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Pharmaceutical manufacturing

The evaluation of electrolyzed water for endoscopy and acces

Resume

Intention:observe and evaluate the disinfect effect of high concentration pathogenic bacterial pollution for endoscopy and accessories.

Method:measure the bacterial quantity on the endoscopy and accessories with high concentration pathogenic bacterial pollution including:methicillin resistant staphylococcus,klebsiella pneumoniae,pseudomonas aeruginosa,enterococcus,escherichia coli,salmonella,bacillus sp..mycobacterium tuberculosis,helicobacter pylori,candida albicans,coxsackievirus and hepatitis B virus surface antigen.

Result:after 7 minutes’ disinfect,the clamp and lens is no pathogen.after 2 minutes’ washing by running water and minutes’ disinfect ,the accessory is no pathogen.

Conclusion:acidic water is high-effective.safe and facile disinfect method for endoscopy and accessories.

Introduction

Because the endoscopy can be polluted by touching with body liquid and organism in operation course,high-effective and safe disinfect can ensure the operation quality in avoidance with the crossing infection of pathogen diffusion.Here is main way to disinfect in chemical soaking method which is facile but is not enough soaking time and has harm staff body and environment.Here is the research about the research of electrolyzed water for endoscopy and accessories disinfect effect.

1 material and method

1.1 disinfect principle of acidic water

The 0.05% NACL solution by taking 5g NACL into water through the electrolysis cell with cation exchange membrane becomes acidic electrolyzed water in the platinum titanium alloy electrode.The electrolyzed water in positive pole possesses PH value 2.5±0.2 and ORP 1120±70mv to generate antibacterial including CL2,HOCL,HCL and 5±2free residual chlorine and so on.at present,the living value of bacterial and virus is PH value4-9 and ORP -400-900.Except that value,the bacterial is difficult to live and generate.The PH value and ORP in acidic water destroys the pathogen living atmosphere to change the potential difference inside cell leading to die because of adding permeability to destroy metabolism enzyme.Free potential chlorine and HCLO enhance the disinfect of acidic water.

1.2 the choice of testing bacterial species

The potential polluted bacterial group including methicillin resistant staphylococcus,klebsiella pneumoniae,pseudomonas aeruginosa,enterococcus,escherichia coli,salmonella,bacillus sp..mycobacterium tuberculosis,helicobacter pylori,candida albicans,coxsackievirus and hepatitis B virus surface antigen.

1.3 the generation of bacterial solution

Select the bacterial group from ATB semi-automatic bacterial detector.After blood agar plate culture,the concentration of bacterial is adjusted to 107-108CFU/ml in proportion with turbidity tube.Mycobacterium tuberculosis including wax composition in LUO culture tube is cleaned into 10.0 sterile salt water.reserve viral titer 107-TCID50that inoculate the coxsackievirus solution diluted by 1:100 to cell pathological change8%the mixed positive serum(10ml) is the hepatitis B surface antigen in clinic testing.

1.4 polluted treatment of endoscopy and accessory

The lens of pliers which is produced by Japan is the section of observation.The pollution manipulation:the 15cm front part is soaked in all kind of bacterial solution about 30 seconds,and is soaked in 20ml salt water about 30 minutes,as is the basic pollution value.The lens cleaned by sterile gauze is soaked in bacterial solution in 30 seconds to be disinfected in automatic disinfect machine.After that,soak into the 20ml salt water as effect testing solution after disinfect.

The pollution treatment of pliers is that the bacterial solution inject into the hole and cleanit by 10 ml salt water.the cleaning solution is as the basic pollution value and disinfect after second pollution.After disinfect,the cleaning solution is also as effect observing liquid.The species of accessories are included common biopsy forceps,polyp snare,pancreatic duct and papillary muscle knife.

1.5 the treatment of testing sample

After receiving all testing samples,the broth nutrient solution is diluted 10 times(10-1-10-7).Each culture plate is treated by 100ml nutrient agar and 3 plates each diluted solution.Observe the concentration of microbe in 37 degree after 48 hours.Hepatitis B virus surface antigen is tested hepatitis B virus surface antigen reagent in shanghai huangke company.Coxsackievirus B is tested by HELA cell in concentration of 50% TCID50to evaluate antiviral effect.The disinfect effect evaluation of helicobacter pylori is inoculation culture and its growth.

