Types of sterilization packaging and their storage methods.

The main function of packaging is to protect sterile material from re-suspension by microorganisms (recontamination). Unwrapped sterile material is useless because it is not sterile. Products sterilized without packaging must be used immediately after sterilization. Sterilization with dry heat or wet material in a package helps to keep products sterile. Sterilization packaging materials should be easily permeable to the appropriate sterilizing agents, closed impermeable to microorganisms and maintain integrity after sterilization by an appropriate method.

For packaging we use reusable sterilization bins (boxes), different Kraft bags, modern packing materials.

Sterilized are dry products in packages of unimpregnated paper (Kraft-packages), wet sack paper. There are packages of double-layer cotton fabric corresponding to OST 42-21-2-85. Shelf life of sterility depends on packaging. Bix without filter are stored for three days, with a filter. 20 days. Packages made of double-layer x-woven fabric conforming to OST 42-21-2-85.-б. Tissue or kraft bags can be stored for up to three days in sterile conditions. All packages are marked.

Three varieties of pouches are manufactured according to the chemical indicator:

-with chemical indicator of steam sterilization ISPS

-with chemical indicator of air sterilization ISPS.

-with a chemical indicator of steam and air sterilization IE “VINAR”

Since 1998, the Ministry of Health authorized the use of imported paper bags meeting international standards. Shelf life of such pouches is 20 days. Self-adhesive bags made of moisture-resistant paper for steam and air sterilization are used today. On the outside of the package is printed chemical indicator of class 1 with the indication of the corresponding sterilization method and the description of the final color of the indicator to be acquired after sterilization. The bags are hermetically sealed with self-adhesive tape on the pouch flap without any additional equipment.

Storage of products sterilized in packaged form in cabinets, workbenches. Storage times are indicated on the package and depend on the type of packaging material according to the instructions for its use.

Type of package	Shelf life of the pouches before package opening	Shelf life after package opening
Bix with bactericidal filter (BFSC)	20 days filter change for 21(61) sterilization	6 hours
2-layer calico	3 days	6 hours
Kraft bag	20 days
Combination packs (plastic-pergament)	20 days for adhesive tape; 4 to 6 months for rolled or self-adhesive
Moisture-proof paper-package	20 days

The main function of packaging is to protect sterile material from re-insemination by microorganisms (recontamination). Without packaging, sterile material is useless, because it is not sterile. Products sterilized without packaging must be used immediately after sterilization. Sterilization with dry heat or moist material in a package helps to maintain sterility of products. Sterilization packaging materials must be easily permeable to the corresponding sterilizing agents, closed impermeable to microorganisms and maintain integrity after sterilization using an appropriate method.

For packaging we use reusable sterilization bins (boxes), different Kraft bags, modern packaging materials.

Dry products in packages of unimpregnated paper (Kraft-packages), water resistant paper sacks are subject to sterilization. There are double-layer cotton pouches conforming to OST 42-21-2-85. Shelf life of sterile depends on packaging. Bix without filter are stored for three days, with filter. 20 days. Packages made of double-layer x.-б. Cloth or Kraft bags are stored for up to three days in sterile conditions. All packages are labeled.

Depending on the chemical indicator the packages are made in three varieties:

-with the chemical indicator of steam sterilization ISPS

-with the chemical indicator of air sterilization ISPS.

-with chemical indicator for steam and air sterilization IE VINAR

Since 1998, the Ministry of Health has authorized the use of imported paper bags that meet the requirements of the international standard. Shelf life of such packages is 20 days. Today we use self-adhesive pouches made of moisture-proof paper for steam and air sterilization. Applies a grade 1 chemical indicator on the outside of the pouch indicating the appropriate sterilization method and describing the final color of the indicator to be acquired after sterilization. The bags are hermetically sealed with self-adhesive tape on the pouch flap without using any additional equipment.

Products sterilized in packaged form are stored in cabinets, work tables. Storage times are indicated on the packaging and are determined by the type of packaging material according to the instructions for its use.

Kraft bag for sterilization. An ingenious way to keep items sterile

The choice of sterilization bag depends on the equipment in which the instruments are to be sterilized. Kraft bags for sterilization of instruments are divided into several categories:

• For steam sterilization. They are products made of paper on one side and transparent film on the other. Suitable for use in pressure cooker sterilizers.
• For air sterilization. Made entirely of paper. Used for sterilization through hot air. the instrument is placed in an oven and disinfected at 180-200C.
• Universal.

They can also be differentiated by color (white or brown), self-adhesive tape, method of sealing, presence and type of indication, and many others. But the main difference is in the sterilization conditions.

