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Cleaning Strategy / Sterilization / Autoclave / Glassware Washer
Sterilization (microbiology)
https://en.wikipedia.org/wiki/Sterilization_(microbiology)

Sterilization (or sterilisation), referring to any process that eliminates, removes, kills, or deactivates all forms of life and other biological agents (such as fungi, bacteria, viruses, spore forms, prions, unicellular eukaryotic organisms such as Plasmodium, etc.) present in a specified region, such as a surface, a volume of fluid, medication, or in a compound such as biological culture media.[1][2] Sterilization can be achieved through various means, including: heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization in that sterilization kills, deactivates, or eliminates all forms of life and other biological agents which are present.

Front-loading autoclave

Applications:
 
Foods:
One of the first steps toward sterilization was made by Nicolas Appert who discovered that thorough application of heat over a suitable period slowed the decay of foods and various liquids, preserving them for safe consumption for a longer time than was typical. Canning of foods is an extension of the same principle, and has helped to reduce food borne illness ("food poisoning"). Other methods of sterilizing foods include food irradiation[3] and high pressure
(pascalization).[4]

Medicine and surgery:
In general, surgical instruments and medications that enter an already aseptic part of the body (such as the bloodstream, or penetrating the skin) must be sterile. Examples of such instruments include scalpels, hypodermic needles and artificial pacemakers. This is also essential in the manufacture of parenteral pharmaceuticals.

Preparation of injectable medications and intravenous solutions for fluid replacement therapy requires not only sterility but also well-designed containers to prevent entry of adventitious agents after initial product sterilization.

Most medical and surgical devices used in healthcare facilities are made of materials that are able to go under steam sterilization. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. Ethylene oxide gas has been used since the 1950s for heat- and moisture-sensitive medical devices. Within the past 15 years, a number of new, low-temperature sterilization systems (e.g., hydrogen peroxide gas plasma, peracetic acid immersion, ozone) have been developed and are being used to sterilize medical devices.][5] 


Joseph Lister was a pioneer of antiseptic surgery
.
Steam sterilization is the most widely used and the most dependable. Steam sterilization is nontoxic, inexpensive, rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics.[6]
Quantification
 

The aim of sterilization is the reduction of initially present microorganisms or other potential pathogens. The degree of sterilization is commonly expressed by multiples of the decimal reduction time, or D-value, denoting the time needed to reduce the initial number  to one tenth () of its original value.[8] Then the number of microorganisms  after sterilization time  is given by:
.

The D-value is a function of sterilization conditions and varies with the type of microorganism, temperature, water activity, pH etc.. For steam sterilization (see below) typically the temperature (in °Celsius) is given as index.

 
Theoretically, the likelihood of survival of an individual microorganism is never zero. To compensate for this, the overkill method is often used. Using the overkill method, sterilization is performed by sterilizing for longer than is required to kill the bioburden present on or in the item being sterilized. This provides a sterility assurance level (SAL) equal to the probability of a non-sterile unit.
For high-risk applications such as medical devices and injections, a sterility assurance level of at least 10−6 is required by the United States Food and Drug Administration (FDA).[9]

Steam(Moist heat sterilization)
https://en.wikipedia.org/wiki/Sterilization_(microbiology)#Heat
https://en.wikipedia.org/wiki/Moist_heat_sterilization
A widely used method for heat sterilization is the Autoclave, sometimes called a converter or steam sterilizer.
Autoclave :
https://en.wikipedia.org/wiki/Autoclave
An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different from ambient air pressure.
Autoclaves are used in medical applications to perform sterilization and in the chemical industry to cure coatings and vulcanize rubber and for hydrothermal synthesis. They are also used in industrial applications, especially regarding composites, see autoclave (industrial).

