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We answer the top questions being asked about autoclaves and the sterilization process.

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At Beta Star, our mission is to provide simple and reliable sterilization solutions. Delivering sterilization simply begins with a consistent understanding of steam sterilization solutions through the use of autoclaves, also called steam sterilizers. In preparing for this article, our team dove into Google’s online search results to identify seven of the most frequently asked questions related to autoclaves and the sterilization process they execute. 

1) Why is the standard autoclave temperature set to 121^oC?

Sterilization of media, the centric purpose of autoclaves, is designed to reduce the presence of live pathogens that could contaminate the development of pharmaceutical drugs, invalidate the results of research institutions, or allow outside pathogens into vivarium laboratories.

The death of the pathogen, whatever type it may be, is completed by the destruction of the structural and metabolic cell components required for replication. Without the ability to replicate or infect, the pathogen is no longer a threat to the environment around it. While specific pathogens or specific environments may require higher temperatures, 121^oC is widely held as the minimum temperature for efficient sterilization. 121^oC is necessary, because at 100^oC (the boiling point of water under unadulterated atmospheric conditions) endospores are not killed and thus sterilization cannot be fully achieved. In fact, Geobacillus stearothermophilus is used as an indicator to confirm that a successful sterilization cycle was completed. This answer is further vetted in conjunction with question number five.

2) Why are autoclaves being used for media preparation?

Autoclaves are used to prepare many different types of media for their final purpose. They are used to provide sterile media that may be consumed in different applications, such as in vivarium laboratories and food & beverage manufacturing. Media is also studied in microbiology laboratories, tested in innovative research institutions, and distributed for life-saving applications like pharmaceutical medicine or orthopedic facilities. The most important aspect of the autoclaves that deliver sterilization, are their ability to give a biological blank slate to the user. From this blank slate:

• Media (water, food, etc.) may be consumed safely without contaminants
• Studies may be completed without the altering presence of an unknown or uncontrolled pathogen
• Research tests can be completed and replicated, thus ensuring adoption and acceptance of the test results
• Providing life-saving applications, such as orthopedic devices or COVID-19 testing kits, that are packaged free from pathogens

3) Who invented the autoclave?

The first autoclave-like pressurized vessel, similar to what is now known as a pressure cooker, was built by Denis Papin in 1679! However, it would take another 200 years before the autoclave as we know it would be built. In 1879, Charles Chamberland, working Louis Pasteur (the inventor of the pasteurization process) created the first autoclave for medical and scientific purposes. Want to see a cool photo of a 115-year-old autoclave? Check out the photo of an autoclave built in 1905 by Northwestern Steel and Iron Works.

4) What are autoclave bags used for?

Autoclave bags are used to hold biohazardous items until it is time to be sterilized in an autoclave. The high-density propylene that they are typically made of can withstand temperatures up to 135^oC, the high end of nearly all autoclave cycle parameters.  When searching for autoclave bags to use at your facility, it is recommended that the manufacturer of those bags meet the following regulations:

• Federal DOT Regulation 49 CFR 173.197
• ASTM D1922
• ASTM D1709

5) How does autoclave sterilization work?

Sterilization in an autoclave (often aptly referred to as a steam sterilizer) works through the manipulation of four aspects vital to effective sterilization: time, temperature, pressure, and steam. They all play an important role in the process of effective sterilization:

• Time: Proper time ensures that the pathogens have been in the presence of a sterilizing environment (steam at temperature) for a long enough time to facilitate the proper killing of all pathogens.
• Temperature: Proper temperature of the steam that comes in contact with all pathogens, a minimum of 121°C, ensures the proper destruction of the pathogen’s ability to reproduce.
• Pressure: Manipulating the pressure in an autoclave’s prevacuum cycle ensures that no air pockets are left remaining in the sterilizing chamber. Air pockets provide insulation to pathogens from the sterilizing environment and are removed during pressure ramping so that the pathogens do not escape proper sterilization.
• Steam: Transfer of heat is most efficiently done using steam. The steam fills the chamber so that it can come in contact with the entirety of the sterilization load.

6) What are autoclaves used for?