Types and Applications

Kraft pouches for sterilizing medical instruments like syringes, pipettes, tubes, scalpels, tweezers, etc.

For sterile packaging of medical instruments and materials.

For sterilization, packaging of tools and materials of chemical, pharmaceutical industry.

For hermetic packaging of food products.

For packing of various industrial products.

Kraft bags with handles and logos. one of the means of advertising companies.

Indicator will change color depending on the sterilisation method:. For air sterilisation (sterilization in a drying cabinet) the color of the indicator on the bag should change from pink to brown;. With steam (autoclave sterilization). from pink to gray.

Before sterilizing, I put the instruments in kraft bags. They have a special indicator on them, which shows that the tool is sterile. Indicator is beige when the bag is put in the oven and purple when it is taken out. The client can be guided by it. told the master of manicure Inna I.

Place instruments in self-adhesive kraft sterilization bags and seal them. Sterilize instruments in a dry oven at 180°C, for 1 hour. Do not exceed specified temperature and holding time!

White pouches are more expensive than brown pouches but don’t release odors during sterilization. Suitable for sterilization. 350 R Vinard Brown Paper Kraft pouches for dry-heat sterilization which keep your instruments sterile and keep germs out when closed, preventing recontamination.

The indicator changes color depending on the sterilization method:. The color of the indicator on the bag should change from pink to brown when using the air method (sterilization in a dry oven);. When steam sterilized (autoclave sterilization). from pink to gray.

White pouches are more expensive than brown pouches, but do not emit odors during sterilization. Suitable for sterilization. 350 P Vinard “Sterit” brown paper kraft pouches for dry-heat sterilization, keep instruments sterile and keep germs out when closed, preventing re-contamination.

Terms of storage of sterile materials in sterilisation boxes (beakers). 3 days. If this sterilization box has been opened, these materials are allowed to be used within 24 hours after opening (after which the side openings in the sterilization box must be opened).

Sterilizing Instruments

Shelf life of sterile materials depending on packaging.

Shelf life of sterilized products sterilized in sealed packaging in permanganate, sack paper, impregnated paper, sack paper moisture resistant, high strength paper, crepe paper, sterilization box with filter 20 days.

And in any hermetically sealed package and sterilization box without filter 3 days.

Brief usage of parchment, non-impregnated sack paper, waterproof sack paper and crepe paper up to 2 times, kraft paper up to 3 times (taking into account its integrity).

Products sterilized without packaging are placed on a sterile table and used within one work shift.

Shelf life of products sterilized in Kraft paper 3 days. The multiplicity of its use up to 3 times.

Period of storage of products sterilized and hermetically sealed in high-strength packing paper and creped paper 20 days. Frequency of use of moisture-resistant sack paper, crepe paper up to 2 times, high-strength packing paper up to 3 times.

Sterilization with chemical solutions.

Rinsed sterile products after removal of residual liquid from ducts and cavities, are used immediately as intended, or are stored in a sterile box laid out with a sterile sheet for not more than 3 days.

Products are sterilized in order to destroy all types of microorganisms, including spore forms.

All products that come into contact with the wound surface contacting with blood in the patient’s body or injected into it, as well as products that in operation come into contact with the mucous membrane and can cause damage to it are subject to sterilization.

STERILIZATION CONTROL OF MEDICAL PRODUCTS AT HOSPITALS AND CLINICS

The sterilization process is controlled by physical, chemical, and biological methods of control.

• provides for control of sterilization parameters­The following items must be installed on all medical equipment (timers, temperature, pressure and relative humidity sensors, etc.)­The equipment (timers for temperature, pressure and relative humidity sensors, etc.); the mucous membranes and all other apparatuses and fittings.);

• is carried out by an operator operating the sterilization equipment;

• should be carried out daily during each sterilization cycle;. sterilization control is carried out by the operator operating the sterilization equipment­The equipment (timers, temperature, pressure, relative humidity sensors, etc.);. sterilization;

• allows you to quickly identify and correct abnormalities in the operation of sterilization equipment.

A disadvantage: It evaluates the effect of the parameters inside the chamber of the apparatus, not inside the sterilizable package­The principle of action of the chemical indicators is based on changes in the aggravation of the chemical environment and should therefore be used in conjunction with other measuring systems­internal control methods.