Cutaway illustration of a jacketed rectangular-chamber autoclave
Action on micro-organisms
Moist heat causes destruction of micro-organisms by denaturation of macromolecules, primarily proteins. Destruction of cells by lysis may also play a role. While "sterility" implies the destruction of free-living organisms which may grow within a sample, sterilization does not necessarily entail destruction of infectious matter. Prions are an example of an infectious agent that can survive sterilization by moist heat, depending on conditions.
Many autoclaves are used to sterilize equipment and supplies by subjecting them to high-pressure saturated steam at 121 °C (249 °F) for around 15–20 minutes depending on the size of the load and the contents.[1] 
The autoclave was invented by Charles Chamberland in 1879,
[2] although a precursor known as the steam digester was created by Denis Papin in 1679.[3] The name comes from Greek auto-, ultimately meaning self, and Latin clavis meaning key, thus a self-locking device.[4]
 
Air removal:

It is very important to ensure that all of the trapped air is removed from the autoclave before activation, as trapped air is a very poor medium for achieving sterility.
Steam at 134 °C can achieve in three minutes the same sterility that hot air at 160 °C can take two hours to achieve.
[8] Methods of air removal include:

Downward displacement (or gravity-type):
As steam enters the chamber, it fills the upper areas first as it is less dense than air. This process compresses the air to the bottom, forcing it out through a drain which often contains a temperature sensor. Only when air evacuation is complete does the discharge stop. Flow is usually controlled by a 
steam trap or a solenoid valve, but bleed holes are sometimes used, often in conjunction with a solenoid valve. As the steam and air mix, it is also possible to force out the mixture from locations in the chamber other than the bottom.

Steam pulsing:
air dilution by using a series of steam pulses, in which the chamber is alternately pressurized and then depressurized to near atmospheric pressure

Vacuum pumps:
 vacuum pump sucks air or air/steam mixtures from the chamber. (Explained here).

Superatmospheric cycles:
achieved with a vacuum pump. It starts with a vacuum followed by a steam pulse followed by a vacuum followed by a steam pulse. The number of pulses depends on the particular autoclave and cycle chosen.

Subatmospheric cycles:
similar to the superatmospheric cycles, but chamber pressure never exceeds atmospheric pressure until they pressurize up to the sterilizing temperature.
   

Uses :  In medicine
A medical autoclave is a device that uses steam to sterilize equipment and other objects. This means that all bacteria, viruses, fungi, and spores are inactivated. However, prions, such as those associated with Creutzfeldt–Jakob disease, may not be destroyed by autoclaving at the typical 134 °C for three minutes or 121 °C for 15 minutes.[citation needed] Although a wide range species of archaea, including Geogemma barosii, can survive at temperatures above 121 °C, no archaea are known to be infectious or pose a health risk to humans; in fact their biochemistry is so vastly different from our own and their multiplication rate is far too slow for microbiologists to worry about them.

Autoclaves are found in many medical settings, laboratories, and other places that need to ensure the sterility of an object. Many procedures today employ single-use items rather than sterilizable, reusable items. This first happened with hypodermic needles, but today many surgical instruments (such as forceps, needle holders, and scalpel handles) are commonly single-use rather than reusable items (see waste autoclave). Autoclaves are of particular importance in poorer countries due to the much greater amount of equipment that is re-used. Providing stove-top or solar autoclaves to rural medical centers has been the subject of several proposed medical aid missions.[citation needed]


Because damp heat is used, heat-labile products (such as some plastics) cannot be sterilized this way or they will melt. Paper and other products that may be damaged by steam must also be sterilized another way. In all autoclaves, items should always be separated to allow the steam to penetrate the load evenly.
Bio-Hazards:
Autoclaving is often used to sterilize medical waste prior to disposal in the standard municipal solid waste stream. This application has become more common as an alternative to incineration due to environmental and health concerns raised because of the combustion by-products emitted by incinerators, especially from the small units which were commonly operated at individual hospitals. Incineration or a similar thermal oxidation process is still generally mandated for pathological waste and other very toxic and/or infectious medical waste.
In dentistry, autoclaves provide sterilization of dental instruments according to health technical memorandum 01-05 (HTM01-05). According to HTM01-05, instruments can be kept, once sterilized using a vacuum autoclave for up to 12 months using sealed pouches.[9]

Validations

To facilitate efficient sterilization by steam and pressure, there are several methods of verification and indication used; these include color-changing indicator tapes and biological indicators. When using biological indicators, samples containing spores of heat-resistant microbes such as 
Geobacillus stearothermophilis are sterilized alongside a standard load, and are then incubated in sterile media (often contained within the sample in a glass ampule to be broken after sterilization). A color change in the media (indicating acid production by bacteria; requires the medium to be formulated for this purpose), or the appearance of turbidity (cloudiness indicating light scattering by bacterial cells) indicates that sterilization was not achieved and the sterilization cycle may need revision or improvement.

