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For over 100 years, steam sterilization technology has been used to quickly and effectively sterilize items that can withstand high temperatures and moisture. As water in the vapor state, steam is readily available, easy to control, and non-toxic. These properties make steam sterilization ideal in medical device and pharmaceutical industries, which rely on robust, safe sterilization processes for many critical applications.
This practical guide explains how to implement and optimize steam sterilization in pharma and medical facilities.
Understanding Steam Sterilization
The autoclave sterilization process involves removing the air surrounding the objects in the chamber and allowing the steam to penetrate the surface of the items. The primary purpose of an autoclave is for each object to come in direct contact with the steam at the required pressure and temperature for the allotted time.
The four key parameters of pharmaceutical and medical device steam sterilization include:
- 01Steam: Steam can transfer heat more efficiently than air, and it is commonly used in the autoclave sterilization process to destroy various microorganisms.
- 03Temperature: Within the autoclave chamber, the temperature must rise to a level where bacteria, fungi, spores, viruses, and other contaminants cannot survive.
- 02Pressure: As an ideal gas, steam at a given temperature will always have the same predictable pressure. Autoclave sterilizers must be able to withstand various pressures. Sensing equipment should be able to read pressure consistently and verify that the steam is performing as expected.
- 03Temperature: Within the autoclave chamber, the temperature must rise to a level where bacteria, fungi, spores, viruses, and other contaminants cannot survive.
- 04Time: Varying lengths of time are needed to achieve complete sterilization. The rate at which contaminants get destroyed is expressed as time at the given stable sterilization temperature. The cycle length depends on the desired sterility assurance level (SAL) and load type.
Inside the chamber of an autoclave, pressurized steam attains a temperature of 250 ºF to 273 ºF (115 ºC to 134 ºC), which is considered hot enough to kill viruses, bacteria, and mold spores. A higher temperature shortens the time objects need to remain inside the chamber.
For instance, at a temperature of 250 ºF, objects must remain inside the autoclave chamber for 15 minutes to ensure full sterilization. At a temperature of 273 ºF, objects only need to stay in the chamber for three minutes.
Assessing Your Sterilization Needs
Even though all types of steam can effectively sterilize, not all steam is the same. Steam quality is determined by the purity level required by the end-use application. For example, pharmaceutical products must have a higher level of steam quality to ensure sufficient sterilization.
Steam must be free of debris, condensate, and other impurities. It must get as close to this ideal state as possible to be considered clean, pure, or filtered steam for applications that need it.
Since steam comes from boiled water, the common belief is that purified or distilled water will create sufficiently clean steam. However, the process is more complex, especially for pharma steam generation. Clean steam must maintain a high-quality state throughout the generation, application, and distribution of the steam. Pure steam must adhere to even stricter requirements.
The following key factors can significantly impact the quality of steam:
- Boiler feed water quality (treatment and processing)
- Steam distribution through the valves and pipes
- Performance of steam-generating equipment, including electric steam generators
A stainless steel generator vessel is needed to generate clean steam, and according to the National Boiler Code, the vessel must be supplied with DI and/or RO water that does not contain dissolved minerals.
Electric clean steam generators can be integrated within the framework of an existing sterilizing system either as standalone generators or to minimize footprint requirements.
Choosing the Right Electric Steam Generator for Your Facility
In an electric autoclave steam generator, electric heating elements heat the water and generate steam. The following types of electric generators are frequently used in autoclaves:
- Integral Boiler: These are typically mounted underneath the autoclave chamber at or below 45 kW and are available in carbon steel or stainless steel for clean steam applications.
- Remote Boiler: A remote boiler is best suited for large autoclaves with chambers measuring at least 24″ x 36″ x 60″ and greater than 45 kW. Because of the larger size, remote boilers must be remotely mounted in another room or next to the autoclave, not underneath. They are available in stainless steel and carbon steel construction.
Electro-Steam offers the Vblock Series, LB Series, and LG Series of electric steam generators in stainless steel or carbon steel. These units are simple to use and install, offering the following features:
- 208, 240, 380, and 480 voltages
- Single- or three-phase connections
- Capacity range of 20 kW to 480 kW
Training Staff
Proper autoclave sterilization depends on accurate usage. Exposure to viable human pathogens creates a potential biological hazard. Due to the high pressure and heat created in an autoclave during operation, staff should receive training on the following measures to prevent burns and workplace accidents:
- Autoclaving preparation
- General precautions
- Incident response
- Operating parameters
- Proper loading and unloading procedures
- Record-keeping
Maintenance
In addition to monitoring water quality, staff should monitor and clean the generator, sterilizer, and water treatment equipment to maintain successful sterilization. Electric stainless steel generators require flushing at least once a week to prevent sludge and scale buildup. They should also undergo routine maintenance to meet the demands of CIP system pharmaceutical applications.
Request a Quote on Electric Steam Generators for Sterilization
Since 1952, Electro-Steam Generator Corp. has provided high-quality electric clean steam generators for a broad range of industries and applications. As an American-made original equipment manufacturer (OEM), we have the knowledge, expertise, and resources to deliver innovative solutions for cleaning and sterilization processes in the medical device and pharmaceutical industries.
We offer the benchtop LG Series, the larger, more powerful LB Series, and customization options to meet the needs of almost any application. Our highly efficient, high-quality clean steam units have 316L stainless steel construction, and most models are available in steam to indirect steam options to meet our customers’ specific needs, such as facilities that already have utility steam in place.
All Electro-Steam generators are proudly made in the USA by licensed boiler operators (New Jersey Department of Labor). They are constructed using the best quality parts and feature:
- Adjustable pressure controls
- Automatic low water cutoffs
- Safety valves
Our standalone models have stainless steel cabinets, and our integral units come with stainless steel electrical boxes. We offer two- to four-week production for most of our units and 98% efficiency ratings without the need to preheat the feed water. We also offer a standard five-year warranty on chambers and a one-year warranty on all other components.
Contact us today to learn more about our product line of top-quality standard and customizable electric steam equipment.
