No. Based on the physical and chemical properties of the product, some products do not have a fixed expiration date.
How to check the expiration date of the product?
Our CoA (Quality Inspection Report) will provide information on expiration dates or recommended re-inspection dates for specific products and batches. You can download the CoA on the official website according to the product number and lot number (Lot number), and there will be an expiration date on the CoA.
How long is the validity period of the received product at least?
We promise that when customers receive the goods, there will be at least three months before the expiration date on the label or quality inspection report.
If the product has passed the expiration date, can I continue to use it?
It is not recommended for you to use. There is no guarantee for the quality of products beyond the expiration date. It is recommended that you purchase new batches of products for experimentation.
Document Lookup
How to download the Quality Inspection Report (CoA)?
Official website → enter Technical Support → enter the correct batch number to view or download.
How to download the Safety Data Sheet (MSDS)?
Official website → enter Technical Support → enter the correct batch number to view or download.
Product Packaging
What are the characteristics of the various packaging of the sterility test canisters?
Our packaging is divided into bags and blister boxes, double-layer and single-layer. Sterility testing is an extremely important step before the release of sterile products. False positive, false negative experimental results, experimental equipment failures and human errors will bring significant losses of time and money to customers and directly affect the final release of products. The sterility detection device combined with the bacteria collection instrument and the bacteria collection incubator provides the best solution. Through the peristaltic pump of the bacteria collection instrument, the test products in different packaging forms are safely and evenly transferred to the bacteria collection incubator, so that the sterility test results are more consistent and reliable. The bacteria collection incubator is carefully manufactured through forty processes, and each process is strictly in accordance with the requirements of the ISO9001 quality system and the ISO14001 environmental system. 100% of the products have passed the integrity test, realizing the continuous improvement of quality traceability and quality. According to the inspection requirements of inspection products in different dosage forms and packaging forms, a variety of different cup materials, filter membrane materials and matching needles are specially selected, and a variety of bacteria collection incubators are designed and developed to meet the requirements of sterility inspection for various inspection products. need.
What will be the difference in the packaging of irradiated products?
Irradiation sterilization is the use of high-energy gamma rays emitted by radioisotopes to destroy the biomolecules of microorganisms, thereby completely killing microorganisms. Due to the strong penetrating ability of gamma rays, irradiation sterilization can deeply sterilize the sealed and packaged items in the whole box. The sterilization process is quick and easy, and the irradiated products can be used immediately without worrying about harmful chemicals or radioactive residues.
What are the requirements for the storage conditions of the culture medium?
1. It is recommended to place it in the recommended storage conditions according to the requirements of the product manual.2. Dry powder medium: Even if it can resist light and humidity to a certain extent, it is recommended that customers store it in a dry and dark environment. The optimum storage temperature for dry powder is 15-25 °C (59-77 °F). The pH change caused by long-term storage may be adjusted by acid and alkali. Dry powder medium is easy to absorb moisture, so the bottle cap should be kept tightly closed as much as possible. Dry powder after absorption of water may cause pH changes and caking. It is not recommended to continue to use the dry powder medium that is obviously agglomerated and not easy to crush with a medicine spoon, because the internal chemical composition may change.3. For the prepared medium, the most suitable temperature is 4-12°C and kept away from light. Store in an airtight container or sealed bag to avoid contamination and moisture loss. Medium containing high nutrient components such as blood and egg yolk should be stored at 2-8°C. Plates need to be kept dry and not too hot before being placed in an airtight container. Otherwise too much condensed water in closed containers can cause contamination. Agars with more than 15% water loss may affect the growth of microorganisms, especially Gram-negative bacteria. Excessive loss of water from liquid media can also lead to precipitation and crystallization of certain components.
How to define the validity period of the culture medium?
1. If the unopened medium is stored properly, please refer to the expiry date on the product quality inspection report.For dry powder media, after opening the bottle will be frequently manipulated and exposed to air, so the validity period needs to be redefined. Due to the different usage habits and storage conditions of different laboratories, it is recommended that customers verify the validity period of the opened bottle and stipulate their own validity period after opening the bottle.The validity period of the prepared medium is related to the basic ingredients, formula, whether the preparation process is suitable, sterilization conditions, packaging, and storage conditions. Each laboratory should verify the unique preparation, packaging, and storage conditions of different media to define its own preparation expiration date. For details, please refer to ISO/TS 11133 Guidelines for the production and preparation of microbiological media for food and animal feed.
Can the medium that has been sterilized by radiation be sterilized by high temperature and high pressure?