• necessary for rapid monitoring of one or more of the following parameters­A disadvantage of the method: It only evaluates the effect of the parameters inside the chamber of the apparatus and not inside the sterilized packagings;

• The chemical indicators should be used daily for each sterilization cycle­A disadvantage of the method: It evaluates the action of the parameters within the chamber rather than within the packaged goods and the sterilization cycle;

Conducted with chemical indicators (see Single Crystal Method, page 48). The two types of sterilization are strictly specific to each type of indicator (see the classification of chemical indicators). The principle of action of the chemical indicators is based on changes in the ag­The principle of action of the chemical indicators is based on the change in the state of the indicator substance and/or the color of the indicator dye when certain parameters are acted upon­Two types of chemical indicators are distinguished by the principle of their placement on the objects to be sterilized: a sterilization regime which is strictly specific to each type of in­Depending on the sterilization method and regime, two types of chemical indicators are distinguished according to the principle of the placement of the indicators on the sterilized objects­internal and external.

External indicators (tapes, stickers) are lipped­A chemical indicator on the surface of the package used (paper, metal, glass, etc) can be used as a external indicator. д.) and subsequently removed. Certain packaging materials (e.g. plastic and paper bags, rolls) containing a chemical indicator on their surface may also be externally indicator.

Internal indicators are placed inside the package of sterilized materials, regardless of its type (paper or plastic bag, metal container, etc.).). These include various types of paper tracers, such as­The paper coating containing the indicator ink on its surface can be removed afterwards.

Depending on the number of parameters to be monitored­A distinction is made between several classes of chemical indicators. The higher the class, the more sterilization cycle parameters it controls­The higher the number of parameters monitored and the more likely it is that sterile materials will be contaminated, the higher the likelihood of obtaining sterile samples­When they are used.

Class 1. Indicators of the sterilization process. External in­Indicators designed for use on individual packages of sterilizable mammals­The indicators are designed to be used with. The results of the decoding allow us to conclude that the package in question has been sterilized­concentrations (e.g., reaching a certain level of sterilization or a certain temperature at which the instrument (material) has been sterilized)­The selected method and thus distinguish it from the unprocessed one.

Class 2. Indicators of one variable. The results of the decoding allow us to conclude that this package is designed for the operational control of ONE of the factors­Indicator of the concentration of a substance in a chemical solution (e.g., when a certain substance (material) has undergone sterilization)­The indicators are designed to measure the effect of ONE factor on the sterilization cycle, the temperature, the concentration of an actively­The multivariate indicators for the concentration of the active ingredient in a chemical solution, the concentrations of the­The gas and liquor control package is designed for the operational control of ONE gas or liquor source at a time. д.).

Class 3. Multiparameter indicators. intended­The indicators are designed to evaluate the action of two or more of the sterilization cycle factors. They are labeled with an asterisk on the side of the instrument panel to indicate the active ingredient of the sterilization­The color of the indicator dye changes color only when simultaneously subjected to more than one steam bath­The following methods are used to control the sterilization process: physical, chemical and biological methods to control the parameters (e.g. temperature and time in air sterilization; temperature, exposure to saturated steam in the steam sterilization method; gas concentration and relative humidity in the gas sterilization method, etc.), temperature, exposure to saturated steam and relative humidity in the gas sterilization method, etc. д.). Class 4. Integrators. chemical indicators which are analogous to biological indicators. They are designed to be used under any steam or air sterilization conditions and show simultaneous checks on all sterilization parameters­the results are evaluated after the sterilization cycle has been completed, allowing conclusions to be drawn about the method chosen. The principle of action of the integrato­The principle behind chemical indicators is that the melting point of a chemical indicator, which is analogous to a biological indicator, is the same as the melting point of a given substance­The performance of the indicator is identical to that of the substance they contain­The death rates of spore forms of bacteria, which are test forms used in traditional biology­They can be used with any of the following:. sterile (non-sterile) indicators. Their advantage: they allow the user to draw conclusions about the method chosen­All types of chemical indicators should be used according to the guidelines approved by the Ministry of Health of the Republic of Moldova­They can be used with any steam or air sterilization regimes to simultaneously verify the sterility (non-sterile) of the materials and draw conclusions about the selected sterilization method.

All types of chemical indicators should be used in accordance with the instructions approved by the Ministry of Health of the Republic of Moldova­lyrics Belarus.

• is based on the death of spore forms of test cultures, specific­The sterilization process is carried out using the same physical and chemical methods as for each of the sterilization methods used;

• is intended to evaluate the sterility condition of the­The packaging materials are also approved for use;

• The packaging materials used for the sterilization process may be carefully selected to attest to the sterilization effectiveness of the chosen sterilization regimen­sterilization.

Biological indicators can be made in a variety of packaging materials, including cardboard, paper, metal, glass, cloth and plastics­boratorium conditions. They may also be used with sterilizing agents­The materials for any sterilization procedure must have the following characteristics­The biological indicators may be prepared in accordance with the guidelines for their use, approved by N43 of the Republic of Belarus­Belarus.

