Industry experts are an important resource for packaging and packaging services. Between the in-house experts at MJS Packaging and those within our global network, you can rest easier knowing that you don&#;t have to know it all. With that in mind for this article, we have leaned on our network of experts and focused on getting you answers about bottle sterilization services.
Many products benefit from a rigorous bottle sterilization process. There are also products, like pharmaceutical packaging, that actually require it. Wherever your business falls on that spectrum, we know how helpful it can be to know your options and have your questions answered.
Here are several key questions we have explored to help get a better understanding. From the answers below to the follow-up questions and interest they inspire, we want to help you make an informed decision.
If you are using bottles and vials for either packaging or handling pure fluids, you must sterilize those bottles.
Keep in mind there are different levels of cleanliness. A bottle might be clean, but it could be clean and sterile. It doesn&#;t stop there though because your bottles may also need to be clean, sterile, and pyrogen-free. Removing pyrogens is serious business; pyrogens cover a broad range of contaminants that have the potential to make your consumers ill. The level of cleanliness needed really depends on the product being put into the bottle/vial, so be sure to get the right consultation and solutions specific to your needs.
There are many types of impurities with the potential to adversely affect consumers. To name a few, manufacturers should be careful to rid their packaging and product of fungi, bacteria, and other contaminants introduced during the manufacturing process. Bottle sterilization is a broad term for the processes that effectively kill or eliminate these transmissible agents.
Different circumstances require different bottle sterilization methods. They each have the ability to help rid a product of different types of contaminants and achieve different levels of cleanliness.
Specifically, manufacturers can employ both physical and chemical methods of sterilization. Heat sterilization is the most widely-used and reliable method. Other sterilization methods include gamma irradiation, electron beam (E-Beam) irradiation and Ethylene Oxide processing. We&#;ll explore the different methods in a future post.
This answer is a fairly quick one, but it also requires some consideration for your product and your specific circumstances. Glass containers are actually not the only type of containers that can be sterilized. The sterilization process can also be a good fit for some plastic containers.
It might sound like a good idea to use finely filtered air as a &#;pure&#; agent to remove contaminants, but we would never recommend it. Filtered air just doesn&#;t do a good job of removing fine particles. It also does not remove and release agents from the surfaces of bottles and vials.
Instead, you can count on methods like chemicals, dry heat, or steam, to remove contaminants. These methods work because they destroy, displace, and alter contaminants&#; physical properties so they release. You can then have impurities successfully removed and mitigate the risk to consumers.
When you contact MJS Packaging to order vials, bottles, and other containers, we take pride in getting you the right solution. We know that expert consultation can provide a huge difference in your ROI. We are proud to say this extends to the services we provide to customers, too!
Contact us today if you have more questions about bottle sterilization services. And when you place an order, be sure to let us know if this is a service you would like us to add on!
An autoclave is a specialized piece of equipment designed to provide a physical method for disinfection and sterilization. The process is achieved using a combination of steam, high pressure, and time. Steam is remarkably effective at transferring thermal energy (compared to dry air) and can sterilise a load at 121 °C in just 15 minutes.
The majority of glass laboratory bottles are suitable for autoclaving. However, it is important to take note of some key differences between the types of glass products used in the lab as well as best practice methods when carrying out an autoclave cycle. In this article we answer common questions with advice that will enable you to autoclave glass laboratory bottles safely.
Before autoclaving lab bottles, it&#;s important to consider the suitability of different glass and bottle types. Borosilicate glass bottles are safe to autoclave as the material has a very good resistance to thermal shock. There is a much higher risk of breakage when autoclaving laboratory bottles made from soda lime or flint glass and while it remains possible to autoclave bottles of this type, the material doesn&#;t possess the same safety margin.
Plastic coated laboratory bottles can also be autoclaved safely, however, the coating material is subject to hydrolysis by steam during the autoclave process, meaning they are typically able to withstand fewer autoclave cycles than uncoated glass bottles. You should not typically fill glass containers beyond 75% of the nominal capacity, as this allows for liquid expansion and possible foaming, preventing overflow. However, the safe filling capacity also depends on the nature of the liquid. Glass bottles containing water or aqueous buffers may be filled to the container nominal fill-line. Whereas bottles used to sterilize agar-based media should only be filled to 50% of the container capacity.