2. Result

2.1 the observation of the disinfect effect for automatic sterilizing instrument
 

Bacterial name Culture medium Before disinfect After disinfect
lens Tong road accessories lens Tong road accessories
methicillin resistant staphylococcus Nutrient agar 2.5*105 2.0*106 4.5*106 0 0 0
klebsiella pneumoniae Nutrient agar 3.0*105 1.0*107 3.2*106 0 0 0
pseudomonas aeruginosa Nutrient agar 1.5*105 1.2*107 5.1*106 0 0 0
enterococcus Nutrient agar 4.0*105 1.5*107 2.8*106 0 0 0
escherichia coli Nutrient agar 2.0*105 1.4*107 6.7*106 0 0 0
salmonella Nutrient agar 2.0*105 1.0*107 5.5*106 0 0 0
bacillus sp. Nutrient agar 4.0*105 7.7*107 3.4*106 0 0 0
mycobacterium tuberculosis luoqinguan grow grow grow Non-grow Non-grow Non-grow
helicobacter pylori   3.75*106 3.0*107 5.5*106 0 0 0
candida albicans Sand agar 4.6*105 6.0*105 1.7*105 0 0 0
 

A.Adding 2%yeast extract

B.After inoculation,it is advisible under 5d magnifier

C.Insistantly culture 4wk and 8wk without growth.

2.2 The evaluation of electrolyzed water for endoscopy and accessories disinfect effect

Table 2 acidic water for disinfect effect of coxsackievirus and hepatitis B virus surface antigen.

Bacterial name Testing method Before disinfect After disinfect
    lens Tong road accessories lens Tong road accessories
HBsAg Mixed serum 0.628 0.701 0.657 0.024 0.020 0.018
hepatitis B virus 10 -6 TCID 50/ml b 10-5 10-5 10-5 undetectable undetectable undetectable
 

The absorbance and control of quality is 0.105 as posive in 450nm wavelength.b TCID50Is tissue cell lesion measurement unit.

3. Discussion

The manipulate procession and property of endoscopy has high pollution and potential crossing infection.It is high attention for its not strict disinfect leading to microbe diffusion and impact the quality and effect.In domestic,the chemical soaking disinfect has theoretically good effect.but in practice,the quality and effect is not well because the operation time is more and the disinfect procession is not strict.the work power is big and the chemical reagent is harmful for staff,as is the inevitable problem.It is the good step for introducing the acidic water disinfect method,which has many advantages alike little time,broad disinfect without chemical detergent and non-pollution.Japan has the animal experiment for electrolyzed water,which can release electron in touch with skin to become neutral without any irritation for skin,eyes and membrane.The endoscopy soaked in 1000 times has no change alike deformation and aging and abnormal technological index.It is safe for endoscopy and human body.

Here are many disinfect effect for electrolyzed water in whichthe disinfect time of( 10 3 -10 4CFU/ml)is 25-30 seconds including methicillin resistant staphylococcus,klebsiella pneumoniae,pseudomonas aeruginosa.In this study,we have selected the overdose pathogen(10 6 -10 8 CFU/ml )to disinfect in electrolyzed water under no running water cleaning.The result shows that,in the disinfect time 7 minutes,the electrolyzed water can effectively kill normal pathogens,coxsackievirus and hepatitis B virus. The disinfect ability is over the practical application.

The running water cleaning is overwhelming,enough timing and utter step before disinfect.The research shows that the running water cleaning 2 minute before disinfect can kill 70-80%pathogen on the surface to enhance the disinfect effect.the pre-testing in accessories shows that,if the accessories is not cleaned by water before disinfect.the pathogen is still growing after 7 minutes.But after cleaning and disinfect,here is no growth.So The running water cleaning is overwhelming,enough timing and utter step which is the critical in the disinfect course.

Moreover,the acidic water is different from other disinfect method due to the facile manipulation,broad disinfect scope and non pollution and once-time disinfect for all accessories.Although the machine is high price,the using time is not.It can’t harm human body no need of chemical detergent.Here are some more rectified steps including the more time for electrolyzed water about 45 minutes.Handle and knob can’t be disinfected and some parts be dispatched from main machine.From the effect of documentary and clinic,the acidic water is the high-effective,rapid,safe and convenient disinfect way.But it needs long term to observe and research.


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