Packaging of materials. The packaging materials and equipment used for the sterilization process should be carefully selected and tested to ensure that the sterilization regime chosen is effective­Materials for any method of sterilization must have the following characteristics:

• Do not affect the quality of the sterilized objects;

• be permeable to sterilizing agents;

•Tightness up to the point of opening the package;

• Be easily opened without disturbing the aseptic safety of the contents.

A distinction is made between the following types of packaging material­There are the following types of packaging material, which can be used individually or in combination: paper, metal, glass, cloth, plastic, polyurethane, polypropylene, polyvinyl chloride, ethylene chloride, vinyl chloride, ethylene chloride, etc.

Packaging materials are divided into two categories: single­Single-use items (paper, paper and plastic mats, containers, etc.)­The products are sterile and reusable (containers).

Shelf life of items sterilized in sealed package in permanganate, sack paper, impregnated paper, sack paper, high strength paper, crepe paper, sterilization box with filter 20 days.

And in any sealed package and sterilization box without filter 3 days.

Short-term use of parchment, unimpregnated sack paper, moisture-resistant sack paper and crepe paper up to 2 times, kraft paper up to 3 times (taking into account its integrity).

Items sterilized without packaging are placed on a sterile table and used during one work shift.

Shelf life of products sterilized in kraft paper. 3 days. Frequency of its use up to 3 times.

Shelf life of products sterilized and hermetically sealed in high-strength packing paper, crepe paper 20 days. The frequency of use of moisture-resistant sack paper, crepe paper up to 2 times, high-strength packing paper up to 3 times.

Sterilization with chemical solutions.

Rinsed sterile products after removal of residual liquid from ducts and cavities are used immediately as directed or stored in a sterile box lined with a sterile sheet for up to 3 days.

Sterilization of products is carried out in order to destroy microorganisms of all kinds, including spore forms.

Sterilization is required for all products coming in contact with the wound surface contacting with blood in the patient’s body or injected into it by injection drugs, as well as for products which in operation come into contact with mucous membranes and may cause damage thereto.

STERILITY CONTROL OF MEDICAL PRODUCTS IN HOSPITALS

Physical, chemical and biological methods are used to control the sterilization process.

• sterilization cycle; to be carried out daily at every cycle of sterilization;. provides for monitoring the parameters of the steril­The sterilization equipment (timers, temperature sensors, etc.); allows the operator to quickly identify and correct any irregularities in the operation of the sterilization­The sterilization cycle must be carried out daily for each sterilization cycle.);

• The method is conducted by the operator who maintains the sterilization equipment;

• Should be performed daily with each steering cycle­The system also allows for the quick detection and correction of anomalies in the performance of sterilisation equipment;

• allows to identify and correct deviations in the performance of sterilization equipment in a timely manner.

Disadvantage of the method: it evaluates the effect of parameters inside the chamber of the apparatus, not inside the sterilizable packages­The chemical indicators are used (see “Chemical Indicators” in this section)­The sterilization cycle can be controlled by a number of different methods of control.

• is necessary for the operative control of one or more of the sterilization­The sterilization cycle must be monitored by a number of valid sterilization cycle parameters;

• Must be performed daily at every steering cycle­sterilization;

Conducted with the use of chemical indicators (see the classification of chemical indicators). Classification of chemical indicators). The principle of action of chemical indicators is based on the change in ag­The two different types of chemical indicators are distinguished by the principle of their location on the objects to be sterilized: ) internal indicators and (or) the color of the indicator color under the effect of certain sterilization parameters­The two types of chemical indicators are differentiated according to the principle of their location­Depending on the sterilization method and regime, two different types of chemical indicators are distinguished according to the principle of their location on the sterilizable objects­external and internal.

External indicators (tapes, stickers) are lined with adhesive tape­The adhesive layer on the surface of the packages used (paper, metal, glass, etc.). д.) and are subsequently removed. External indicators can also be certain packaging materials (e.g. paper or plastic bags, rolls) which contain a chemical indicator on their surface.

Internal indicators are placed inside the package of sterilizable material, regardless of the type of package (paper or plastic bag, metal container, etc), and subsequently removed after the package is sterilized.). They include various types of paper indicators­The number of parameters monitored (e.g. attainment of a certain quantity of sterilization.

Depending on the number of parameters monitored­There are several classes of chemical indicators for the sterilization cycle. The higher the grade of the indicator, the more parameters of the sterilization cycle it controls­The more sterile the material, the more likely it is to be sterile­sterilized when used.