At a foundational level, autoclaves are used to execute the steam sterilization process. They are designed to kill 99.9999% of all pathogens after a successful sterilization cycle is run. This is commonly referred to as a 6-log reduction in living pathogens. For the respective industries that we operate in, autoclaves are commonly used for:

• Biomedical / Pharmaceutical: In these laboratories, autoclaves are frequently used for the research development of drugs and vaccines.
• Common Laboratory (Research): in these laboratories, research tools and instruments are the most frequently autoclaved items.
• Vivarium: to maximize throughput, bulk autoclaves are used in vivarium facilities to sterilize cages and bedding for the protection of research subjects.

7) Can autoclaves kill viruses?

Autoclaves are capable of killing all types of pathogens, including viruses through the effective use of the four tools for sterilization mentioned in the answer to question 5. This has become especially poignant as the world grapples with the COVID-19 pandemic. Killing viruses are important in some applications for sterilizing medical tools and PPE before they are discarded.

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Sources

(Question 1) Science Direct
(Question 1) National Center for Biotechnology Information (NIH)
(Question 3) Smithsonian Institute
(Question 4) Tufpak
(Question 5) CDC

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Unique Customer Problem: Unnecessary Utility Consumption

For a recent customer, we supplied an equipment package of 11 autoclaves, varying in sizes from 20” x 20” chambers to bulk chambers, for a new state-of-the-art vivarium laboratory at a renowned medical school in the South Central US. The Beta Star team, with it’s raw plate to FAT approach, completed the design and manufacture at it’s company headquarters. Using company monitored warehouse space, Beta Star was able to store the sterilizers until the new building was completed.

After sterilizer installation and user training was completed, an issue which drove a significant increase in heat loss to room. In the bulk autoclave room, a vent fan was installed to pull out the heat released to the room once the sterilizer door is opened upon cycle completion. As designed, this step was a manual process that had to be written into the customer’s Standard Operating Procedures and executed by the laboratory technician. Not only was this process dependent upon manual execution after cycle completion and door unseal, it required that all cycles be completed during working hours to effectively mitigate heat loss to room. In addition, it frequently became a missed step for the laboratory technicians, who were rightly focused on conducting and monitoring their research.

The Beta Star Solution: Building Management System (BMS) Integration

From the outset of problem discovery, the customer and Beta Star’s Controls Engineering Team goal was to automate the fan operation to reduce utility consumption generated by the sterilizer’s heat loss to room. The custom developed plan, spearheaded by the Controls Team, created a connection between the new facility’s Honeywell Building Management System (BMS) and the Allen Bradley PLCs that power all Beta Star sterilizers. Through this connection, the exhaust fan system in the bulk sterilizer rooms would start upon door release and operate for 15 minutes. All of the parameters, such as fan initiation and operation time, were customized to suit the customer’s desires, and are programmable through their in-house BMS.

Are you experience problems with sterilization facility processes? Looking for a way to automate process steps to free up your technicians to focus on the search? Get in touch with Beta Star for a review of your existing problems.

The Power of a Team

The power of a team, working in tandem with each other, is how great accomplishments in sport and in manufacturing are achieved. In sport, the head coach of Duke Men’s Basketball Team, Mike Kryzyzewski, has led one of the most successful college basketball programs of all time. In fact, under his leadership, the Duke Team has won the 4^th most NCAA Basketball Championships of all time! During that time, he has coached many remarkably talented individuals who went on to become recognized worldwide for their individual success.

For a recent project providing seven different sterilizers to a customer producing pharmaceutical grade solutions for the research industry, the Beta Star division, support by parent company R-V Industries, successfully leveraged the breadth of our resources to satisfy our customer’s unique sterilization demands. This interconnectedness was essential to maximize the production process as, on one’s one, a project that would have taken over half a year to manufacture, assemble, and ship, was scheduled to be completed in 2 months of manufacturing time. Take a look inside our “Raw Plate to FAT†Sterilizer Production Process on a recent project with seven different sterilizers:

Engineering and Design

Though many of our customers select sterilizer models from industry standard lines, the Beta Star production process begins with the engineering department. For this particular project, documented engineering control and justification for machine design is a vital step in the process of creating seven sterilizers that will adhere to the guidelines that pharmaceutical customers are held to. For more on those guidelines, visit our post about the pharmaceutical machine guidelines.

