Material Transfer Solutions

Scott LodgeTechnical Sales ManagerBiodecon Solutions

Material Decontamination Chamber

Introduction

• Key feature considerations

• Optional high level bio-decontamination integration

• Cycle times and science behind bio-decontamination

• Key advantages of barrier chambers

• Installation and validation

• Summary

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 H2O2

sensors for full environmental monitoring

• Automatic temperature control to prevent over exposure for heat sensitive material

• 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

Key External Chamber Features to Consider

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?

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

• Cycle times are defined as; the time from the start of conditioning to the end of aeration when H2O2 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 H2O2 is between 20 and 50ml per cycle

Conditioning Injection Dwell Aeration

How the Technology Works

The Growth of H2O2

Condensation on Bacteria over Time

Micro-condensation only a fraction of a micron

10 microns

0 to 3 Seconds

35% HPV is injected into the chamber until the air becomes saturated

H2O2 will micro-condensate on all exposed surfaces

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 H2O2 is evaporated from the surfaces

Removal is either by internal catalysts or by discharge to atmosphere, or a combination of both

How The Technology Works….

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

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

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

Examples of PBSC Clients

Questions?