Enzyme Indicator Technology and Equipment - Additional Clarification to the Requirements

NHS Wales Shared Services Partnership (NWSSP) is seeking to develop a new approach towards the cleaning of Aseptic Suites and their Clean Rooms. Currently the use of sporicidal wet wipes containing Hydrogen Peroxide is implemented, which presents various Health and Safety risks to our staff, as well as an environmental impact associated with the disposal of many wet wipes per year. NWSSP is now seeking to utilise Ionised Hydrogen Peroxide (iHP) to sterilise the Clean Rooms, as this avoids the Health and Safety risks associated with wet wipes, is a quicker overall process, and enables our staff to work on other activities whilst the gassing cycle occurs. iHP works by damaging organism through the oxidation of cellular proteins, carbohydrates, and lipids.

The current method of validating how clean a Clean Room is uses SDA & TSA Contact and Settle Plates, which is incompatible with using iHP to identify if the room is sufficiently clean – Contact & Settle Plates measure a “Living Rate” on a surface after cleaning, whereas iHP requires a measure of the “Kill Rate” with indicators exposed to the iHP gas during cleaning. To note however, Contact & Settle Plates will still be required as part of environmental monitoring and other Quality Assurance activities).

• The procured solution will be used in Clean Rooms of Grades B, C, and D (as defined within EU GMP Annex 1 – Basic Elements Clean Room Classification)
• The procured solution will be used to verify that a gassing cycle of iHP has been successful in sterilising the exposed rooms

1. The solution Must be compatible with Ionised Hydrogen Peroxide gassing technology
2. The solution Must identify the “Kill Rate” after a room has undergone an Ionised Hydrogen Peroxide gassing cycle
a. “Kill Rate” quantifies the rate at which organisms (including viruses, bacteria, and fungi) within the clean room have been destroyed
3. The solution Must include both the material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material, which arises from the iHP gas – i.e. the results on how successful the iHP gassing cycle has been
4. The solution Must be able to provide results on the Kill Rate within 1 hour of completing the iHP gassing cycle
5. The solution Must indicate whether or not the iHP gassing cycle has been successful – i.e. at minimum, a pass/fail result
6. The solution Should provide results of gassing success in a non-binary manner. I.e. the solution Should indicate how successful the gassing cycle has been in some form of scale, resulting in the ability for the Authority to place Quality Assurance levels to be set for each Clean Room within the Aseptic Suite.
7. All components of the solution (including material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material) Must be operated within the Authority’s premises, and by the Authority’s staff. For the avoidance of doubt, the solution Must not require samples being sent outside of the Authority’s premises for analysis.
8. The solution Must result in the Authority owning equipment. I.e. the core solution (material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material) Must not be provided as a Service, though training and ongoing support is expected to be delivered as a Service.
9. The solution Must have no specialist storage requirements, where refrigeration is deemed to be non-specialist
10. The solution Must require minimal, non-specialist, training to use – i.e. anybody with a basic level of training will be able to use the solution

Enzyme Indicator Technology and Equipment - Additional Clarification to the Requirements

NHS Wales Shared Services Partnership (NWSSP) is seeking to develop a new approach towards the cleaning of Aseptic Suites and their Clean Rooms. Currently the use of sporicidal wet wipes containing Hydrogen Peroxide is implemented, which presents various Health and Safety risks to our staff, as well as an environmental impact associated with the disposal of many wet wipes per year. NWSSP is now seeking to utilise Ionised Hydrogen Peroxide (iHP) to sterilise the Clean Rooms, as this avoids the Health and Safety risks associated with wet wipes, is a quicker overall process, and enables our staff to work on other activities whilst the gassing cycle occurs. iHP works by damaging organism through the oxidation of cellular proteins, carbohydrates, and lipids.

The current method of validating how clean a Clean Room is uses SDA & TSA Contact and Settle Plates, which is incompatible with using iHP to identify if the room is sufficiently clean – Contact & Settle Plates measure a “Living Rate” on a surface after cleaning, whereas iHP requires a measure of the “Kill Rate” with indicators exposed to the iHP gas during cleaning. To note however, Contact & Settle Plates will still be required as part of environmental monitoring and other Quality Assurance activities).

-The procured solution will be used in Clean Rooms of Grades B, C, and D (as defined within EU GMP Annex 1 – Basic Elements Clean Room Classification)
- The procured solution will be used to verify that a gassing cycle of iHP has been successful in sterilising the exposed rooms

The solution Must be compatible with Ionised Hydrogen Peroxide gassing technology
The solution Must identify the “Kill Rate” after a room has undergone an Ionised Hydrogen Peroxide gassing cycle
a. “Kill Rate” quantifies the rate at which organisms (including viruses, bacteria, and fungi) within the clean room have been destroyed
The solution Must include both the material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material, which arises from the iHP gas – i.e., the results on how successful the iHP gassing cycle has been

The solution Must be able to provide results on the Kill Rate within 1 hour of completing the iHP gassing cycle
The solution Must indicate whether or not the iHP gassing cycle has been successful – i.e., at minimum, a pass/fail result
The solution Should provide results of gassing success in a non-binary manner. I.e., the solution Should indicate how successful the gassing cycle has been in some form of scale, resulting in the ability for the Authority to place Quality Assurance levels to be set for each Clean Room within the Aseptic Suite.
All components of the solution (including material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material) Must be operated within the Authority’s premises, and by the Authority’s staff. For the avoidance of doubt, the solution Must not require samples being sent outside of the Authority’s premises for analysis.
The solution Must result in the Authority owning equipment. I.e., the core solution (material that will be exposed to iHP gas, as well as supporting product(s) to measure the Kill Rate of the material) Must not be provided as a Service, though training and ongoing support is expected to be delivered as a Service.
The solution Must have no specialist storage requirements, where refrigeration is deemed to be non-specialist
The solution Must require minimal, non-specialist, training to use – i.e., anybody with a basic level of training will be able to use the solution