BIBLIOTHèQUE

The Risk analysis procedure for noise and ultrasounds generated by a Multimagic II machine is described in this report. The innovative installation of an Ultrasound generator FISA CM Electronics inside the cap collection crates tank require the evaluation of the noise related risk for the 98/37/EC Machine directive Safety Requirement Number 1.5.8.  The machine once levelled on the floor and positioned far away from any possible external noise source and electromagnetic field was tested for sound pressure levels (machine off and on) and ultrasound emission at the same 8 positions for 30 seconds each.  Results assure that ultrasounds are dampened enough before being reflected outside the vanes of the machine, vibrations are not perceivable on external machine panels and sound level is in compliance with the 98/37/EC Directive.

Kronos is a fully automated system for the complete handling of dirty bottles for watering of laboratory animals. A washing machine, connected to the Kronos, is designed to wash water bottles and their caps in parallel wash chambers that are closed at each end by a guillotine door.   The objective of the study was to assess the washing efficiency of the IWT bottle washing machine operating with the combination of a standard cleaning action due to a detergent/disinfectant agent and the thermal disinfection phase at different temperature and exposure time, in terms of the bacterial load knock down when the water contained in the bottles is preliminary infected with a defined load of 4 different bacterial species in their vegetative form. All cycles were repeated twice each and did show the 100% killing of the infective agents.

An IWT rack washer series 900 was challenged with a load of “eggs holders” artificially contaminated with a complex cocktail of bacteria (106 cfu/ml), mould, yeasts (104 cfu/ml) and the Acholeplasma laidlawii (102 cfu/ml). The rack washer was operated with a solution of NaOH 2% during the washing phase followed by 60 sec thermal disinfection at 82°C.  There was no growth of bacteria, mould, yeast or Acholeplasma from the swabs confirming the efficiency of the cycle and the coverage of the load during the washing action.

The washing machine connected to the Kronos is designed to wash water bottles and their caps in wash chambers that are closed at each end by a guillotine door. Minimal configuration and operating conditions were applied and monitored in this trial. Cycleswith and withoutdetergentsin the washing water were compared. Minimal operating condition due to absence of thermal disinfection was the additional challenging factor.  Bottles and caps were infected with four bacteria singly or mixed together inoculated in sterile water bottles. The interesting results are described in the report.

The efficiency of a tunnel washer to evaluate the degree of cleanliness can be the assessment of the residual bacteriological load on the cages after a cycle when their surface is artificially contaminated with highly concentrated solutions of different micro-organisms. An IWT tunnel washer 10 m long was challenged in its performances by two different type of cages severely infected with four bacteria, one mould, one yeast and their mixture. A complete reduction from two to five log occurred after the cycle which means the achievement of No Growth end point expected vs the positive control.

In vivo tests on washing equipments take to results that are only applicable to the specific working condition of the facility where they are carried out. The report describe the organization and the outcome of a test carried out at an important animal facility where a 9 m IWT tunnel washer working with alkaline detergent only is installed.  The pre-washing microbiological load of Type II Polysulphone cages was ascertained and the following decrease after the cycle was monitored on a number of cages out of 117 washed during standard operations of that unit. The continuous monitoring of temperatures achieved by the different sections of the tunnel washer during the test is also described.

Can a tunnel washer perform as a Washer Disinfector? Is it possible for a tunnel washer to comply with the Health Technical Memorandum 2030 (NHS Estates, Agency of the Department of Health, UK) requirements? In this trial a successful attempt to give a positive answer to these questions was carried out. Modulating the drying temperature, the exposure time and monitoring the surface of a type II polysulphone cage (GM 500, Tecniplast) by means of a Wireless Thermo Recorder RTR-52/53 was possible to define the appropriate parameters of cycles that allow to satisfy the guidelines requirements.

The test was carried out on a standard Tecniplast ISOSLIM unit, connected in loop to a Clarus L H2O2 vapour generator with the target to decontaminate in loop the exhaust portion of Air Handling Unit with vaporized hydrogen peroxide. A suitable cycle was developed and the pertaining SOPs released.

This study was carried out to demonstrate the efficacy of a decontamination cycle within an IWT decontamination lock working in conjunction with a CLORDISYS Chlorine Dioxide gas generator. The characteristics of the decontamination cycles for a standard load were defined monitoring the 100% sporicidal and bactericidal efficacy by means of BIs.  On completion of the cycle, no growth occurred either in TSA, SDA or in spores’ culture media meanwhile the compatibility with the stainless steel did not show any side effect.

Following the first installation of a rack washer XL, a test was put in place to define cycles characteristics in terms of timing and quantity of hydrogen peroxide generated by a Clarus C vapour generator to achieve the 100% sporicidal efficacy assessed by means of BIs. The test was carried out at customer site in cooperation with Bioquell. A suitable decontamination cycle capable to guarantee 100% killing have been developed and validated.

This study was carried out to demonstrate the efficacy of a decontamination cycle within IWT decontamination lock working in conjunction with a Steris VHP1000ED H2O2 vapour generator. The characteristics of the decontamination cycles for a standard load were defined monitoring the 100% sporicidal and bactericidal efficacy by means of BIs and on completion of the cycle, no growth occurred either in TSA, SDA or in spores’ culture media.

A study, requested by a customer, was carried out to validate standard loads to be processed within the decontamination lock recently installed in the facility. Definition of cycles characteristics in terms of phase-time, quantity of hydrogen peroxide and standard loads structure monitoring the 100% sporicidal efficacy by means of BIs demonstrated the efficacy of the cycle and its compatibility with a load composed by electronic equipments such as desk top computer, LCD screen, keyboard and mouse.

Following the first installation of a decontamination lock with the catalyst filter on board, tests were put in place for the definition of cycles characteristics in terms of timing and quantity of hydrogen peroxide generated by a Clarus C vapour generator to achieve the 100% sporicidal efficacy assessed by means of BIs. The test, apart from showing the efficacy of the filtration unit in terms of short cycle time, demonstrated the efficacy of the new design of the decontamination chamber and the 100% killing rate.