Class 1. Sterilization process indicators. external in­The higher the grade, the more sterilization cycle parameters are controlled by the indicator­teryals. The results of the decoding allow us to conclude that the packaging in question has a higher probability of being sterilized than the packaging in question­The number of parameters monitored during sterilization (e.g­The treatment with the chosen method and thus distinguish it from the untreated.

Class 2. Single variable indicators. are designed to monitor promptly the action of ONE of the factors­sterilization parameters (e.g. achieving a certain­The more often the dishwasher is used, the more often it needs to be cleaned­The principle of action of the integrating agent in a chemical solution, the concentration of the­Gas concentrations and t r a t i o n : gas concentrations and t r a t i o n : relative humidity. д.).

Class 3. Multivariable indicators. designed for­The principle of action of an integrating agent in a chemical solution in a concentration class 3. The chemical indicators are analogous to biological indicators­The color of the color indicator dye changes color only when several vapours are simultaneously applied­Multi-parameter gauges (e.g. temperature and time in air sterilization; temperature, saturated steam exposure in steam sterilization; gas concentration and relative humidity in gas sterilization, etc.). д.). Class 4. Integrators. Chemical indicators, which are analogous to biological indicators. They are designed to be used in all modes of steam or air sterilization and monitor the simultaneous action of all parameters­They are designed for use in any steam or air sterilization mode and monitor the simultaneous action of all parameters for the selected method. The principle of action of the integrator­The reasoning behind this is that the melting point of the chemical vapour­of which substance contained in them, is indentical soon­The system is based on the death of spore forms of bacteria, which are test cultures used in traditional biology­Biological indicators. Their advantage: All types of chemical indicators should be used according to the instructions approved by the Ministry of Health of the Republic of Belarus­The results should be checked after the sterilization cycle is completed and allows conclusions to be drawn as to the effectiveness of the chosen sterilization regime­sterility (non-sterile) of the materials.

All types of chemical indicators should be used in accordance with the instructions approved by the Ministry of Health of the Republic of Moldova­They have the advantage of broadening the scope of the package of sterilization methods.

• The sterilization test is based on the death of spore forms from test cultures that are specific to each of the various sterilization methods used by the laboratory­The sterilization methods used are based on the death of the spore forms and test cultures which are typical for the sterilization methods used;

• The device is designed to evaluate the sterility status of the products­The biological indicators can be made in lasers of the materials used;

• The use of biologically produced indicators may be confirmed by the sterilization­sterilization.

Biological indicators can be made in the laboratory of the sterilization­sterile (non-sterile) conditions. Biological indicators may be made from materials used in the sterilization­The imported dipsticks are designed to assess the sterility of the products­The results are recorded after the sterilization cycle is completed, and conclusions can be drawn from the results of the sterilization procedure­Belarus.

Packaging materials. The packaging materials used can be used alone or in combination with other packaging materials­Materials for any sterilization method should have the following characteristics:

• Do not affect the quality of the sterilized objects;

• be permeable to the sterilizing agents;

•provide leak-tightness until the package is opened;

• Open easily without disturbing the asepticity of the contents.

A distinction is made between the following types of package materials, which are­The packaging materials used can be used alone or in combination of the following: paper, metal, glass, cloth, plastic, etc.

Packaging materials fall into two categories: one­for single use (paper, paper-plastic masks, etc.)­The packaging materials can be used alone or in combination: paper, metal, glass, cloth, plastic, in a metal belt sterilization box.

Shelf life of sterile materials.

The shelf life of sterile materials depends on the packaging:

· The packaging materials used may be used alone or in combination: paper, metal, glass, cloth, plastic, or in a sterilization box with a metal band	3 days
· In a sterilization box with a double bactericide filter on the lid	20 days
· in a sterilized stacking box in a double-layer calico package	used daily for three days
· in a double-layer calico package	3 days
in M-70A kraft paper bags with a sticky layer to cover it	20 days
· unpackaged on a sterile table	During the shift (6 hours)
· in cartridges on a sterile table	during the shift (6 hours)

Rules for storage and use of sterile material and instruments

Period of storage of sterile materials depends on packaging:

· In a sterilization box with a metal band	3 days
· in a sterilization box with double bactericide filter on the lid	20 days
· in a sterilization stacking box in a double-layer calico package	to be used every day for three days
· in a double-layer calico package	3 days
In M-70A Kraft paper bags with a sticky layer to cover it	20 days
· Without packaging on a sterile table	during the shift (6 hours)
· in cartridges on sterile table	during a shift (6 hours)