CAGE PROCESSING in Animal Facilities - GV-SOLAS

PermissionsWith frequent changes in operating staff, it is recommended to protect the program start with passwords (staffpassword). In order to make adjustments at the machine or to run special programs (e.g. removal of a barrier)it is recommended to allocate further passwords or key switches to selected personnel only.Vacuum pumpOperating vacuum pumps produce relatively high noise levels, that can reach even the animal rooms. Asmany animals are very sensitive towards noise, it is recommended to set up the vacuum pumps in engineeringrooms further away. If there is not enough space available for an external installation of vacuum pumps,sound-damping measures inside the steriliser should be taken without fail.Central recording of malfunction noticesThe steriliser should be able to automatically forward process-relevant notices of malfunction to a central controlroom.Remote diagnosisFor a fast and effective removal of malfunctions, the steriliser should be equipped with an interface for remotediagnosis.Feeding steam into the chamberSterilising cages with bedding inside puts high demands on the steam supply. When feeding steam into achamber, the steam must not be directed at the cages to avoid the bedding been blown around. For a gentledispersion of steam, special attachments on the chamber wall are necessary. An accumulation of bedding onthe chamber floor, however, cannot be fully avoided. Therefore, the floor should be easy to clean (sweep),which means it should also be free from attachments. Existing dirt traps and filters should be convenientlyaccessible and easy to clean. Also, evacuation openings must be equipped with a filter to prevent beddingmaterial from being sucked in.Steam sterilisation chamber with floor level accessThe chamber floor should allow for a flexible use of loading trolleys with different track widths (no protrudingattachments in the floor area).Flexible reference probe for sterilising filled water bottlesA temperature probe should be well accessible from both sides. When running programs without using thereference probe, the probe and its cable should be mechanically attached to the chamber wall and thus beshielded. In some cases it can be necessary to protect the cable with an additional metal hose.Interlocking door mechanismIn machines installed within an airtight barrier, it is necessary to define a specific direction in which items mustalways be sterilised. In the opposite direction, however, it is usually possible to transfer items through the steriliserwithout actually sterilising them. It is important to determine exactly in which direction the steam sterilisationis done (SPF area, quarantine area). Special cases might occur where it is necessary to sterilise items inboth directions. The exact program or possible changes between these options must be specified in advance.Cycle documentationIn order to document the steam sterilisation process, a continual record of the temperature and pressure profileis important. According to GLP, documentation is necessary for assigning a given item to a recorded cycle.A cycle document should always contain information on temperature and pressure, as well as on the date andtime, the type of steam sterilisation program, cycle number, and release.4.5.2 Special requirements on process validationExplanations on above subject will be included in the 5 th edition.4.6 Reduction of microorganisms on heat-sensitive products by means ofhydrogen peroxide (H 2O 2) / peracetic acid (PAA)In cage processing transferring non-steam-sterilisable, heat-sensitive products in and out of a barrier area is ofcrucial interest. This procedure is usually done by means of H 2O 2/ PAA is generally known as sanitization andaims at inactivating pathogenic micro-organisms. Other than with thermal steam sterilisation the local effect ofCage Processing in Animal Facilities · 4th issue · 2013 31