World Journal of Pharmaceutical Research SJIF Impact Factor 6.805

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1 SJIF Impact Factor Volume 5, Issue 11, Research Article ISSN COMPARATIVE STUDY OF THE AIR HANDLING SYSTEM BY FILTRATION AND HYDRO-PHOTO-IONIZATION IN HOSPITAL STERILIZATION SERVICES I. El Assaad-Idrissi 1, S. Makram 2, Y. Bensouda 3, Y. Cherrah 2, S. Derraji 2* 2 *Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy / Mohammed V University in Rabat. 1 Faculty of Medicine and Pharmacy of Rabat. 3 Laboratory Pharmaceutics, Faculty of Medicine and Pharmacy / Mohammed V University in Rabat. Article Received on 08 Sept. 2016, Revised on 29 Sept. 2016, Accepted on 19 Oct DOI: /wjpr *Corresponding Author S. Derraji Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy / Mohammed V University in Rabat. ABSTRACT Introduction: aerobiocontamination in a hospital sterilization service is a major risk for the sterilization quality of reusable medical devices. The objective of our work is to study two air treatment processes, the first by the particle separation system by filtration, the second by the particle destruction system Photo-Hydro-Ionization (PHI) the Central Sterile Service of HMIMV-Rabat and to review the performance of both systems. Materials and methods: For each area of the Central Sterile Service, samples of air particle counter and aero bio compactor (on Sabouraud culture media and TSA), are made with only the operation of the air handling system by filtration and with the simultaneous operation of the latter with Photo-Hydro-Ionization system thereof, in human absence. Results: The particle count results in the washing area of the CSSD for particles 0,3μm; 0.5 μm; 1,0μm; 5,0μm are respectively: particles; particles; 173, particles; 804particles. For the conditioning zone are : particles; particles; particles; particles. For the sterile area are: particles; particles; particles; particles. For the results of aerobiocontamination are respectively: 4 CFU, 6 CFU, 23UFC. Discussion: Of 49 samples taken with Photo- Hydro-Ionization treatment, the level of particulate contamination and aerobiocontamination improved significantly, the results of the particle decontamination kinetics are inconclusive. Vol 5, Issue 11,

2 Conclusion: In a study of Photo-Hydro-Ionization system alone without the simultaneous use of the system of air filtration treatment would be desirable for an objective evaluation of the added value of this new treatment system. KEYWORDS: Aerobiocontamination; Air treatment; Medical-device; central sterilization. INTRODUCTION In health institutions, contamination control requirements differ depending on the medical procedures practiced in the areas they are dedicated to. To meet these requirements, an analysis of the risk should be performed first, in order to identify an appropriate particle cleanliness class needed for each area. [1] This process then leads to determine the level of performance that needs to be achieved for the installation and make the choice of equipment adapted to prevailing acts. NF S standard specifies safety requirements for design, construction, operation, maintenance and uses the treatment and control of air facilities in health facilities. [2] These concern areas such as interventional sectors, operating ones (including post-interventional), intensive care and resuscitation, protected care, pharmacy, sterilization, laboratories. Those same areas are involved in the global chain of prevention and control of infections related to care in institutions. [3] The operating principle of the conventional installations air treatment in these areas is based on the particle separation; the air cannot be sterilized, but we can only renew the closed circuit or open filtration. [4] In 1985 a new air treatment technology called '' Photo Hydro Ionization (PHI) ''. It then appeared the 2ER technology (for Electromagnetic Energy Reflected) in The great innovation of 2ER system is precisely to tackle the problem of airborne particles by attacking the positive and negative ions whichmeans that the particles finer attract each other, agglomerate and fall to be discharged into the air repeatedly. In parallel, oxidants attack and eliminate microorganisms. [5] This new technology seems interesting to be used in health facilities with no architectural or organizational constraints, to take into account the design of treatment facilities and control of conventional air based on the principle of particle separation by filtration. Hence the relevance of this work is the study of the air-handling performance by PHI in comparison to the conventional device in a sterilization unit of reusable medical devices ISO classe8. [6] Vol 5, Issue 11,

3 MATERIALS AND METHODS This work was conducted in the sterilization services of Military hospital of instruction Mohammed V in Rabat Morocco (MHIMV- Rabat), from 05 April to 28 May It has come to the particulate count and aerobiocontamination part on 0.1μm particle size, 0.3 microns, 0.5 microns, 1.0 microns and 5.0 microns in human absence and local to the resting state. The days Friday Saturday and Sunday were selected best days for this study since the activity is limited to emergency surgery and sterilization team reduced to two employees; 1 - MATERIALS 1-1- Study environment The sterilization services of HMIMV-Rabat is designed on an area of 750 m 2, divided into 4 zones: pre-disinfection area, laundry area, Package area, storage area sterile equipment, ancillary areas - rest, study, cleaning, archives, reserves. Pre-désinfection area Laundry area Vol 5, Issue 11,

