The Chapter 22 Aseptiki and sterility.
Asepiic conditions. Sources of pollution inektsionnyh
Solutions. Àñåïòèêè and sterility.
Asepticheskie conditions of manufacture of medical products is
A complex of technological and hygienic actions
Providing protection of a product against hit in him
Microorganisms at all stages of technological process.
Asepticheskie conditions are necessary at manufacturing termolabilnyh
Preparations, and also unstable systems - emulsy, suspensions,
kolloidnyh solutions, i.e. the preparations which are not subjected
Sterilizations.
However not a smaller role play observance of rules aseptiki at
Preparation of medical products maintaining thermal
Sterilization since this method of sterilization does not release
A product from the lost microorganisms and their toxins that can
To lead to pirogennoj to reaction at an injection of such preparation.
Pollution parenteralnyh preparations divide into three types:
Chemical, microbic and mechanical. Last two types
Pollution are closely connected among themselves: often are identical them
Sources, are similar also methods of struggle against these pollution.
For example, taking place in air of industrial premises
Microorganisms are always adsorbed on firm particles or
Are switched on in drops of liquids. Therefore kill of all weighed in
Air of particles relieves it and of microorganisms.
Sources of pollution inektsionnyh solutions.
Sources of chemical pollution serve raw material, auxiliary
Materials. In synthetic preparations probably presence
Reagents or intermediate preparations, from membrannyh filters
Can be poured out PEAHENS. Chemical pollution are most dangerous,
Possessing biological activity or toxicity.
Sources of microbic and mechanical pollution same:
Poor-quality kill;
The process equipment, is especial his rubed details;
Air;
The personnel;
Poor prepared ampoules.
From these sources in a product microorganisms can get,
chastichki metal, a rust, a glass, wood rubbers, p/m, coal,
Ashes, starch, talc, a fibre, asbestos.
On all firm particles can be adsorbed
Microorganisms. All entered into the closed system
Blood circulations of a particle in her remain. Mechanical inclusions
Can lead to to education of blood clots, granulem, allergic
Reactions and other pathological phenomena. Asbestos is especially dangerous,
Since contained in him hrizotil can cause
Malignant novoobrazovany. It has formed the basis for
An interdiction on use of asbestos in manufacture inektsionnyh
Preparations. Fibres of cellulose and chastichek p/m, entered
Intravenously, being the reason granulem and microblood clots in
Easy patients (it is revealed at pathoanatomical
Researches of patients, a plenty intravenous is received
Injections.).
The requirements showed to inektsionnym to solutions.
The basic requirements showed to inektsionnym to preparations,
Are sterility, apirogennost and absence mechanical
Inclusions. Under requirements GF XI - « should be absent
Mechanical impurity ». Requirements of other countries limited
Quantity of particles invisible to the naked eye, as in
These countries there are the devices, allowing to supervise
Such particles.
Sterility - full absence of alive microorganisms and them
Dispute.
Pirogenny - products of ability to live and disintegration
The microorganisms, the lost microbic cells. On chemical
To structure it is Naval Forces lipopolisaharidnoj the nature with M.m. Up to 8·106. At
Introduction of the solution containing pirogenny differs raised
A body temperature, and sometimes and falling of arterial pressure,
A fever, vomitting, a diarrhea. It termolabilnost substances, which
Collapses at temperature 250? With within 30 minutes. In
Manufacture inektsionnyh preparations from pirogennov are released
Various physical and chemical methods - way propuskanija
A solution through columns with the activated coal, cellulose,
membrannye ultrafilters.
Maintenance asepticheskih conditions of manufacture inektsionnyh
Preparations.
Here it is necessary to allocate some the key moments:
A premise, the personnel, raw material, the equipment and cleanliness of container.
An industrial premise - inektsionnye preparations
Are going in special, only for these purposes
The intended premise. The device of these premises should be
Is subordinated an overall objective - to data to the minimal opportunity
Pollution of a product, i.e. a minimum of places of a congestion of a dust, submission
Air, controllable cleanliness, podderzhivanie raised
Pressure. If necessary in a premise support
The certain temperature and humidity. Such premises name
"Pure". Under domestic standards in « pure premises »
podpor air there should be 4 mm rt. An item t = 23 yo 2? With,
Relative W = 30 - 40 %. At W > 50 % begin corrosion
Metal details, since hygroscopic particles on
Surfaces absorb from air so much a moisture that become
Initiators of corrosion. At low relative W on
Dielectric metals can collect static
An electricity and consequently, keep particles of a dust.
A recommended arrangement of " a pure premise » in the middle
Buildings, without contact to external walls. An input in premises
It is expedient to equip with an air gateway in which it is blown off
A dust from clothes and footwear of the personnel.
