Subsection 5.2.2.13.
Establishments for the storage and moist-heat treatment of infectious waste materials

Translation not available

Article 5.2.2.13.1. Translation not available

Article 5.2.2.13.2.

The decontamination installation is built, equipped and operated such that the waste materials are decontaminated as uniformly and completely as possible using moist heat. Techniques that work with dry heat are not permitted.


The conditions for temperature and pressure are described in appendix 5.2.2.13.A and 5.2.2.13.B.

The operating pressure of the equipment is adapted to the operating temperature, thereby ensuring at all times that the generated steam is saturated. The decontamination phase starts when the specified temperature and pressure are reached.


Only if all the provisions of the code of good practice specified in appendix 5.2.2.13.C are complied with can the decontamination be considered adequate.


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.


Article 5.2.2.13.4.

The decontamination installation includes a maintenance programme and a maintenance protocol that at least contain the maintenance operations of appendix 5.2.2.13.C.


The decontamination installation is documented in a logbook that at least contains the information specified in appendix 5.2.2.13.C.


The process parameters that are recorded for each decontamination cycle and the results of the maintenance programme are kept available for perusal by the supervisor for at least two years.


Article 5.2.2.13.5.

1.

The installation must pass the following inspections:

1

through an inspection at the time of commissioning, the operator shows that the installation operates according to the predetermined process parameters, the recording equipment has been correctly calibrated and there is adequate killing of pathogenic and/or genetically modified micro-organisms;

2

via a periodic inspection, the operator shows that the installation is still able to guarantee adequate killing of pathogenic and/or genetically modified micro-organisms. This inspection is initially carried out monthly. After a period of twelve months in which all monthly inspections deliver a favourable result, the inspection is carried out every three months;

3

following events that could affect the proper functioning of the installation, it is demonstrated by means of an exceptional inspection that this proper functioning remains guaranteed. This is done in any case after a repair, a malfunction and upon any significant change in the waste to be processed.


For the test-organism of biological indicators, traces are used of Bacillus subtilis, Geobacillus stearothermophilus or another organism that can be shown to have at least an equivalent resistance to decontamination with moist steam.

2.

The reports of the prototype inspection, the inspection on commissioning and the protocols for periodic and exceptional inspections are validated by the technical expert. The validations are requested by the operator of the installation and are carried out at his/her expense.


These documents and the validation document are kept available for perusal by the supervisor.

The reports of the periodic and exceptional inspections, together with the logbook of maintenance, repairs and loading, are kept available in the installation for perusal by the supervisor for two years.


Article 5.2.2.13.6. Dangerous medical waste that has passed through a decontamination cycle is only released as solid non-dangerous medical waste materials if the recorded process parameters have been checked by the person responsible for the decontamination. For this he/she signs a release form that can be produced at the request of the registered collector. If the process parameters or the results of the biological inspection after the process differ from the regulations, the waste materials are treated as dangerous medical waste materials.

Article 5.2.2.13.7. Preventive measures for employees are taken in accordance with appendix 5.2.2.13.C.