We generally do not recommend high temperature autoclaving or other heating methods for the medium that has been sterilized by irradiation. If the aseptic simulation filling experiment needs to simulate the two processes of filtration sterilization and high temperature and high pressure steam sterilization, usually the sterilized medium can still provide enough nutrients to ensure the growth of microorganisms, but it is strongly recommended that users add Microbial growth promotion experiment.
Can the medium that has been sterilized by radiation be sterilized by high temperature and high pressure?
The reason for the redness is that part of the oxygen in the bottle is dissolved in the medium and the glucose is oxidized, while the turbid part may be agar precipitated and gathered on the upper surface.Treatment method: After heating in a water bath, the oxygen in the medium is driven out, the agar is dissolved, and the solution returns to yellow and clear. In addition, it is recommended to choose a suitable container when filling after heating and boiling to minimize the air volume in the closed container.
What is sterility testing?
Sterility testing is a GMP microbiology testing requirement used to confirm sterile products do not contain viable microorganisms before release and patient administration. Sterility testing methods must be as accurate as possible, due to their importance for medical devices, pharmaceutical products, and formulations, tissue materials, and other products that claim to be sterile or free from viable microorganisms.Sterility testing procedures are applied to products in many industries, including food and beverage manufacturers, but the main industries are the pharmaceutical and medical sectors where the sterility testing of the products remains a vital and routine task for microbiologists.
Toone Membrane Filtration Sterility Test
Sterility testing is one of the most crucial steps in pharmaceutical product release. The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products, as cited in the USP 71, Ph. Eur 2.6.1, and JP 4.06.Sterility testing membrane filtration devices:The test is particularly suitable for samples containing preservative, bacteriostatic, or fungistatic compounds, which inhibit the microbial growth of potential contaminants. With membrane filtration, microorganisms are retained by a 0.45 µm pore size filter, and all inhibiting compounds are rinsed using a suitable rinse solution. Large volumes and oily products dissolved in emulsifying agents can also be tested by the membrane filtration method, increasing sensitivity and reducing the volume of culture media. Appropriate culture media, selected based upon their ability to support the growth of anaerobic and aerobic microorganisms, are then transferred to the membrane filters. A 14-day incubation period is required to obtain final test results by checking turbidity.Our devices is enriching with some additional elements contributing to significantly improving workflow safety, reliability, and convenience. Our sterility test consumables ensure that pharmaceutical products are never exposed to the environment during the testing process. Filtering, rinsing, media transferring, and incubating are all conducted within the closed system. There is no need to open the containers or manipulate the membrane at any time, thereby greatly reducing the risk of adventitious contamination resulting in false positives.When used with the Toone sterility test pump and accessories, and Toone's culture media and rinsing fluids, our devices offer the highest levels of quality and reliability and a fully regulatory compliant testing process.
Pharmaceutical sterility testing methods
Compendial methods for the sterility testing of pharmaceutical products requires samples to be cultured in two separate media. Two different types of culture media are used in sterility testing to promote the growth of residual anaerobes, as well as aerobes and fungi. Fluid thioglycolate medium (FTM) is typically used to culture anaerobic and some aerobic bacteria, while soybean casein digest medium (SCDM) is typically used to culture fungi and aerobic bacteria. Samples are incubated for 14 days at 32.5°C and 22.5°C respectively, prior to examination. Any turbidity in the culture media may indicate growth and must be investigated. There are two recommended methods of sterility testing for pharmaceuticals: membrane filtration and direct inoculation.
Membrane filtration sterility testing
Membrane filtration sterility testing is the regulatory method of choice for filterable pharmaceutical products, as cited in the USP <71>, EU Pharmacopoeia < 2.6.1>, and JP Pharmacopoeia <4.06>. Samples are passed through a 0.45 µm membrane filter in a filtration canister and culture medium is added for incubation. This method of sterility testing can provide increased sensitivity in comparison to other methods as the whole sample, or a composite sample is passed through a single filter. Filtration also provides an opportunity to rinse away components in the sample that may cause turbidity or inhibit growth, such as antibiotics or preservatives.
Direct inoculation sterility testing
In direct inoculation, a small volume of sample is removed aseptically from the sample unit and inoculated directly into a suitable volume of growth medium before incubation. While simple, this method of testing can have some significant limitations. Only small volumes of product can be inoculated into the culture medium, limiting the test sensitivity. If the sample appears cloudy or turbid after inoculation, it can be challenging to detect turbidity from microbial growth at the end of the incubation period. Additionally, if the product has antimicrobial properties, the sample must be neutralized so that microbial growth is not inhibited.