4 Package area Storage area stérileéquipement 1-2- Air treatment devices Air Handling Unit(AHU) The air handling system with particulate filter installed in the hospital can be represented by a set of reportable elements characterized by: blowing system Extraction System Filtration air handling units (AHU), heat exchangers, fans, batteries Air treatment device by PHI. Fig.2: PHI cell. Vol 5, Issue 11,

5 It is based on the production of negative ions carrying cold plasma consisting of 5 hyperoxydants friends: hydroperoxidesozonides, superoxide, hydroxides, and ozone called technique due to its presence in small quantities. These oxidants eliminate almost entirely all bio-organisms: bacteria, viruses, microbes, mold, and fungi. [5] However, the first generation of this technology had no effect on flying particles. It returned to traditional filters to separate these particles from the air Particle counter (CLIMET CI-153) Meter portable particle, compact, self-contained with a flow of 28.3 l / min. On an easy and user-friendly programming, it allows editing of complete reports according to ISO and GMP with its integrated printer. [7] 1-4- aerobiocollector (CLIMET CI-95) The CLIMET CI-95 is a germ collector for collecting seeds or viable particles in the air by direct impaction on Petri dish of 90 cm in diameter. The CI-95 is designedto optimize the quality of GMP (Good Manufacturing Practice) samples pharmaceutical industry. [8] 1-5- Culture Media TSA (Tryptic Soy Agar) culture media, adapted to count the total flora, are used for this purpose. Sabouraud medium containing Gentamicin and Chloramphenicol is used for fungal flora. For each storage area, four successive samples at the same point are carried out on three [9; 10] circles TSA (Tryptic Soy Agar) and Sabouraud medium Repositories In interpreting the results the thresholds used are: those recommended by the NF April 6th, 2013 according to AFNOR classification and those recommended by the Good Hospital Pharmacy Practices (BPPH) [1; 2; 3]. 2 - METHODS Due to service operating reasons, the study was complete with the uninterrupted operation of the air handling system by filtration which is the conventional system to HMIM V. The purpose of the study is, in an environment set to generate added value translated by the air handling system PHI which is the system to assess, as a service to patients, nurses, surgeons, the sterilization of staff at the hospital. Vol 5, Issue 11,

6 Sampling plans were developed - Sampling plan particle counting with treatment with AHU - Sampling plan particle counting with treatment with AHU+ PHI - Sampling plan aerobiocontamination with treatment with AHU - To aerobiocontamination sampling plan with treatment with AHU+ PHI - Decontamination kinetic sampling plan in the packaging area with treatment with AHU Decontamination kinetic sampling plan in the packaging area with treatment with AHU+ PHI The number of samples is proportional to the size of the area. + Three sampling points in the wash zone (20%) + Five sampling points in the packaging area (36%) + Four sampling points in the sterile area (24%) Four successive samples in one place will be made the same point, three on a TSA agar and on Sabouraud medium. The achievement of these four successive samples provides a total volume of 1 m 3 (agar Sabouraud included) Figure 3: Model of a sampling plan. Vol 5, Issue 11,

7 3-RESULTS. 3-1-Particle counting results. Figure 4: Particle counting with treatment with AHU Figure 5: Particle counting with treatment with AHU + PHI 3-2-Results aerobiocontamination. Tableau 1: Aerobiocontamination different areas of the sterilization unit. Areaof the sterilization unit washing area (WA) Packagingarea(PA) Sterile area(sa) Grampositive bacilli Gramnegativebacilli Mushroom AHU 11 colonies Absence Absence AHU + PHI 1 colonie Absence Absence AHU 3colonies Absence 1 Absence AHU + PHI 1colonie Absence Absence AHU 5colonies Absence 2 Absence AHU + PHI 6 colonies Absence Absence 3-3-Results of the kinetics of particle decontamination continuously /AHU+PHI /AHU Vol 5, Issue 11,

