitoring of the decontamination installation meets the provisions of appendix 5.2.2.13.C.


The recorded data are classified and kept available for perusal by the supervisor for two years.


The measuring equipment is regularly calibrated by the body or person responsible for maintenance. In case of abnormal operating conditions, precautions are taken in accordance with appendix 5.2.2.13.C.