Directives / Standards / Certifications
CE PED: Pressure Equipment Directive
https://en.wikipedia.org/wiki/Pressure_Equipment_Directive
EN ISO 9001: Quality management systems standards
https://en.wikipedia.org/wiki/ISO_9000
BS OHSAS 18001:Occupational Health and Safety Assessment Series
https://en.wikipedia.org/wiki/OHSAS_18001

ASME: American Society of Mechanical Engineers
https://en.wikipedia.org/wiki/ASME

UNI EN ISO 14001: Environmental audit
https://en.wikipedia.org/wiki/Environmental_audit

EN ISO 13485 : Medical devices -- Quality management systems
https://en.wikipedia.org/wiki/ISO_13485
EN 285: Sterilization - Steam sterilizers - Large sterilizers
http://www.din.de/en/meta/search/61764!search?query=en285
DIN 58951-2: Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
http://www.din.de/en/meta/search/61764!search?query=DIN+58951-2
VDI 6300 Blatt 1: Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
http://www.din.de/en/wdc-beuth:din21:249728861

HTM 2010: Health technical memorandum 2010 :Part 3: Validation and Varification - Sterilization
https://www.gov.uk/government/collections/health-technical-memorandum-disinfection-and-sterilization
TRB402/DIN EN 61010-2-040 : Thermolock for the sterilization of liquids Safety requirements
http://www.din.de/en/

Applications
 
Bio-pharmaceutical Packaging Food Cosmetics Microbiology

Loads:

Machine parts, Large volume parenterals, Syringes, Blood bags, Glassware, Sealed & unseald containers, Garments, Wrapped tools, Culture media, Tools, Canned food.

User groups:
Microbiology and analytical labs
Research institutes, examination agencies, universities and high schools
Bio-Technologies and life sciences institutions
Clinical diagnostic labs, Hospital operating theaters and medical care, clinical diagnostic labs
Agriculture, environmental and veterinary labs,  Animal facility
Material testing laboratories
 Quality control labs in pharma, food/beverage, chemistry/cosmetics and other industrial sectors.

High Performance Autoclaves Key features:

Standard & Certifications:
cGLP compliance, compatible data management.
Comply BSL3–BSL4 laboratory risk category and for operating theater.
Satisfies the most rigid requirements of safety and quality according to international standards.
The operating software is fully validated and documented.
Optimized loading for Waste with high pathogen risk, and sealed containers.
Single or double doors for Pass-Through regulation and applications.
Engineered and pre-validated according to GAMP5.
Fully validated and documented.
Experience in the pharmaceutical industry across 60 years of history.

System controls:

Industrial microprocessor, graphic LCD, key pad.
Close loop feedback PID algorithm, significant energy saving.
Continuous and accurate control of chamber temperature and pressure.
Industrial lab process controller, high process reliability.
Exclusive pressure and temperature dual sensor system, double regulation and control of the sterilization process.
High level, fully programmability and control versatility, 30 cycles easy to customize in a multi-user environment. 


Sterilizing Chambers & Lids:
Volume ranges: 30L, 45, 50, 75, 140, 147, 210, 325, 456, 481, 590, 615, 700, 730 Liters.
High tech chamber and door construction.
Top AISI 316L Stainless Steel, electro, mirror polished sanitary finishing.
AISI 304 Stainless Steel steam recovery tank.
Temperature ranges and High-pressure: 3,5bar, 100 °C-144 °C, customizable.
Internal 316Lss heat-exchanger plates for chamber pre-heating by steam, and cool down by cold softened water.
Optionally these plates can be used for drying purposes at the end of the cycle.
Energy and water cost-saving. Small foot print with superior loading capacity.