8 /AHU+PHI /AHU /AHU+PHI /AHU /AHU+PHI /AHU Figure 6: Particles counting continuously. 4- Analysis and discussion of results 4-1-Results analysis Interpretation of particulate and bacteriological results remains difficult. Indeed there is no consensus to pair particulate and bacteriological results. [10] It said it is customary to look bacteriological results when particulate results are suspect. When particulate sampling is ISO 9 and the other ISO 8, bacteriological results are then viewed. If they are correct then the area is classified ISO 8 (cf. interpretation particulate and bacteriological results of air samples). Vol 5, Issue 11,

9 We can therefore note that particulate results are for most rooms, between 8 and ISO 9. As for bacteriological results, they are good enough since they are all worth B100 see B10 corresponding to ISO and ISO 7-8. [6] B100 class comprising 100 CFU / m 3 of air to a maximum which corresponds to 100 CFU for four samples and B10 comprising 10 CFU / m 3 of air Discussion of results Interpretation of particle counting results. The level of particulate contamination for all particle sizes has significantly improved by treatment with additive PHI. For particles 0.3 microns for ZC and ZS the air treatment has improved with PHI device, which excluded the ZL certainly a human presence was a source of contamination making treatment PHI without added value. The PHI has a significant impact on particulate contamination to the size of the particles 1.0 microns and the particle size of 5.0 microns Interpretation of results bacteriological and mycotic. According to NF S results of samples taken were compliant. [2] However there were differences according sterilization areas: In the wash zone (ZL), a lack of BGN and fungi and a significant decrease in BGP UFC after treatment with PHI; which shows an added value of the new system. In the packaging area (ZC), persistence of germs after treatment PHI in certain points or even an increase in other items, and sampling results remain inconclusive. In the sterile area (ZS): total elimination of UFC mushrooms after treatment with PHI; However for BGP conflicting results made of a growing number of UFC even after treatment with PHI. In total the results of our study are not final. Even though, the introduction of this system has enabled a 50% reduction in CFU, a stability was noted in 33% of samples and even an increase in 17 % of samples Interpretation of results of particle decontamination kinetics The overall result of the particle decontamination kinetics conforms with the ISO classification limits 8 of the standard EN [6, 11, 12] However; we noted the following features: Decontamination is done in full activity which may explain the irregularity of graphic curves, the kinetic particle decontamination treatment before PHI edged particles increase followed a decrease from 21h 29mn (5 hours later) and a slight increase which stabilizes at 38,842.5 average particles, particle decontamination kinetics after treatment with Vol 5, Issue 11,

10 PHI showed a slight decrease followed by a significant increase in particles from 19h29mn (3h after) and then stabilizes at particles on the average. 5- CONCLUSIONS The aero bioburden hospital can jeopardize the vital prognosis of patients and that of all stakeholders. Hence the need to establish an efficient air treatment system. [13,14] Thing that prompted us to evaluate the air treatment device PHI sounds simple to install and implement with virtually maintenance virtually absent and an affordable investment cost. The results are not conclusive according to the limitations of our study. The performance of the PHI treatment device could not be identified and documented in an objective way. A study of PHI alone without the simultaneous use of air handling system by filtration (CTA) would be desirable for an objective evaluation of the added value of this new treatment system. However; conclusive observation deserves to be highlighted: PHI enhances the level of particulate contamination of all particle sizes. REFERENCES 1. Good practice of hospital pharmacy - BPPH - June NF April 6, 2013 health- Facilities Zones mastered environment - Requirements for the mastery of airborne contamination, and conditions of use of areas mastered environments. 3. Standard FD S Guide to mastering treatments applied to reusable medical devices - Classification index: S UNICLIMA. Air treatment in hospital.the guides UNICLIMA. SEPAR, Paris, SICAM: The new REME technology (PHI system); CELL REME - Page 1; NF X (NF EN ISO ).Cleanrooms and associated controlled environments - Classification of air cleanliness t detail.html detail.html. 9. N. Lamrani fungal airborne contamination to the hospital. Pharmacy PhD, Faculty of Medicine and Pharmacy flap, 2005; 1: Ahl T, N Dalen, Jorbeck H, Hoborn J. Air contamination During hip and knee., 1995; 66(1): Vol 5, Issue 11,

11 11. ISO / DIS replacements. Horizontal laminar flow randomized versus conventional ventilation. ActaOrthopScand clean and controlled environments rooms. Part 1: General principles. 12. NF S approval procedures and control of operating rooms - Air Quality. 13. J. Charnley, A-sterile operating theater air enclosure. British Journal of Surgery, 1964; 51: PJ. Charnley, Postoperative infection after total hip replacement with reference to air contamination in the operating room.clin. Orthop related Res., 1972; 87: Vol 5, Issue 11,