1. Samuel Vidal Vetagro Sup – Lyon – France Samuel.vidal@vetagro-sup.fr www.afstal.com

2. Most of the requirements for installation and equipments were already existing in the Directive 86/609/EEC.  Hygiene, disinfection  Separated areas for each activity  Control of physical environment :  Temperature  Relative Humidity  Ventilation They were expressed with precise guidelines taken from the European Convention STE 123, Annex A. A new version of this annex A was published in June 2006. First, it was considered as optional but now it is included in the Directive and is relevant and compulsory in 2017 for all enclosure and cages sizes.

3. In the Directive 2010/63/UE, most of in formations can be found in annex III (transposition of annex A of ETS 123). It is different from the 1986 version : - larger enclosures - evidence based – gives the aim of the requirements. The inspection has to assess the efficacy of each measure.

4.  Constructed as to provide an environment adapted to physiological and ethological needs of species  To prevent access by unauthorized people  To prevent escape of animals  Should have a maintenance program

8.  Shall have a regular and efficient cleaning schedule  Surfaces resistant to animals and cleaning  Should not hurt the animals

9.  Separation of non compatible species, in particular for predators and preys.  Physical separation  Visual and olfactive separation  Enough rooms of separated enclosures  Renewal of air without recycling, or with an efficient filter for smells.

10.  The physical plan should include separated areas :  Laboratories for simple diagnostics  Necropsy : Rooms for post-mortem examination  Rooms for procedures, samplings, administration  Rooms for quarantine of newly introduced animals (until the health status is assessed)  Nursery for sick and injured animals

11.  The physical plan should include separated areas : S tore rooms ▪ For cleaning and disinfection products ▪ For carcasses ▪ For food and bedding :  Conservation : temperature and humidity control (in correct range of values)  Protection from pests and insects  Protection against contaminations : should be separated from any chemical storage (cleaning, diagnostic)

14.  The physical plan should include separated areas :.S tore rooms : The Washing Area  Wide enough for the cleaning and disinfection process  Separated flow between dirty and clean equipment  It is necessary to evaluate the global process to understand the need of the facility. It can be very different depending on the species housed or the king of protocols.

15.  The physical plan should include separated areas :.S tore rooms : Surgery  “Suitable equipment” – “aseptic surgery” – “post-operative care”  Washable and easy to disinfection  Rare furniture – leave the soil accessible for cleaning  Cloakroom easy for hand hygiene  Area for preparation : shaving, clipping, disinfection  Dedicated area for recovery

18. Control of Ventilation and Temperature Purpose of the control : biosafety, health and welfare  air circulation : moreover in closes GLP facilities  dust level : - bedding - fur  gas concentration control (ammonia … ) - moreover with increase of animal density

19. Control of Ventilation and Temperature T°C and Humidity shall be adapted to physiological needs of the animals + CONTROLLED and LOGGED daily.  Can be done very simply with a mini/maxi thermometer or a manual system  Can drive to the installation of an automated technical management system :

20. Lighting Lighting is defined by its intensity and its alternation day/light (photoperiod) Natural light provides the ideal conditions. The building has to compensate the default due to the enclosure. The light must be adapted to the requirements of each species and particular specificities.  albinos rodents and rabbits  cats  dogs  monkeys  nocturnal species

21. Lighting AND ADAPTED TO THE NEED OF THE WORKER FOR DAILY PROCEDURES AND EXAMINATIONS  Systems for variation of light intensity  System to monitor day/light alternation  Progressive increase and drop of light for the morning and the evening  Possible to program by computer for each room

22. Alerts - Alarms The system should monitor and regulate temperature and ventilation. Alarms values are useful to maintain temperature and ventilation in adapted ranges. This requirement is compliant with any quality reference.

23. Alerts - Alarms Alarms and alerts are mandatory to guarantee the safety of the animals. Alerts for any vital parameters.  HVAC breakdown : the ventilation stops and animals may quickly miss fresh air in closed systems  Heating breakdown : temperature could dramatically increase or drop to extreme values  Fire

24. Alerts - Alarms These items are more important for the facilities that work on high biosafety levels : 3 and 4 when depression in one the tools used to protect outdoor environment from contamination.

25.  It may be possible to identify clear circulations for :  Staff  Animals  Material  Waste

31.  The equipments that may be found in a facility :  Washing system : automatic washing machine, high pressure cleaner, H2O2 decontamination device  Autoclave sterilizer  Locks  Individual protections : clothes, masks, gloves  Cloakrooms : showers, separation between street clothes and work clothes and shoes

32.  The animal facility is a complex technical tool.  It is an equipment by itself. Its management and maintenance are particularly important and difficult.

34. Thank you for your attention