the sanitization procedure is only verifiable by means of <strong>in</strong>dicators and cannot be captured directly by processparameters like temperature or pressure. The sole process of room gass<strong>in</strong>g will not be discussed <strong>in</strong> this context.4.6.1 Material lockThere are two relevant procedures for heat-sensitive products to cross a barrier via so-called locks: One is bybe<strong>in</strong>g gassed with hydrogen peroxide (H 2O 2), the other is by be<strong>in</strong>g sprayed with peracetic acid (PAA). Specialcases like transferr<strong>in</strong>g items out of S3/S4 areas will not be part of the general discussion here, as these casesalways need to be exam<strong>in</strong>ed <strong>in</strong>dividually. Below you will f<strong>in</strong>d characteristic examples of heat-sensitive productsfor the two presented sanitization procedures:• characteristic heat-sensitive products suited for both procedures: e.g. vacuum-packed, gamma-irradiatedlarge or small feed or bedd<strong>in</strong>g bags,• characteristic heat-sensitive products for H 2O 2use only: e.g. power tools, computers, microscopes, measur<strong>in</strong>gdevices, fan units, cage chang<strong>in</strong>g stations, microbiological safety work benches, ventilated animalhous<strong>in</strong>g cab<strong>in</strong>ets, bedd<strong>in</strong>g disposal stations,• characteristic heat-sensitive products for PAA use only: simple, corrosion-resistant tools, other productswith a solid PAA-resistant surface,• transport conta<strong>in</strong>ers to br<strong>in</strong>g animals <strong>in</strong>to a barrier area.Please note:Due to a material-related heavy absorption, gass<strong>in</strong>g plastic cages with H 2O 2can cause problems with the slowrelease of the gas. The GV-SOLAS thus recommends to refra<strong>in</strong> from gass<strong>in</strong>g plastic cages <strong>in</strong> order to preventanimals from the risk of <strong>in</strong>creased H O exposure.2 24.6.2 Requirements of process<strong>in</strong>g procedures by means of H 2O 2Below you will f<strong>in</strong>d a description of effect and suitability of vaporised H 2O 2for reduc<strong>in</strong>g organisms <strong>in</strong> locks aswell as its limitations of use that need to be exam<strong>in</strong>ed more closely.Sanitization with H 2O 2H 2O 2is a strong oxidant with efficient <strong>in</strong>activat<strong>in</strong>g abilities for microorganisms like spores, bacteria, viruses, andfungi. In liquid and vaporised state, H 2O 2is colourless and odourless. For <strong>in</strong>formation on safe handl<strong>in</strong>g of H 2O 2<strong>in</strong> liquid and vaporised state, please refer to the data sheets on occupational safety (please note the safety datasheets of the manufacturers). Over time H 2O 2<strong>in</strong> liquid state can become <strong>in</strong>creas<strong>in</strong>gly concentrated due to theevaporation of the H 2O. It can therefore easily cause chemical burns (sk<strong>in</strong> contact) and material damage (corrosion).Materials like pulp, textiles, or bedd<strong>in</strong>g (wood) are highly prone to absorb<strong>in</strong>g H 2O 2.Due to chemical reactions,the flashpo<strong>in</strong>t of these materials is lowered. Therefore, these products should not be treated with H 2O 2.Gass<strong>in</strong>g with H 2O 2offers a major advantage to Chlor<strong>in</strong>e Dioxide or Formaldehyde as it produces no visible ortoxic residues. Due to its <strong>in</strong>stability (thermally <strong>in</strong>duced decomposition, light-<strong>in</strong>duced decomposition, catalyticdecomposition), it splits back <strong>in</strong>to H 2O and O 2after the gass<strong>in</strong>g procedure is f<strong>in</strong>ished. Furthermore, a gass<strong>in</strong>gwith H 2O 2can be done at room temperature and atmospheric pressure. Thus, no extra pressure conta<strong>in</strong>er isneeded and the items to be gassed are not exposed to a critical temperature and pressure level.Currently, the common maximum allowable concentration (MAC) is MAC H2O2= 1.0 ppm. Under discussion is avalue of 0.5 ppm. (Please consult the laws and regulations of your respective country/EU standards.)Limitations of use that need to be exam<strong>in</strong>ed closelyBesides the stated lower<strong>in</strong>g of the flash po<strong>in</strong>t, time is always a crucial factor due to the slow release of theH 2O 2from the materials mentioned above. Absorption is not the only pr<strong>in</strong>cipal limitation to be considered here.There are also materials like nylon, rubber, or natural rubber (e.g. floor<strong>in</strong>g) that suffer damages from H 2O 2gass<strong>in</strong>g.It needs to be clarified <strong>in</strong>dividually if a material is resistant to H 2O 2. The surface of the items to be gassedmust be clean, dry, and non porous. Gass<strong>in</strong>g heavily soiled and porous surfaces should be avoided.32Cage Process<strong>in</strong>g <strong>in</strong> <strong>Animal</strong> <strong>Facilities</strong> · 4th issue · 2013