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Firstly, when operating an autoclave, it is advisable to wear personal protective equipment. To remove items, especially hot glassware, this should typically include full eye/face protection, closed-toe shoes, and heat-resistant gloves. Avoid over-stacking the autoclave to allow steam to circulate for an effective sterilization process. It is also advisable to ensure bottles have been cleaned before placing them into an autoclave. This will prevent any contaminant substances from baking onto the walls of the glass bottle.
"Large heavy bottles, such as 20L bottles, should also have a small amount of distilled water (WFI or purified) placed inside them to help generate steam when they are being sterilized dry (empty) in an autoclave".
When sterilizing or autoclaving bottles, the screw cap must be loosely fitted with a maximum of one turn applied. In a closed vessel, the contents will expand causing a large pressure difference (over 4 bar absolute) which may result in an explosive failure. In addition, caps that are not sufficiently unscrewed can create a vacuum in the bottle during the cooling phase.
If bottles are not properly vented, the liquid inside cannot boil during the re-cooling phase and thus will remain superheated for an extended time. Never seal or move containers of superheated liquids. If the cap is left loose (1/2 turn) then there is no pressure differential between the steam inside the autoclave and the inside of the bottle. Bottles may be safety autoclaved with sealed caps if the steam autoclave has support pressure compensation.
In conventional autoclaves (without pressure compensation), a membrane venting cap is a safer and convenient option. A two-way pressure equalization takes place through the 0.2 µm ePTFE membrane, while enabling the cap to remain tightly closed to reduce the risk of contamination after the autoclave process is complete. Membrane venting caps should not be used with bottles larger than mL.
For GMP operations, medical applications, or for bottles that are 5L or larger, the use of a single port connector cap fitted with a sterile venting filter would be a more suitable option than a membrane cap. For example, a single-port GL 45 stainless steel cap can be used with a validated pharma-grade sterile-air 0.2-µm 50mm disk or capsule filter. This option is especially recommended for larger bottles over 2L.
This is a common practice in many research laboratories but putting foil over the mouths of glass containers decreases the likelihood of those items being properly sterilized to begin with. The foil must be applied loosely to allow steam penetration and then offers no protection against contamination after sterilization.
Steam sterilization is recommended at +121, +126 or +134 °C, depending on application. For guidance, the British Standard BS EN 285: 8.3.1 states: "The holding time shall be not less than 15 min, 10 min and 3 min for sterilization temperatures of 121 °C, 126 °C and 134 °C respectively."
It is good practice to use either a biological or chemical indicator to confirm that the autoclave is working properly. If either indicator fails, the autoclave must be examined to identify and correct the problem. It is also critical to re-autoclave the load once the issue is addressed to ensure sterility.
Autoclave tape can also be placed on items, with marks on the tape becoming visible once critical temperatures are reached. However, unlike other methods such as biological indicators, autoclave tape does not provide confirmation of sterilization. Instead, it can be used to identify autoclaved vs. non-autoclaved items.
Finally, when unloading the autoclave, ensure you step aside to keep your face and body clear of the door and any steam. It is also advisable to open the door and wait 10 minutes to allow items to cool if possible. Always allow autoclaved materials to cool down to room temperature before transporting.
The number of autoclave cycles that a product can be subjected to depends on the type of glass bottle being autoclaved, with soda lime bottles and plastic-coated bottles able to withstand fewer autoclave cycles than uncoated borosilicate 3.3 laboratory bottles.
Despite the excellent resistance of borosilicate 3.3 to thermal shock, these bottles can be damaged and become unsuitable for autoclaving over time. This is because most of the tensile strength of borosilicate glass resides in the condition of its surface and if the glass is scratched, even sub-microscopically, its strength is greatly reduced. So, while bottles with an unscratched surface will safely survive repeated pressure cycling, older bottles may not.
Unfortunately, it is impossible to predict when an older bottle might fail. DWK Life Sciences therefore recommends the replacement of articles on a routine basis and that each article should be thoroughly inspected visually prior to use for any signs of scratches, chips, or other defects. If found, the product should be removed from service and discarded immediately.
Contact us to discuss your requirements of commercial glass bottle sterilizer. Our experienced sales team can help you identify the options that best suit your needs.