Quality of pharmaceutical production is put by technology and the manufacture organization, including the cleanliness of technological mediums. Since 2000 Miass Factory of Medical Equipment has carried out designing and construction of cleanrooms for different fields of industries. As the base for this direction of activity 10-years-old experience of our factory in creation of cleanrooms for medical units serves...
CLEANROOM
Air treatment, decontamination and distribution system;
Climate control system;
Cleanroom structure (structural elements providing leakproofness);
medical, technological and engineering equipment integrated with the cleanroom structure.
The long finding of patients in hospitals becomes dangerous for them because already after short time all of them become bacilli carriers so-called hospital stocks and carriers of a various infection. Itconcernsaswellthepersonnelofmedicalinstitutions.
The wide circulation of an hospital infection is connected with decrease in activity of an patient organism, change of structure and biological properties of microorganisms against decrease in efficiency of widely applied antibiotics and antiseptic preparations, occurrence steady against them various stocks microbial associations.
In comparison with traditional methods of preventive maintenance and the infection treatment, directed on struggle and destruction already available in microorganisms, basic difference of cleanrooms consists in constant removal by an air stream appearing in microorganisms and creation of reliable barrier to microflora available out of cleanroom.
Complexes of cleanrooms are carried out with observance of requirements of operating standard documents that consist in the following:
Architecturally-building decisions and internal furnishing of premises:
an exception of mutual crossing of transits of "sterile", "pure" and "dirty" technological streams that is provided with a lay-out of cleanrooms;
zoning of premises with identical degree of cleanliness;
application of a special design tight hygienic walling and ceiling protections, which:
have the smooth internal surfaces easily accessible to washing and processing by disinfectants;
have hermetically sealed and issued by a profile of the rounded off form joints between walls, floor and ceiling;
are made of the fire-resistant and nontoxic materials steady against influence of disinfectants and an ultra-violet irradiation;
application for a covering of a floor by antistatic linoleum.
On heating, ventilation, microclimate and the air environment of premises:
definition of productivity of ventilation systems according to categories of premises on cleanliness;
highly effective clearing, as a rule, three-stage (terminal filters of class Н11-Н14) and a bactericidal irradiation of incoming air;
clearing (terminal filters of class Н11-Н14) and bactericidal irradiation of internal air of premises of a category "especially pure";
air-conditioning and humidifying of submitted air;
giving of air with the organization the set direction of the movement considering features of a premise;
rational organization of airflow, that guarantee avoiding overflows of air from less pure zones in purer.
On illumination:
application of enclosed illuminators, capable to maintain sanitary processing by disinfectants;
application of ultra-violet irradiators for air disinfecting. Performance of the specified requirements at creation of complexes of cleanrooms comfortable working conditions of the personnel and treatment of patients provide air environment with low level of bacterization.
More than 30 % patients among all hospitalized are surgical, thus about half operated – patients are more senior 45 years (the group of the raised riskdevelopment of an infection in the postoperative period).
In modern conditions surgical in-patient hospitals – in fact are infection sections, in which however the mode of infectious hospital is not organized. It can lead to preservation and accumulation in departments of hospital activators.
The possibility of infection operated people considerably above in comparison with other hospitalized. It’s caused by that patients are in hospital longer, have extensive entrance gate for the infection activator, are exposed to influence of the numerous factors raising risk of development disease at various mechanisms of infection.To such factors belong: age of patients, operations lasting more than 4 hours, plural traumas, extensive thermal defeats, earlier transferred infections, repeated operations, long terms of stay in hospital, long application of antibacterial preparations and so on.
Successful struggle against hospital infections in premises of operating theatre is impossible without creation of obstacles in a way of distribution of infection activators.
The complex of equipment cleanrooms of operating theatre in general includes following modules:
the module of an operating theatre;
the module of preoperating;
the premise module of patient preparation (narcotic);
the module of sterilizing;
the module of postoperative (postoperative room).
Designing of these modules is carried out with meeting requirements of standard documents with following features:
in operating theatre , a premise of patient preparation (narcotic) and postoperative room internal clearing of air by means of what frequency rate of air exchange more than 20 is reached is carry out
air delivery in zone of an operation table in an operating theatre is carried out by a falling laminar stream that creates an air passage with the raised frequency rate of air exchange and allows to reach the highest lever of cleanliness;
air delivery in the preoperative and sterilizing is carried by a turbulent stream;
in maintenance of connection of electroequipment and supply of medical gases in, an operating theatre installation of the ceiling console of the surgeon and in preparation of patient (narcotic) and postoperative chamber – the wall medical supply console is provided;
local illuminating in operating theatres is provided with installation of the operational fixture;
for transfer of materials and tools between sterilizing and an operating theatre performance of pass-through windows is provided.
The contingent of the patient who is in branches of resuscitation, is characterized by considerable infringements of the immune status as a result of the basic disease and operative intervention.These patients are most subject to colonization hospital stocks is conditional-pathogenic microflora.
The risk of development of hospital disease in resuscitation units is highest and reaches 20-25 % and at separate kinds of pathology – to 70 %.
Increasing value of branches of resuscitation and intensive care units in occurrence of hospital infections causes a presentation of increased requirements to planning decisions of these branches, observance of sanitary-and-hygienic and antiepidemic regimes
In general the complex of cleanrooms for operating theatres and intensive care units includes the following modules:
the module of resuscitation unit;
the module of preoperational;
the module of the intensive care unit.