4.6.2.1 Basic lock types for H 2O 2gass<strong>in</strong>gFor gass<strong>in</strong>g items with H 2O 2the follow<strong>in</strong>g basic options are possible:• large, walk-<strong>in</strong> locks (gastight room or sta<strong>in</strong>less steel chamber), common dimension: 2000 mm x 1000 mmx 2000 mm (hxwxd),• small pass-through locks, common dimension: 560 mm x 560 mm x 760 mm (hxwxd),• sterilisers or suitable rack washers that function as locks.When us<strong>in</strong>g sterilisers and rack washers for H 2O 2locks, the additionally required process time needs to beconsidered when calculat<strong>in</strong>g capacity and design of these mach<strong>in</strong>es. For all three options the H 2O 2generatorcan either be <strong>in</strong>stalled permanently or designed as an external, mobile unit that can be docked to the lock.4.6.2.2 Constructional requirementsConstructional requirements <strong>in</strong>clude the mechanical structure, procedural components, and electrical structureof H 2O 2locks.4.6.2.2.1 Mechanical structureThe mechanical structure of an H 2O 2lock must meet the follow<strong>in</strong>g requirements:• Lock chambers must be designed of sta<strong>in</strong>less steel.• With room locks, the material resistance and surface f<strong>in</strong>ish of walls and floors must be verified (H 2O 2-resistantepoxy res<strong>in</strong>).• Gastight doors with a suitable gasket system can be made of safety glass or sta<strong>in</strong>less steel with an <strong>in</strong>spectionw<strong>in</strong>dow.• Airtight connection between lock and build<strong>in</strong>g.• Gauge port or measur<strong>in</strong>g l<strong>in</strong>e for leakage test.• A sampl<strong>in</strong>g port for determ<strong>in</strong><strong>in</strong>g the H 2O 2concentration is to be considered for <strong>in</strong>stallation <strong>in</strong>side the chamberor <strong>in</strong>side the gas return pipe.4.6.2.2.2 Procedural componentsThe follow<strong>in</strong>g procedural components should be considered for H 2O 2locks:• HEPA filter for supply air and exhaust air (either <strong>in</strong>side the lock or on-site).• Air circulation system for gas distribution (<strong>in</strong> small chambers via the generator, <strong>in</strong> big chambers via a rotationsystem or pivot<strong>in</strong>g fans <strong>in</strong>side the lock).• Automatic valves or shut-off dampers with repeater.• Exhaust air conta<strong>in</strong><strong>in</strong>g H 2O 2must only be discharged through the roof via separate exhaust air pipes.• Before be<strong>in</strong>g discharged, the exhaust air conta<strong>in</strong><strong>in</strong>g H 2O 2can be circulated through a catalyser <strong>in</strong> order toreduce the H 2O 2concentration <strong>in</strong>side the discharge air pipe or, where applicable, to avoid the extra pipecompletely.• Gastight shut-off dampers (<strong>in</strong> supply air and discharge air pipe).• The pipe works for the lock (<strong>in</strong>ternally) as well as for the generator connection should be made of sta<strong>in</strong>lesssteel or plastics (e.g. PP, PVC-U). To ensure a universal use, the generator can be equipped with camlockcoupl<strong>in</strong>gs (the dimension<strong>in</strong>g of the connection should be discussed with the manufacturer of the generator).• Galvanised sheet steel and copper pipes (catalytically effective) require special precautions <strong>in</strong> order toprevent material damage and to ensure process effectiveness.4.6.2.2.3 Electrical structureThe electrical structure of H 2O 2locks must meet the follow<strong>in</strong>g requirements:• Control and communication (control via PLC or microprocessor controller, release, signal exchange, start/stop/abort signal, end of gass<strong>in</strong>g, time control via validation) with the H 2O 2generator must be provided.Cage Process<strong>in</strong>g <strong>in</strong> <strong>Animal</strong> <strong>Facilities</strong> · 4th issue · 2013 33