Material Transfer Solutions. Scott Lodge Technical Sales Manager Biodecon Solutions

Transcription

1 Material Transfer Solutions Scott Lodge Technical Sales Manager Biodecon Solutions

2 Material Decontamination Chamber Introduction Key feature considerations Optional high level biodecontamination integration Cycle times and science behind bio-decontamination Key advantages of barrier chambers Installation and validation Summary

3 Key Internal Chamber Features to Consider Built in fans for moving the gaseous sterilant in and around complex loads The requirement for a relief HEPA filter/catalyst to offset any sudden rise in pressure within the hatch Built in RH, temperature and H 2 O 2 sensors for full environmental monitoring Automatic temperature control to prevent over exposure for heat sensitive material

4 Key External Chamber Features to Consider HMI Control panel screens on each side of hatch for operating and displaying cycle/alarm information Ability to control the decontamination generator from either side of the chamber Emergency over-ride button Automatic door interlocks Inflatable door seals vs mechanical door seals Glass vision panels in each door Easy to access service panel on side of hatch

5 Cart Loading and Unloading Considerations Are the cart sets manufactured in stainless steel? Careful racking design and configuration is has been considered ensuring maximum surface area is exposed to the gaseous sterilant Is the load is transferred from the cart to the main chamber via a sliding rack and rail system? Following decontamination is the load transferred onto a cart inside the clean zone?

6 Cycle Times and 35% Hydrogen Peroxide Vapour (HPV) Gaseous decontamination systems vary in process flow and efficacy. Process flow and science specific to Bioquell 35% HPV Conditioning Injection Dwell Aeration Cycle times are defined as; the time from the start of conditioning to the end of aeration when H 2 O 2 concentration is below 1ppm and it is safe to enter or open the chamber Cycle times will depend upon a number of key factors Under favourable conditions cycles of 35 minutes are achievable Typical usage of H 2 O 2 is between 20 and 50ml per cycle

7 How the Technology Works 35% HPV is injected into the chamber until the air becomes saturated H 2 O 2 will micro-condensate on all exposed surfaces The Growth of H 2 O 2 Condensation on Bacteria over Time 10 microns It is this micro layer of sterilant that deactivates micro-organisms through a process of cellular destruction (through free radicals) Once kill has been achieved, the H 2 O 2 is evaporated from the surfaces Removal is either by internal catalysts or by discharge to atmosphere, or a combination of both 0 to 3 Seconds Micro-condensation only a fraction of a micron

8 How The Technology Works.

9 Key Benefits of Chamber Decontamination Cycle Abilities to integrate modern gaseous decontamination (35% HPV technology to ensure a fast and effective 6-log sporicidal reduction on all exposed surfaces) Utilisation of high level broad spectrum disinfectant (efficacy data available upon request) Ideal for the transfer of heat sensitive material requiring a high level decontamination Leaves no chemical residues on materials Validated cycles for repeatable and safe performance

10 Site Services and Validation Site Acceptance Test (SAT) (Optional) Overall System IQ/OQ on chamber and gaseous generator with integration tests IQ/OQ on gaseous decontamination generator Gas Cycle Development (GCD) based on worst case load scenario or on a number of differing specified loads Onsite Training

11 Summary Safe and rapid method of decontaminating loads for transfer between rooms/ graded zones Fully automated system designed for ease of operation Range of sizes and options to suit different client requirements Many systems / manufactures offer a full range of validation services across their product range

12 Examples of PBSC Clients

13 Questions?