Importance of a Stainless Steel Stability Bottle – Eagle Stainless STB Series 316L Bottles
The general public usually thinks of product testing as the process of determining whether a new medication, non-perishable food or other product is effective and safe to use. However, one more step remains in ensuring safety and efficacy: determining whether a safe and effective drug or product will stay that way and for how long and under what conditions. What environmental conditions does it need to stay stable? How does it need to be stored to maintain shelf life? During Pharmaceutical Manufacturing, many intermediates and or products are manufactured in stainless steel. This may require in-process hold studies and/or final product stability/shelf life studies in stainless steel stability bottles. Stainless steel plays a significant role in the process of determining the stability of a wide variety of intermediates/products – pharmaceutical, food, cosmetic, herbal, chemical, biochemical and more. Stainless steel stability bottles can withstand the extreme moisture, temperature, light and other environmental changes needed for accelerated stability testing. Plus, stainless steel provides stable storage for most materials, with corrosion, oxidation and leaching resistance. Eagle Stainless STB Series 316L Bottles sets the standard for stability/shelf life studies.
Eagle Stainless Stability Bottle Quality
Eagle Stainless is a leader in the pharmaceutical industry due to our commitment to high quality and exceptional customer service. Our USA manufactured, STB-Series stability bottles and endcaps are made with certified, solid-bar 316L stainless steel and a minimum pharmaceutical grade 10 Ra standard interior finish or better. Corners are fully radiused, with seamless interiors, for ease of cleaning and increased durability. Eagle Stainless has filed DMF #14927 to cover STB-Series Bottles and Cap manufacturing processes. An Electropolished finish is standard for the STB Series Stability Bottles and End Caps. This provides the highest quality, smooth, ultraclean finish possible, enhances the formation of a protective chromium oxide layer and increases corrosion resistance. This feature is especially important for long-term stability studies and for a multi-use stability bottle. Eagle also provides quality air/water-tight closure for your stability bottles. For our STB Series stability bottles, a 304 two-segment heavy-duty clamp, 316L stainless steel endcap and a USP Class VI platinum-cured silicone gasket are standard. We offer custom options for gaskets, including EPDM, PTFE, BUNA-N, Viton® and other materials.
To further ensure quality, traceability certification is available for all Eagle 316L stainless steel lots. Heat/lot numbers are engraved on each stability testing bottle and cap.
Stability Bottle Options from Eagle
Eagle Stainless’ stability testing bottles are available in a wide range of standard sizes. Our STB Series bottles, specifically designed for stability testing where storage in stainless steel is required, are available in sizes from 1 mL to 750 mL. For even more options, custom fabrication is available for smaller or larger stability bottles when needed. For both real-time stability testing and accelerated or long-term stability testing, smaller stability bottles provide the option to store several small samples of product to be opened individually at testing points across the timespan of the stability study. This reduces the risk of environmental changes or contamination from opening the stability testing bottle. Optional choices for Eagle STB Series stability testing bottles also include – 304, 317L stainless steel, Hastelloy or others are available upon request. Other customized features are available: fill-vent ports, dip tube cap assembly, as well as other custom configuration of options and fittings.
Whether you are testing liquid, capsule, tablet, powder, or other pharmaceuticals or need food product stability testing, Eagle Stainless is the brand to trust for your stainless steel stability bottle needs. Contact Eagle Stainless today to place your order or discuss your specific requirements for a customized stability testing bottle.