Walls, the floor, a ceiling should be smooth, l/ochishch., and interface
Walls among themselves and walls with a floor executed with zakrugleniem R 300
Mm. Such outline of the arch will reduce dead space and
Will exclude an opportunity of accumulation of a dust, and also stagnation of air.
It is necessary to avoid ledges and niches. Walls of " pure premises »
Are covered polished metals (Àl, stainless steel), p/m or
epoksidnymi enamels. Have well recommended itself partitions
Firms " Glatt " from polistirolnoj foams with reveted apodirov. Àl.
Firm " Sterile " with success partitions from usual are applied
A laying with pasted to walls and a floor a polyvinyl covering,
Which weld, hot way. As a covering for
A floor - polivinilhlorod, epoksidnye and poliuretanovye pitches.
However they possess low stability to tsarapanju. The best on
Today - a covering of a floor a ceramic bar. For
A boundary - a vinylic sheet material with switched on in him
Ceramic bars 25 * 25 mm. At stacking a covering
Heat up, p/m fills in seams between bars and form
Monolithic coverings. Such floors possess high stability.
Chairs, tables in « a pure premise » - from p/m and metal
Legs of round section.
Cleaning a premise - one of the important actions, on maintenance
Cleanliness. The purpose of cleaning - data to minimal mechanical and
Microbic impurity. Completely to destroy all
Microorganisms it is impossible. However at careful and regular
To cleaning achievement 2 classes of cleanliness, the maintenance is real
Microorganisms it is reduced on 40 - 60 %. Remain usually
Not pathogenic microorganisms, however and them it is necessary to destroy,
As they inaktivirujut medicinal substance.
At a choice of disinfectant substance it is necessary to take into account not
Only his bactericidal properties, but also possible toxicity
For the person. I use the diversified disinfectant
Means: 2 - 6 % peroxide of hydrogen, with washing-up liquids
sulfanol or "Progress", pairs formaldehyde, jodoform.
However long use to - l disinfectant
Means results in education of stability shtammov. Therefore
It is recommended to change a disinfectant each 14 days.
Air of industrial premises - the most significant
A potential source of pollution of medicines, therefore his clearing
Is one of key questions of technological hygiene.
The level of cleanliness of air, is in the premises, certain
A class of cleanliness (see 1 and 2 lectures). Air subject to the control on
A site of pouring, a site of cooling in the tunnel, on memory
To pitch, near to the operator. 1 time a quarter carry out
Microbiological inspection asepticheskoj installation for
Pouring: in 10000 ampoules package a nutrient medium and through
14 days check the maintenance of ampoules.
Maintenance of an industrial premise with pure air. This
The problem is solved at the expense of use of systems of ventilation with
A laminar stream on all area of a premise. In premises
Force through separately located in a ceiling diffuzory
Carefully filtered and conditioned air, deleting
It through the return air lines located at a floor on
To perimeter of a room. Premises with laminar streams are such
Premises in which air moves in the direction of the worker
To a zone through the filters borrowing all wall or a ceiling, and
Leaves through a surface opposite to an input of air.
Laminar air stream (LVP) is defined a stream, in which
All weight of air in the limited volume goes with identical
In volume lengthways in parallel lines of a stream.
Average speed LVP of 27,5 m / mines (0,45 m/sek). Distinguish
Vertical and horizontal LVP. The laminar stream carries away from
Rooms all particles weighed in air acting from any
Sources (the personnel, the equipment, etc.). For maintenance
Required cleanliness of air in systems VLP and GLP are applied
Highly effective filters such as NERA (Íigh efficiency particulate),
As a filtering material - fiber glass. Firm " ÍÅÐÀ "
Detains mechanical and biological particles in the size 0,3
A micron with efficiency 95 - 99 %, and absolute - particles from 0,1 microns
With efficiency of 99,999 %. In the domestic industry for
Final clearing are applied f. "LAIK".
The personnel. Equipment of manufacture by laminar streams and submission
In a premise of pure and sterile air yet the decision
Problems of " a pure premise », since working in a premise the personnel
Also is an active source of pollution. Therefore
It is desirable, that in « a pure premise » in an operating time
There was a minimum quantity of people.
Within 1 minute the person, not moving, allocates 100 thousand
Particles. This figure grows up to 10 million during intensive
Jobs. Average quantity of the microorganisms, selected with the person
For 1 minute reaches 1500 - 3000.
Therefore protection of medical products from polluted
Sources which the person one of the basic problems is
Technological hygiene.
She is solved due to personal hygiene of employees and application
Technological clothes. The personnel before job in asepticheskih
Conditions has training special preparation and training - lectures,
Show of slides, practical employment.