Chamber Lids:

Automatic independent operation and control.
Patented pneumatic lid sealing, assuring maximum safety.
Dedicate buffer air compressor for lid closing and final drying.
Lid with quick closing and safety interlocks.
Exclusive patented swiveling pneumatic gasket"rotate-and-seal"for horizontal lid.
Guarantees perfect airtight, maximum reliability.
Improved safety and easy maintenance.
Can be equipped with safety device in compliance with TRB402/DIN EN 61010-2-040 and thermal interlock to prevent door open Internal heat exchanger for lid rapid cooling.
Pneumatically activated Sliding doors for space efficiency.
Single/double Stailess Steel sealing flange (BIOSEAL) 

Steam generator:

Built-in with aut- water feed pump.
Heat recovering system for water preheating.
Assuring utilities cost saving.
Steam heat recovery exchanger external to chamber for preheating and reusing water.

Filetrs:

Vertical position, avoiding frequent rupture.

Components:

Sanitary pneumatic diaphragm valve.
AISI 316L stainless steel components.
Electropolished mirror finished chamber.
AISI 316Lss internal heat exchanger for Chamber Lid.
Chemical inert insulation, both thermal and acoustic smoother, quieter and safer operations.

User flexibility and interfaces:

Quick connections to all utilities for easy handling and installation.
Ergonomically designed chamber for maximizing loadable capacity.
Ergonomic features for easy handling and daily use.
Ergonomic positioning of adjustable operator display.
Ideal positioning of operator's panel and printer.
Optimized loading height from floor.
Timed free steaming with pulses for effective air removal.
Conceptual design and modular construction with exclusive optional kits.
Set of four castors for easy moving and installation in lab room.
Easy to configure, 14 free configurable automatic programs.
Multilevel passwords protected key-users access to ensure process safety.
For remote monitoring via Ethernet protocol.
Special test programs for routine check of sterilizer efficiency

Technical service area:

Access by a wide front door with a special safety lock for easy maintenance.
Full and easy accessibility to technical area from front and lateral sides.

Integrations:

Easy installation and quick connection to the utilities.
Innovative and unique modular design.
Wide selection and configurations of options on a modular system.
External trolleys fully compatible with Glassware Washer assure cleaning integration.
Integrated software and Process controller for glassware washers steam sterilizers, making training and maintenance easier.

Glassware Washer:

The power of steam: a cost-effective cleaning:
Optimized emollient effect on greasy and sticky dirt.
Significantly reduces operating costs
True eco-friendly solution, minimize detergents, water consumption, Lowering the running costs per cycle.
Able to access hard-to-reach areas and therefore clean thoroughly.

Continous monitoring:
Drain water conductivity purity set-point further reducing water and other utilities consumption.
The cleaning process is constantly supervised.
Dedicated probes monitoring the temperature of the air/water and of the steam in chamber.
A dedicated trasducer controls the pressure of the circulating water.
An internal LED lamp operates and signals alarm evidents by changing color during the whole cycle.
 

Design and technical features:
All compliant with cGLP standards.
Process controller, engineered and pre-validated according to GAMP5.
Rigorous sanitary finishing of piping and all equipments and CIP to ensure a perfect washing.
Standard or customized modular racks for loads configurations and pipe connection.
Easy and friendly ergonomic loading height, process controller.
Interchangeable external trolleys compatible with paralleled lab sterilizers.
Integrated software and Process controller for glassware washers steam sterilizers, making training and maintenance easier.



Global distribution locations:

White Papers
:
Technical Report No. 29 (Revised 2012) Points to Consider for Cleaning Validation

https://store.pda.org/tableofcontents/tr2912_toc.pdf
Continued process verification
https://en.wikipedia.org/wiki/Continued_process_verification
Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants
http://www.chromnet.net/Taiwan/Cleaning Strategy/APIC_Cleaning_Validation_2014.pdf
 


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