At this stage, a Bill of Materials is established for every component used in the manufacturing of the sterilizer machine and a completed Piping and Instrumentation Drawing (P&ID) is created for customer sign-off to ensure the marriage of machine design and customer expectations.

INVENTORY MANAGEMENT TEAM

As a manufacturer and service provider, Beta Star keeps significant inventory levels to manage high demand production times, and overnight shipping service and parts needs. The production process, for a run of numerous sterilizers such as the project mentioned above, starts with our non-proprietary components, which ensure cost efficient part replacements throughout the life of the sterilizer. For this project, members of the inventory control team pulls and delivers all parts from the Bill of Materials generated form engineering, to the proper production team members to keep the manufacturing and assembly process as efficiently as possible.

PRODUCTION PLANNING AND MATERIAL MANAGEMENT

Production Planning and Material Management teams take over the next stage in the Plate to FAT production process. At this stage, the fabrication schedule is carefully planned out for the following weeks and months to ensure on-time delivery. To prevent the collateral damage of delays in any stage of the production process, a team meeting establishes department level deadlines where individual accountability is accepted.

PLATE BURNING AND BENDING

At this stage, the raw plate to FAT process officially begins. The first step is to take the raw plate, consisting of 316 and 304 stainless steel, and use our highly specified table burner to cut pieces for the formation of the sterilization chamber, jacket, and doors.

After the pieces are cut, the plate bending team utilizes our in-house bending machinery to form the pieces previously cut to match the specification drawings. At this stage the pieces begin to take shape and resemble the sterilization chamber, jacket, and doors seen at the finished product. To bend stainless steel, at a common dimension of ½ an inch, the bending machines must use a minimum of 87.89 tons of pressure to create the angles to build the sterilizer essentials (chamber, jacket, and doors).  

PRE-FABRICATION AND WELDING

The next step in the process is the pre-fabrication of the sterilizer essentials. To protect the material integrity from cross contamination with non-stainless-steel material, all pre-fabrication and welding tasks are completed in our 26,000 square foot stainless and alloy only facility. Protecting stainless steel material from cross contamination is important to protecting the lifespan of the sterilizer, as any contaminants from carbon steel grades can cause rusting and degradation of the chamber and door surfaces.

At the pre-fabrication step, skilled employees fit the previously cut and bent pieces together and tack weld those pieces to each other to hold the pieces in properly alignment and positioning. After pieces of the sterilizer are tack welded, final welding is completed utilizing our vast array of over 300 certified weld procedures for all types of material including 304 stainless steel, 316 stainless steel, and 2205 duplex stainless steel.  To ensure the quality of these welds, our sterilization chambers will be hydro-tested to spot any structural deficiencies in the finished product.

MECHANICAL AND ELECTRICAL ASSEMBLY

The final and critical step of the sterilizer production process before shipment is the mechanical and electrical assembly. The mechanical assembly team completely fits out a raw chamber with the piping and valve systems to create a fully functioning sterilizer. However, to get the sterilizer to function, it requires the electrical assembly and controls engineering teams to engineer and connect the PLC and HMI to power the sterilizer. Through dozens of hours, these two assembly teams create a functional sterilizer that is ready for Factory Acceptance Testing before it moves to the final stage of the process.

SHIPPING AND LOGISTICS

Bolstered by the support of an in-house fleet of logistics, trucking, and packaging professionals, we are able to ensure that our sterilizers are properly packaged and delivered to the proper facility at the right time. To facilitate unexpected delays in new construction and renovation projects, we offer climate controlled warehouse storage as an option to keep customer workplaces free of the barriers of large sterilizers.

THE POWER OF TEAM

Through the vastness of all of our different engineering and production departments, a variety of different skills sets, mastered through years of years of experience, are brought together to create a batch of seven sterilizers for our customer. The professional level of experience is proven out by the fact that the average current employee at R-V Industries, parent company of Beta Star, is over 10 years. And together, this team bears proof that the quote of legendary Coach Mike Kryzyzewski is true.