Preparation for job begins with washing hands. Usually, hands wash
Soap and a brush with consecutive opolaskivaniem water. Then
Hands disinfect (spirit or spirtovye solutions disinfectant
Means). People with diseases of a leather or respiratory ways, and
Also with raised potlivostju and dryness of a leather to job in
asepticheskih conditions are not supposed. Hands of the personnel after
Disinfection should be sterile. Drying of hands - not warm
Air, and in the way vytiranija paper napkins.
The important question is the arrangement of a premise for preparation
The personnel.
The circuit of movement of the personnel to « a pure premise ».
In garderobnoj And the overalls, in umyvalnoj And carefully is put on
Wash hands, in garderobnoj the sterile clothes Would be put on, in
umyvalne I Would shall disinfect hands.
Technological clothes - as much as possible protected product from
The particles selected with the person. The complete set of technological clothes-
An overalls of an adjoining silhouette without pockets and belts, head
ubor, bahily and rubber gloves. In clothes a minimum of seams, edges
Are filled inside. A fabric - a minimum vorsootdelenie,
Air-penetrable, dustproof, does not accumulate
A statistical electricity. From polyester, polipropilenovyh and
polialkidnyh fibres. Domestic - a mix of lavsan with a clap.
Gloves - surgical, preliminary processed by soap,
Then a solution silikonovoj emulsii (instead of talc) and
Sterilizations in an autoclave. Clothes change at each input,
A protective mask each 2 hours.
Raw material. A source of microbic impurity can be and raw material.
The sterilized filtering releases a solution from
Microorganisms, however, efficiency of filtering depends from
Cleanliness of an initial solution. The temperature has more value
Storages of raw material. So, at fluctuations of temperature of dry raw material with
sod. vl > 5 % on tightness of packing forming a condensate,
Which is capable to make multiple copies microorganisms quickly.
The most important raw material - water (in the following lecture).
The equipment (it will be considered in the following lecture)
Sterilization - is of great importance at creation of conditions
aseptiki. GF XI: Sterilization - process of killing in object
Or removal from him microorganisms of all kinds which are taking place on
All stages of development.
The following methods of sterilization:
Thermal - steam and air;
Chemical - gas and various solutions;
Filtering;
Radiating.
1.1. Steam - sated water the ferry at temperature 120? With (Rizb
= 0,2 MPa) are recommended for solutions of medicinal substances.
Time of sterilization - from fiziko - chemical properties of a preparation,
Volume of a solution (water solutions).
Volume, ml Time, mines
Up to 1008
From 100 up to 50012 t = 120? With
From 500 up to 100015
Fats and oils - 2 hours at t = 120? With
Utensils glass and porcelain. The filter a material, overalls - 120?-
45 '; 132? - 20 '
The equipment - ÃÏ-400, ÃÏ-280, ÃÏÄ-280 (pass) - rectangular,
ÃÊ-100 (round), VK-vertikaln. A circle., ÃÏ-1000, ÃÏ-1700.
1.2. Air - dry hot air at 180? Or 200? With.
It is recommended for sterilization of powder substances (NàÑl, oksid
Zn, talc, white clay).
Weight, g temperature? About time, mines
Up to 2518030
10
From 25 up to 10018040
20
From 100 up to 20018060
30
Glass metal, silicone. rez. Porcelain. - at 180? - 60 ' and t =
160? With - 2,5÷àñà. Solutions - it is impossible.
The equipment - ØÑÑ-250, ØÑÑ-500 and ØÑÑ-500Ï, ØÑÑ-100Ï, ØÑÑ-1000,
ÂÏ-10, ÃÏ-20 and ÃÏ-40.
2.1. Gas - okisju etilena or a mix ABOUT (okis etilena +
Bromic methyl 1:2,5).
These substances are toxic. After sterilization it is necessary
To ventilate a premise.
2.2. Solutions of peroxide of hydrogen and nadkislot (naduksusnaja) 6 %
Í2Î2 t = 18? With τ = 6÷
t = 50? With τ =3÷.
Spend in the closed capacities from a glass, p/m or enamels.
3. Filtering - with the help membrannyh and deep filters for
termolabilnyh substances. Maximal O por.
Membrannye filters < 0,3ìêì. Pred sterilizing - one or 2
The prefilter with O por > 0,3 microns.
Ceramic and porcelain O por - 3 - 4 microns. Membrannye filters
"Vladipor" from acetate of cellulose such as MFA use for clearing
From fine impurity and microorganisms of solutions medicinal
Substances. ÌÔÀ-3 (O 0,25 - 0,35 microns) and MFA (O 0,35 - 0,45 microns).
4. Radiating - for products from p/m, disposable syringes,
Some medical products. Spend on scale - installations,
Accelerators elektronov, etc. sources ionized
Radiations.