Designing of the specified modules is carried out with meeting all requirements standard documents with following features:
in resuscitation and intensive care units internal clearing of air by means of what frequency rate of air exchange more than 20 is reached is carry out;
air delivery in zone of an operation table in a resuscitation unit is carried out by a falling laminar stream that creates an air passage with the raised frequency rate of air exchange and allows to reach the highest lever of cleanliness;
air delivery in the preresuscitation and intensive care unit is carried by a turbulent stream;
in maintenance of connection of electroequipment and supply of medical gases in, a resuscitation unit installation of the ceiling console of the anasthesiologist and in intensive care unit – the wall medical supply console is provided;
The variety of clinical forms of hospital infections of newborns and women in childbirth is caused by presence of plural gate of an infection (skin, mucous membranes of the top respiratory ways and eyes, intestines, umbilical injury), also is conditional-pathogenic character of activator causing these diseases.
On a share of purulent-septic diseases in the pathology structure there are 4-5 % of newborns. During flashes of these disease depth can be reach 18 %.
One of the basic ways of distribution of hospital infection in maieutologist in-patient clinic is hospital air, where there are aerogene activators of illnesses even when you observe all the rules of current and final disinfection.
The complex of cleanrooms removes the problem of staphylococcal infection in maternity hospitals.
The complex of cleanrooms in maternity hospitals includes following modules:
the module of patrimonial room;
the module of prepartimonial room;
the module of preparation premise for personnel;
the module of resuscitation for newborns;
the module of small operating with a sluice;
the module of the sterilizing room;
the module of the postoperative chamber;
the module of the intensive care unit.
Designing of these modules is carried out with meeting requirements of standard documents with following features:
in patrimonial room, postoperative, resuscitation room for newborns, intensive care unit internal clearing of air by means of what frequency rate of air exchange more than 20 is reached is carry out;
air delivery in zone of an operation table in an small operating and to the zone of maientologist bed is carried out by a falling laminar stream that creates an air passage with the raised frequency rate of air exchange and allows to reach the highest lever of cleanliness;
air delivery in the other premises is carried by a turbulent stream;
in maintenance of connection of electroequipment and supply of medical gases in, an small operating installation of the ceiling console of the surgeon and in intensive care unit – the wall medical supply console is provided;
local illuminating in small operating and patrimonial room is provided with installation of the operational fixture.
Aseptic boxes for patients with immunodeficient disease
World and domestic experience shows that the treatment of patients with immunodeficient disease should be made in special aseptic chambers, provided antimicrobic mode with requirement parameters of air environment and microclimate.
Typical aseptic laminar chamber represents the complex of equipment, placed by a principle “premise in premise”. Isolation of patient from aerogene infection activators is reached without loss of possibility of contact to personnel and relatives.
The structure of the equipment and its placing are individual for every concrete case and are defined during the projecting process taking into accountinitial parameters and premise lay-on, and also Customer’s wishes.
In the result of cleanrooms placing the initial premise is divided into zones:
zone for treatment (further – box);
zone for supervision (preboxing);
technological zone.
The box is calculated on 1-2 cots.
The creation of horizontal and vertical laminar air flow with automatically supported standard characteristics of microclimate is provided. Highly effective cleaning (2-3 steps, the terminal filter of class no less than H13), disinfecting of air arriving in boxing by an ultraviolet irradiation at frequency rate of air exchange not less than 50 allow to provide a cleanless class not more low P7 (10000) 0,5 MK (100) (see GOST R 50766-95).
Presence in clinic hospital stocks and various infection activators makes even short finding of patients in in-patient clinics dangerous for them. The same concerns to the medical staff.
By this time the technology of cleanliness in hospitals became an integral part of civilized health care.
Module designing of hemodialysis room of cleanrooms is carried out with all requirements to the operating standards documents. The structure of protecting designs and ventilation and air conditioning system is defined during the designing take into account initial parameters , premise lay-on and Customer’s wishes.
Reliable protection of the pathologist against streams of formalin and gassing from the object of work.
Scopes:
autopsy pathologist rooms;
branches of medicolegal investigation;
thanatological units.
For maintenance of comfortable working conditions of pathologist, his reliable protection against stream of formalin and gassing from the working object, the workplace of pathologist is created. It’s the independent module, that carry out direct incoming air flow through linear air terminal device to the table zone, air intake through ventilation hole on perimeter of the table and removal of the air to building limits. Such organization of positive-pressure system at enough high speed of an air stream creates a stable air veil on perimeter of the table with formation of an original air capsule in which there is a table-top of a section table with tools and anatomized object and at opening or fence realization of biopsing and operating material only hands of the anatomist. The quantity of the deleted air prevails over incoming, that provides false air in a capsule from the autopsy premises and the absence of air overflows from this capsule with polluted air in the section is guaranteed.
Heating and temperature regulation of in-coming air in a cold season is carried out by the built in electric heater. For illumination of a work area to the in-coming block, the luminescent fixtures are built in.
At necessity (depending on profile of autopsy room) deleted air can pass clearing on filters and be made its bacterial processing by Uv-irradiation lamps.