Blue Chip Pharmaceutical Decontamination (North England)

Bio decontamination Ltd was contacted to perform a decontamination of part of a pharmaceutical manufacturing facility in the North of England.

Requirements

A representative of Bio decontamination Ltd paid a visit to the facility and quoted for the decontamination over 3 floors using the G100 HPV systems. A Risk Assessment inspection was undertaken as he toured the facility and any anomalies outside of the normal service delivery parameters were documented. The required service areas included a stairwell and several other areas that would require careful consideration with regard to health & safety.

Solution

After consultation with the service engineers it was proposed that the decontamination process be performed over a weekend when the facility could be clear of personnel, to reduce the risk, although slight, from vapour permeating through the seals necessary to divide the facility into manageable areas. We provided our client with a detailed Risk Assessment and a Method Statement that clearly defined the environmental and safety conditions we expected them to provide, and a step by step procedure for how the decontamination process would proceed. On the agreed weekend, 2 of our engineers arrived at the facility and carried out the set up of equipment to carryout the first procedure using our G100 Series VHP (Dry Vapour Hydrogen Peroxide) system which was to dispense 35% Hydrogen Peroxide. The nozzles were placed in the target area to give maximum coverage with the vapour. Relative Humidity sensors were strategically placed around the room along with the agreed number of bio indicators that would be exposed to the vapour and sealed tubes of Tryptich broth which would be used to transport the bio indicators for processing in the incubator. The area was then sealed and the process begun. The dispersion of the vapour was monitored on the computer that graphs the levels of Relative Humidity encountered by the sensors. (see figures 1 – 6) When the desired rise in RH had been achieved a one hour “kill period” was begun, during which vapour was introduced as required to maintain the RH levels at or above the desired level. After the kill period had elapsed the VHP dispersion was halted and Bio decontamination personnel equipped with the appropriate PPE were able to gain entry and collect the bio indicators, broth and nozzle before the target area was vented through the facility HVAC system. Each of the 6 areas was completed in the same manner over the weekend period and the facility was handed back to the client on Sunday evening and was available for use on Monday morning. The client had the reassurance that the decontamination had been successful through inspection of the Relative Humidity graphs and this was further supported by the negative result for growth on all bio indicators exposed to the vapour. The client was provided with a report of the decontamination process after 7 days, when full results were able to be reported of the bio indicators.

Temperature & Relative Humidity Graphs

Pharma Validation Pharma Validation 2 3 Pharma Validation 4 Pharma Validation 5 Pharma Validation 6 Pharma Validation

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